<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" > <channel> <title>Research – Policy & Medicine</title> <atom:link href="https://www.policymed.com/category/research/feed" rel="self" type="application/rss+xml" /> <link>https://www.policymed.com</link> <description>Legal, Regulatory, and Compliance Issues</description> <lastBuildDate>Tue, 11 Feb 2025 16:01:56 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <image> <url>https://www.policymed.com/wp-content/uploads/2018/05/cropped-favicon-32x32.png</url> <title>Research – Policy & Medicine</title> <link>https://www.policymed.com</link> <width>32</width> <height>32</height> </image> <item> <title>NIH Caps Indirect Cost Rates at 15%</title> <link>https://www.policymed.com/2025/02/nih-caps-indirect-cost-rates-at-15.html</link> <comments>https://www.policymed.com/2025/02/nih-caps-indirect-cost-rates-at-15.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Mon, 10 Feb 2025 09:30:59 +0000</pubDate> <category><![CDATA[NIH]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[academic institutions]]></category> <category><![CDATA[biomedical research]]></category> <category><![CDATA[budget cuts]]></category> <category><![CDATA[F&A costs]]></category> <category><![CDATA[federal funding]]></category> <category><![CDATA[grant management]]></category> <category><![CDATA[grant policy]]></category> <category><![CDATA[indirect costs]]></category> <category><![CDATA[Medical Research]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[overhead rates]]></category> <category><![CDATA[public health]]></category> <category><![CDATA[research administration]]></category> <category><![CDATA[research capacity]]></category> <category><![CDATA[research funding]]></category> <category><![CDATA[research infrastructure]]></category> <category><![CDATA[science policy]]></category> <category><![CDATA[scientific community]]></category> <category><![CDATA[scientific innovation]]></category> <category><![CDATA[university research]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=17686</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="1280" height="720" src="https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" fetchpriority="high" srcset="https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments.jpg 1280w, https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments-300x169.jpg 300w, https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments-1024x576.jpg 1024w, https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments-768x432.jpg 768w" sizes="(max-width: 1280px) 100vw, 1280px" /></div>In a move that has woken the biomedical research community, the National Institutes of Health (NIH) announced on Friday, February 7, 2025, that beginning February 10, 2025 it will cap indirect cost rates at 15% for all grants, both new and existing. This dramatic policy shift represents a significant reduction from the historical average of […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1280" height="720" src="https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments.jpg 1280w, https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments-300x169.jpg 300w, https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments-1024x576.jpg 1024w, https://www.policymed.com/wp-content/uploads/2025/02/NIH-Indirect-Payments-768x432.jpg 768w" sizes="(max-width: 1280px) 100vw, 1280px" /></div><p>In a move that has woken the biomedical research community, the National Institutes of Health (NIH) announced on Friday, February 7, 2025, that beginning February 10, 2025 it <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-068.html">will cap indirect cost rates at 15%</a> for all grants, both new and existing. This dramatic policy shift represents a significant reduction from the historical average of 27-28% indirect cost rates, with some institutions previously receiving over 60%.</p> <p><strong>Total Grant Funding</strong></p> <p>In fiscal year 2023, <a href="https://www.nih.gov/about-nih/what-we-do/impact-nih-research/serving-society/direct-economic-contributions">NIH spent</a> approximately $35 billion on nearly 50,000 competitive grants awarded to more than 300,000 researchers at over 2,500 institutions across the United States.</p> <p><strong>Indirect Costs (Overhead Payments)</strong></p> <p>According to a recent <a href="https://www.forbes.com/sites/michaeltnietzel/2025/02/08/nih-cuts-back-its-payment-of-indirect-costs-for-university-research/">Forbes Article</a>, of the total grant funding:</p> <ul> <li>Approximately $26 billion went to direct costs for research</li> <li>About $9 billion was allocated to indirect costs through NIH’s indirect cost rate</li> <li>DOGE estimates the new rate will save approximately $4 Billion</li> </ul> <p><strong>Historical Context</strong></p> <p>The average NIH indirect cost rate has historically been between 27% and 28% of the total grant amount. However, some institutions have negotiated much higher rates for indirect costs:</p> <ul> <li>Harvard University: 69%</li> <li>Yale University: 67.5%</li> <li>Johns Hopkins University: 63.7%</li> </ul> <p>In looking at several land grant institutions their negotiated rates for overhead are not that much lower than the top schools:</p> <ul> <li>University of Iowa: 55.5%</li> <li>University of Florida 52.5%</li> <li>University of Mississippi 46%</li> </ul> <p style="text-align: left;">A <a href="https://www.gao.gov/assets/gao-13-760.pdf">2013 Government Accountability Office (GAO)</a> report revealed that the top 50 universities with the largest research programs received over two-thirds of NIH’s total indirect cost reimbursements.</p> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-059.html#:~:text=2%20CFR%20200.414(f)%20%2D,indirect%20cost%20rate%20of%2015%25.">In 2024, a policy change increased the lowest indirect cost rate from 10% to 15%</a> while reducing oversight by removing the requirement to publish these costs publicly and limiting audits.</p> <p>Bills have been introduced in <a href="https://www.congress.gov/bill/118th-congress/house-bill/6847/text">Congress to Study Indirect Costs</a></p> <p><strong>Key Points of the New Policy</strong></p> <ul> <li>A standard 15% indirect cost rate will now apply across all NIH grants, effective immediately.</li> <li>The policy affects both new grants and existing grants for expenses incurred from February 10, 2025 onward.</li> <li>NIH cites alignment with private foundation practices as justification, noting that many foundations offer lower indirect cost rates.</li> </ul> <p><strong>What are Indirect Costs</strong></p> <p>Indirect costs, also known as Facilities and Administrative (F&A) costs, are expenses that cannot be readily identified with a specific research project but are necessary for the general operation of an institution and the conduct of research activities.</p> <p>For NIH grants, these costs typically include expenses such as building maintenance, utilities, administrative support, and library services. The concept of indirect costs was introduced to ensure that research institutions could recover the full cost of conducting federally funded research, not just the direct expenses associated with a specific project.</p> <p>Indirect cost rates are negotiated between research institutions and the federal government, usually through the Department of Health and Human Services or the Department of Defense, rather than with NIH directly. These rates are negotiated on an institution-wide basis, not grant-by-grant, to streamline the process and ensure consistency across federal funding agencies. The negotiated rate is then applied to the modified total direct costs (MTDC) of each grant to determine the indirect cost reimbursement.</p> <p>This system stated aim is to provide a fair and efficient method for institutions to recover the broader costs associated with maintaining a research infrastructure, while allowing researchers to focus on the direct costs of their specific projects. NACUBO has a <a href="https://www.youtube.com/watch?v=2aLEpOhflME">good video</a> outlining how indirect costs work in addition <a href="https://www.youtube.com/watch?v=1XvVibv2opQ&t=33s">NIH has a video as well</a>.</p> <p><strong>What does this look like for a Grant</strong></p> <p><a href="https://nexus.od.nih.gov/all/2024/02/21/fy-2023-by-the-numbers-extramural-grant-investments-in-research/">According to the NIH</a> In Fiscal Year 2023 the average size of a NIH Grant was $609,702.</p> <p>In doing the math we came up with institutions with a 50% overhead receiving an average grant will receive an average over $210,000 less in payments from an average grant and institutions with 30% overhead will see over $91,000 in less payments from each grant.</p> <p>Note in Harvard’s case less than 1/3rd is spent on the actual research and a staggering 69% is spent on “overhead”.</p> <p>Critics argue that such high overhead rates are often poorly defined and may not always be justified. They contend that these costs should be evaluated on a case-by-case basis rather than applied as a blanket percentage.</p> <p><strong>Objections to High Indirect Cost Rates</strong></p> <p>Several key objections to high indirect cost rates have been raised:</p> <p><strong>Lack of Transparency</strong>: The 2024 policy change reduced oversight by removing the requirement to publish these costs publicly and limiting audits.</p> <p><strong>Inconsistent Practices</strong>: Universities accept far lower indirect cost rates from private foundations (e.g., 10% from the Gates Foundation, 15% from the Packard Foundation) while claiming higher NIH rates are necessary for research survival.</p> <p><strong>Concentration of Funds</strong>: The 2013 GAO report highlighted that a small number of large research universities received a disproportionate share of indirect cost reimbursements.</p> <p><strong>Potential for Misuse</strong>: As illustrated by the CMS grant example, there are concerns about institutions using high overhead rates as “gravy” rather than for legitimate research support costs.</p> <p><strong>Impact on Smaller Institutions</strong>: High indirect cost rates may disadvantage smaller research institutions that cannot negotiate favorable rates.</p> <p><strong>More Research Could Be Conducted</strong>: An argument can be made that moving forward more resources will be dedicated to direct research costs vs. overhead.</p> <p><strong>Impact on Research Institutions</strong></p> <p>The implications of this policy change are potentially far-reaching:</p> <ol> <li><strong>Financial Strain</strong>: Many universities and research institutions are expected to face substantial budget shortfalls, potentially hundreds of millions of dollars annually.</li> <li><strong>Research Capacity</strong>: There are concerns that institutions may need to scale back research activities or divert funds from other areas to maintain research infrastructure.</li> <li><strong>Competitive Landscape</strong>: Some experts warn this could lead to a decline in U.S. biomedical research dominance.</li> </ol> <p>Dr. David J. Skorton, President and CEO of the AAMC, and Dr. Elena Fuentes-Afflick, Chief Scientific Officer, stated: “Make no mistake. This announcement will mean less research. Lights in labs nationwide will literally go out. Researchers and staff will lose their jobs.”</p> <p><strong>Other Government Negotiations</strong></p> <p>Because these overhead rates are negotiated across governmental agencies, it is unclear what will happen at DOD, DOA or in other HHS entities. Other negotiations may start from a take-it-or-leave-it-type stance as instituted over the weekend, such as drug price negotiations or physician payments.</p> <p>Basic and Clinical research may move to more affordable places such as Mississippi, New Mexico or Missouri to ensure adequate resources to complete the research.</p> <p><strong>Looking Ahead</strong></p> <p>In order for this to work If the federal reporting requirements, micro accounting and regulations requirements need to be reduced or eliminated, As the research community grapples with this seismic shift in funding policy, many questions remain about its long-term effects on U.S. biomedical research capabilities. Institutions will need to rapidly adapt their financial strategies, potentially leading to significant changes in how research is conducted and funded in the United States.</p> <p>The coming months will likely see intense debate and possibly legal challenges as stakeholders across the research ecosystem respond to this transformative policy change. The focus will likely be on finding a balance between controlling costs and maintaining the robust research infrastructure that has made the U.S. a leader in biomedical innovation.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2025/02/nih-caps-indirect-cost-rates-at-15.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>This Week in Policy and Medicine – January 26, 2025</title> <link>https://www.policymed.com/2025/01/this-week-in-policy-and-medicine-january-26-2025.html</link> <comments>https://www.policymed.com/2025/01/this-week-in-policy-and-medicine-january-26-2025.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Sun, 26 Jan 2025 09:01:52 +0000</pubDate> <category><![CDATA[CME Grant Disclosure]]></category> <category><![CDATA[Corporate Integrity Agreements]]></category> <category><![CDATA[Drug Shortages]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[HHS]]></category> <category><![CDATA[Letters from Grassley]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[This Week In Policy and Medicine]]></category> <category><![CDATA[Transparency]]></category> <category><![CDATA[Changes to FDA SIUU Guidance Highlight Scientific Soundness Standards]]></category> <category><![CDATA[Clinical Education]]></category> <category><![CDATA[Compliance]]></category> <category><![CDATA[FDA updates]]></category> <category><![CDATA[healthcare costs]]></category> <category><![CDATA[healthcare delivery]]></category> <category><![CDATA[healthcare policy]]></category> <category><![CDATA[HHS initiatives]]></category> <category><![CDATA[managed care]]></category> <category><![CDATA[Medical Devices]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[patient outcomes]]></category> <category><![CDATA[physician decision-making]]></category> <category><![CDATA[price transparency]]></category> <category><![CDATA[regulatory insights]]></category> <category><![CDATA[research funding]]></category> <category><![CDATA[telemedicine services]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=17619</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="466" height="355" src="https://www.policymed.com/wp-content/uploads/2025/01/This-week-in-Policy-and-Medicine.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2025/01/This-week-in-Policy-and-Medicine.jpg 466w, https://www.policymed.com/wp-content/uploads/2025/01/This-week-in-Policy-and-Medicine-300x229.jpg 300w" sizes="(max-width: 466px) 100vw, 466px" /></div>Welcome to the latest installment of “This Week in Policy and Medicine,” your essential digest of healthcare policy developments. As always, our detailed analysis is available on Spotify and your favorite podcast platforms. Listen on Spotify This Week’s Highlights: Bridging the Gap: HHS’s New Initiatives The Department of Health and Human Services (HHS) is focusing […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="466" height="355" src="https://www.policymed.com/wp-content/uploads/2025/01/This-week-in-Policy-and-Medicine.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2025/01/This-week-in-Policy-and-Medicine.jpg 466w, https://www.policymed.com/wp-content/uploads/2025/01/This-week-in-Policy-and-Medicine-300x229.jpg 300w" sizes="auto, (max-width: 466px) 100vw, 466px" /></div><p>Welcome to the latest installment of “<a href="https://open.spotify.com/show/thisweekinpolicyandmedicine">This Week in Policy and Medicine</a>,” your essential digest of healthcare policy developments. As always, our detailed analysis is available on Spotify and your favorite podcast platforms. <a href="https://open.spotify.com/show/thisweekinpolicyandmedicine">Listen on Spotify</a></p> <p><strong>This Week’s Highlights:</strong></p> <p><strong>Bridging the Gap: HHS’s New Initiatives</strong> The Department of Health and Human Services (HHS) is focusing on narrowing the divide between research funding and clinical education. This initiative aims to enhance how clinical practices implement groundbreaking research to improve patient outcomes. Read more about the implications for healthcare providers and researchers. <a href="https://www.policymed.com/2025/01/hhs-bridging-the-gap-between-research-funding-and-clinical-education.html">Read more</a></p> <p><strong>Final FDA SIUU Guidance: Key Updates Explained</strong> The Food and Drug Administration (FDA) has released its final guidance on the Special Investigational Use Unit (SIUU), which outlines critical updates for the regulatory processes affecting medical devices. Our breakdown helps you understand the essentials of these updates. <a href="https://www.policymed.com/2025/01/final-fda-siuu-guidance-understanding-the-key-updates.html">Read more</a></p> <p><strong>HHS OIG’s Latest Report on Price Transparency</strong> The Office of Inspector General (OIG) at HHS has published a new report scrutinizing compliance with the hospital price transparency rule. This report reveals key insights into how hospitals are adhering to regulations aimed at making healthcare costs clearer for patients. <a href="https://www.policymed.com/2025/01/hhs-oig-releases-report-on-compliance-with-hospital-price-transparency-rule.html">Read more</a></p> <p><strong>AMCP’s Report on Managed Care Pharmacy</strong> The Academy of Managed Care Pharmacy (AMCP) has released a comprehensive report detailing the current landscape and future directions of managed care pharmacy. This report is a must-read for those involved in healthcare delivery and pharmaceutical management. <a href="https://www.policymed.com/2025/01/amcp-releases-report-on-managed-care-pharmacy.html">Read more</a></p> <p><strong>Variations in Telemedicine Offerings</strong> A new study highlights the variability in telemedicine services across different physician specialties and age groups, among other factors. Discover how these differences impact patient access to virtual care. <a href="https://www.policymed.com/2025/01/telemedicine-offerings-vary-based-on-physician-specialty-and-age-among-other-factors.html">Read more</a></p> <p><strong>Understanding the Limits of PDABs</strong> Our analysis of Physician Decision Aid Bulletins (PDABs) provides insights into their potential and limitations within the healthcare system. Learn more about the role PDABs play in physician decision-making processes. <a href="https://www.policymed.com/2025/01/the-limits-of-pdabs.html">Read more</a></p> <p>Stay informed on the latest in healthcare policy with “<a href="https://open.spotify.com/show/thisweekinpolicyandmedicine">This Week in Policy and Medicine</a>.” Our coverage provides the insights needed to understand the evolving landscape and how it impacts you. For a deeper dive into these topics, don’t forget to check out our podcast series on Spotify and other popular platforms.</p> <p>For more information and continuous updates, visit <a href="https://www.policymed.com">Policy and Medicine</a>.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2025/01/this-week-in-policy-and-medicine-january-26-2025.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Final FDA SIUU Guidance: Understanding the Key Updates and Resources</title> <link>https://www.policymed.com/2025/01/final-fda-siuu-guidance-understanding-the-key-updates.html</link> <comments>https://www.policymed.com/2025/01/final-fda-siuu-guidance-understanding-the-key-updates.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Fri, 24 Jan 2025 09:23:49 +0000</pubDate> <category><![CDATA[Drug Shortages]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[Changes to FDA SIUU Guidance Highlight Scientific Soundness Standards]]></category> <category><![CDATA[Differences Between Draft and Final FDA SIUU Guidance Explained]]></category> <category><![CDATA[FDA Clarifies Real-World Data Use in SIUU Communications]]></category> <category><![CDATA[FDA Final Guidance Updates Rules for Sharing Scientific Information]]></category> <category><![CDATA[FDA Finalizes Guidance on Scientific Information on Unapproved Uses]]></category> <category><![CDATA[FDA Finalizes SIUU Guidance Pending OMB Decision]]></category> <category><![CDATA[FDA Guidance Aligns Scientific Rigor With Communication Standards]]></category> <category><![CDATA[FDA Guidance Balances Innovation With Regulatory Oversight]]></category> <category><![CDATA[FDA Guidance on Unapproved Use Communications Released]]></category> <category><![CDATA[FDA Updates Communication Policies for Firms Sharing Scientific Data]]></category> <category><![CDATA[FDA Updates Compliance Expectations for SIUU Communications]]></category> <category><![CDATA[Final SIUU Guidance Details Communication Rules for Unapproved Uses]]></category> <category><![CDATA[Final SIUU Guidance Emphasizes Truthful and Non-Misleading Communication]]></category> <category><![CDATA[Final SIUU Guidance Refines Recommendations for Source Publications]]></category> <category><![CDATA[Final SIUU Guidance Supports Regulatory Compliance and Patient Safety]]></category> <category><![CDATA[Medical Affairs Departments Must Adapt to New SIUU Guidance]]></category> <category><![CDATA[Medical Affairs Teams Face New SIUU Guidance Requirements]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[SIUU Guidance Enhances Scrutiny of Scientific Information Sources]]></category> <category><![CDATA[SIUU Guidance Requires Separate Spaces for Approved and Unapproved Use Discussions]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=17593</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on Scientific Information on Unapproved Uses (SIUU), Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers. The final guidance details how pharmaceutical companies and medical […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/10/stencil.default-60-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on Scientific Information on Unapproved Uses (SIUU), <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/communications-firms-health-care-providers-regarding-scientific-information-unapproved-uses">Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers</a>. The final guidance details how pharmaceutical companies and medical device manufacturers can communicate scientific information about unapproved uses of approved products without crossing into promotional territory.</p> <p>This final guidance builds upon the draft guidance by emphasizing the need for communications to be truthful, non-misleading, and supported by scientifically sound evidence. Notably, the final guidance clarifies the conditions under which real-world data can be considered in communications, expanding the scope beyond controlled clinical trial data.</p> <p>As of the writing of this article, this guidance is not for current implementation, and is pending the Office of Management and Budget’s (OMB’s) decision on the collection of information. Comments can be submitted by February 21, 2025.</p> <p>Changes from the draft to the final guidance include (1) reorganizing the guidance to include dedicated glossary and policy sections for ease of use; (2) revising the recommendations for source publications to provide additional specificity and examples to illustrate the recommendations; (3) refining language around presentational considerations to provide additional clarity and an additional example; and (4) updating the section on firm-generated presentations to specify that the recommendations apply to firm-generated presentations of scientific information from any of the source publications addressed in the guidance. Some additional editorial changes were also made for clarity.</p> <p><strong>Key Differences Between the Draft and Final Guidance</strong></p> <p>The transition from the draft to the final guidance marks a change in development in regulatory expectations. One difference is that the final guidance emphasizes “scientific soundness” over the draft’s “scientifically sound and clinically relevant” standard, urging reliance on well-designed and controlled studies. It removes specific endorsements of real-world data, instead suggesting a more nuanced approach to evaluating scientific evidence. However, while it no longer emphasizes “clinically relevant,” the need for clinical relevance does still seem to be a factor and it is incorporated into the “scientifically sound” standard.</p> <p>In the final guidance, the FDA also points out study design features that would generally meet the “scientifically sound” standard, such as a robust design and a prespecified statistical analysis plan. Also, certain phase II studies <em>could</em> meet the “scientifically sound” standard when adequately designed and conducted, as could other less-conventional study designs.</p> <p>In the final guidance, FDA also notes that appropriate source publications for firm-generated presentations include clinical practice guidelines, scientific or medical reference texts, and digital clinical practice resources – in addition to published scientific or medical journal articles.</p> <p>The final guidance also updates the draft guidance’s indication that SIUU and promotional communications must be “separate and distinct” to simply saying they must be “separate.” Even still, the standard remains essentially the same as FDA emphasizes that companies should maintain dedicated spaces for discussion of unapproved uses apart from where approved uses are promoted – such as separate webpages, email messages, and physical spaces within a commercial exhibit booth. For in-person discussions, the SIUU communication(s) should be clearly identified through the ”clear and prominent presentation of the disclosures” recommended in the guidance.</p> <p>Companies should evaluate existing scientific knowledge critically to determine the appropriateness of source publications for SIUU communications. This shift requires medical affairs teams to enhance their scrutiny and verification of the scientific rigor of the data they disseminate.</p> <p>For medical affairs and compliance departments, these updates necessitate a thorough review of current practices and possibly, the development of new training and compliance checks to ensure all communications align with the updated FDA expectations.</p> <p><strong>Further Reading and Resources</strong></p> <p>To fully integrate the new SIUU guidance into your operational strategies, detailed understanding and continual reference to the official FDA document will be essential. You can access the final SIUU guidance directly through the FDA’s <a href="https://www.fda.gov/media/184871/download">official guidance document</a>.</p> <p>This guidance serves not only to protect patients by ensuring they receive accurate information but also helps firms navigate complex regulatory landscapes without compromising their ability to share valuable scientific knowledge.</p> <p><strong>Important Resources and Further Reading</strong></p> <ul> <li><strong>Comprehensive FDA Guidance Resources</strong>: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/communications-firms-health-care-providers-regarding-scientific-information-unapproved-uses">FDA’s guidance on communications</a>, offering insights into broader regulatory policies.</li> <li><strong>Federal Register Notice</strong>: <a href="https://www.federalregister.gov/documents/2025/01/07/2024-31539/communications-from-firms-to-health-care-providers-regarding-scientific-information-on-unapproved">Details on public feedback and regulatory considerations for SIUU</a>.</li> <li><strong>Draft Guidance 2023 </strong><a href="https://www.fda.gov/media/173172/download"><strong>Access Draft Guidance</strong></a></li> <li><strong>FDA Law Blog Overview</strong>: <a href="https://www.thefdalawblog.com/2025/01/siuu-siuu-sudio-fda-finalizes-guidance-on-siuu-and-distribution-of-off-label-information/">Insightful analysis on the finalized SIUU guidance</a>, providing context and implications for the industry.</li> <li><strong>Troutman Law </strong><a href="https://www.troutman.com/insights/fda-finalizes-guidance-on-communications-regarding-unapproved-uses-of-medical-products.html"><strong>Firm Review of Final FDA SIUU Guidance</strong></a></li> <li><strong>Hogan and Lovells </strong><a href="https://www.jdsupra.com/legalnews/fda-finalizes-guidance-for-7125941/"><strong>Review of Final FDA SIUU Guidance</strong></a></li> <li><strong>Arnold and Porter </strong><a href="https://www.arnoldporter.com/en/perspectives/advisories/2025/01/fda-finalizes-its-siuu-guidance"><strong>Review of Final FDA SIUU Guidance</strong></a></li> </ul> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2025/01/final-fda-siuu-guidance-understanding-the-key-updates.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>This Week in Policy and Medicine, December 14, 2024</title> <link>https://www.policymed.com/2024/12/this-week-in-policy-and-medicine-december-14-2024.html</link> <comments>https://www.policymed.com/2024/12/this-week-in-policy-and-medicine-december-14-2024.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Sun, 15 Dec 2024 09:05:35 +0000</pubDate> <category><![CDATA[CME Grant Disclosure]]></category> <category><![CDATA[Corporate Integrity Agreements]]></category> <category><![CDATA[Drug Shortages]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Letters from Grassley]]></category> <category><![CDATA[Maintenance of Certification]]></category> <category><![CDATA[Physician Payment Sunshine Act]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[Social Media]]></category> <category><![CDATA[Technology]]></category> <category><![CDATA[Uncategorized]]></category> <category><![CDATA[antitrust settlements]]></category> <category><![CDATA[Continuing medical education]]></category> <category><![CDATA[drug promotion]]></category> <category><![CDATA[FDA oversight]]></category> <category><![CDATA[health misinformation]]></category> <category><![CDATA[healthcare policy]]></category> <category><![CDATA[Healthcare Reform]]></category> <category><![CDATA[legal confrontations]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[pharmaceutical industry]]></category> <category><![CDATA[policy analysis]]></category> <category><![CDATA[price transparency]]></category> <category><![CDATA[regulatory compliance]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=17441</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="1165" height="191" src="https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024.jpg 1165w, https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024-300x49.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024-1024x168.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024-768x126.jpg 768w" sizes="auto, (max-width: 1165px) 100vw, 1165px" /></div>This week on the Policy and Medicine Podcast, we unpack a range of timely and impactful stories that highlight critical changes and discussions in healthcare policy and regulation. Available on Spotify and other podcast platforms, tune in to hear our expert analysis and insights. Here’s a snapshot of the stories covered in this episode: Hospital […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1165" height="191" src="https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024.jpg 1165w, https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024-300x49.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024-1024x168.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/12/This-week-in-Policy-and-Medicine-12-14-2024-768x126.jpg 768w" sizes="auto, (max-width: 1165px) 100vw, 1165px" /></div><p>This week on the <strong><a href="https://open.spotify.com/episode/7aP8JQGefgLIyt6xXeT3TZ">Policy and Medicine Podcast</a></strong>, we unpack a range of timely and impactful stories that highlight critical changes and discussions in healthcare policy and regulation. Available on Spotify and other podcast platforms, tune in to hear our expert analysis and insights. Here’s a snapshot of the stories covered in this episode:</p> <p><strong>Hospital Price Transparency Compliance Drops to 38%</strong> A recent analysis shows a significant drop in hospital compliance with price transparency regulations, now at just 38%. This decline raises concerns about consumer access to price information and the potential impact on healthcare costs. Continued enforcement and increased penalties are being discussed as potential solutions to ensure hospitals meet transparency requirements. <a href="https://www.policymed.com/2024/12/hospital-price-transparency-compliance-drops-38.html">Read more</a></p> <p><strong>Generic Drugmakers Reach $50 Million in Antitrust Settlements</strong> In a major development, generic drug manufacturers have agreed to nearly $50 million in settlements related to antitrust violations in multidistrict litigation. This settlement addresses the alleged price-fixing schemes that affected the cost of several widely used medications, highlighting ongoing issues within the pharmaceutical industry. <a href="https://www.policymed.com/2024/12/generic-drugmakers-reach-nearly-50-million-in-antitrust-settlements-in-multidistrict-litigation.html">Read more</a></p> <p><strong>OPDP Issues Untitled Letter to Merz Pharmaceuticals</strong> The Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Merz Pharmaceuticals concerning a recent social media post that allegedly promotes an approved drug in a misleading manner. This action underscores the FDA’s continued focus on digital marketing practices and the importance of compliant promotional communications. <a href="https://www.policymed.com/2024/12/opdp-sends-untitled-letter-to-merz-over-social-media-post.html">Read more</a></p> <p><strong>Stakeholders Provide Feedback on FDA Misinformation Draft Guidance</strong> The FDA’s recent draft guidance on health misinformation has received extensive feedback from various stakeholders. Industry leaders, healthcare professionals, and advocacy groups are contributing insights, aiming to shape a balanced approach that addresses misinformation without stifling scientific discourse. <a href="https://www.policymed.com/2024/12/stakeholders-provide-feedback-on-fda-misinformation-draft-guidance.html">Read more</a></p> <p><strong>Steward Health CEO Held in Contempt of Congress</strong> In an unprecedented move, the CEO of Steward Health has been held in contempt of Congress for refusing to testify regarding allegations of misconduct. This legal confrontation highlights the growing tensions between healthcare executives and regulatory authorities. <a href="https://www.policymed.com/2024/12/steward-health-ceo-held-in-contempt-of-congress-for-refusal-to-testify.html">Read more</a></p> <p><strong>Necessary Disruption 2.0: A Continuing Education Call to Action</strong> The “Necessary Disruption 2.0” initiative calls for transformative changes in continuing medical education (CME). It aims to better align educational practices with current healthcare challenges, emphasizing innovative learning methods and increased accountability in CME programs. <a href="https://www.policymed.com/2024/12/necessary-disruption-2-0-a-continuing-education-call-to-action.html">Read more</a></p> <p>For more details on these topics, visit <a href="https://www.policymed.com">PolicyMed.com</a>. Tune into our <strong><a href="https://open.spotify.com/episode/7aP8JQGefgLIyt6xXeT3TZ">This Week in Policy and Medicine Podcast on Spotify</a></strong> and other podcast platforms to hear more in-depth discussions on these crucial issues.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2024/12/this-week-in-policy-and-medicine-december-14-2024.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>FDA Issues Reports on Communication and Guidance Document Best Practices</title> <link>https://www.policymed.com/2024/12/fda-issues-reports-on-communication-and-guidance-document-best-practices.html</link> <comments>https://www.policymed.com/2024/12/fda-issues-reports-on-communication-and-guidance-document-best-practices.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Thu, 05 Dec 2024 09:04:44 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[communication strategies]]></category> <category><![CDATA[digital communication tools]]></category> <category><![CDATA[FDA reports]]></category> <category><![CDATA[FDA updates]]></category> <category><![CDATA[Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance]]></category> <category><![CDATA[guidance documents]]></category> <category><![CDATA[healthcare compliance]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[public health]]></category> <category><![CDATA[regulatory best practices]]></category> <category><![CDATA[stakeholder engagement]]></category> <category><![CDATA[transparency in regulation]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=17405</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="502" height="379" src="https://www.policymed.com/wp-content/uploads/2024/12/FDA-headquarters.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/12/FDA-headquarters.jpg 502w, https://www.policymed.com/wp-content/uploads/2024/12/FDA-headquarters-300x226.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/12/FDA-headquarters-86x64.jpg 86w" sizes="auto, (max-width: 502px) 100vw, 502px" /></div>The US Food and Drug Administration (FDA) has published reports on communications and guidance documents as mandated by Congress in the Consolidated Appropriations Act of 2023. These documents detail the FDA’s proposed strategies for enhancing communication with stakeholders and refining the development and issuance of guidance documents, informed by the agency’s experience during the COVID-19 […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="502" height="379" src="https://www.policymed.com/wp-content/uploads/2024/12/FDA-headquarters.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/12/FDA-headquarters.jpg 502w, https://www.policymed.com/wp-content/uploads/2024/12/FDA-headquarters-300x226.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/12/FDA-headquarters-86x64.jpg 86w" sizes="auto, (max-width: 502px) 100vw, 502px" /></div><p>The US Food and Drug Administration (FDA) <a href="https://www.fda.gov/regulatory-information/guidances/background-fda-good-guidance-practices">has published reports</a> on communications and guidance documents as mandated by Congress in the Consolidated Appropriations Act of 2023. These documents detail the FDA’s proposed strategies for enhancing communication with stakeholders and refining the development and issuance of guidance documents, informed by the agency’s experience during the COVID-19 pandemic.</p> <p><strong>Evaluating FDA’s Communication Enhancements</strong></p> <p>The report delves into the FDA’s revised strategies for communication, aimed at improving transparency and effectiveness in interactions with stakeholders from the pharmaceutical and medical device sectors. It suggests adopting new digital communication tools and enhancing the clarity of regulatory expectations. These proposals are designed to help stakeholders navigate regulatory processes more efficiently, though their practical impact remains to be seen.</p> <p><strong>Streamlining Guidance Document Processes</strong></p> <p>Following the 2023 public comment period on its draft titled “Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance,” the FDA has released a <a href="https://www.fda.gov/media/183214/download">final report</a> outlining a strategy for the development, issuance, and application of guidance documents. This strategy includes making these processes more predictable and user-friendly.</p> <p><strong>Key Aspects of the Best Practices for Guidance</strong></p> <p>The final report includes several initiatives:</p> <ul> <li><strong>Prioritization Framework:</strong> Introducing criteria to prioritize guidance documents based on public health impacts, applicability across the industry, and urgency.</li> <li><strong>Streamlined Development:</strong> Proposing faster development cycles and enhanced collaboration tools for creating guidance documents.</li> <li><strong>Transparency Enhancements:</strong> Pledging to provide regular updates on the progress of guidance documents and establishing clear timelines for their release.</li> <li><strong>Stakeholder Engagement:</strong> Aiming to improve the feedback mechanism on draft guidances through more public meetings and extended comment periods.</li> </ul> <p><strong>Public Input and FDA’s Response</strong></p> <p>The FDA has stressed the importance of public engagement in shaping these reports, following section 2505(c) of the Consolidated Appropriations Act. Feedback from a diverse group of stakeholders, including industry professionals and patient advocacy groups, was considered in the finalization of these strategies.</p> <p><strong>Access and Implications</strong></p> <p>These reports are accessible on the FDA’s website and provide a comprehensive look at the proposed regulatory changes. They are relevant for those involved in healthcare regulation, offering insights into the FDA’s strategic direction and its implications for industry practices.</p> <p><strong>Looking Forward</strong></p> <p>These updates from the FDA represent an attempt to streamline regulatory processes and enhance stakeholder communication. The effectiveness of these new strategies in improving regulatory efficiency and transparency will need to be monitored over time.</p> <p><strong>Resources</strong></p> <p><a href="https://www.fda.gov/media/183214/download">FDA Report and Plan on Best Practices for Guidance</a></p> <p><a href="https://www.federalregister.gov/documents/2024/01/03/2023-28872/food-and-drug-administrations-draft-report-and-plan-on-best-practices-for-guidance-availability">Federal Register Notice Announcing availability of the Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance</a></p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2024/12/fda-issues-reports-on-communication-and-guidance-document-best-practices.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Unlocking the Fatty Liver Mistry: The Silent Threat of Fatty Liver Disease Unveiled</title> <link>https://www.policymed.com/2024/11/unlocking-the-fatty-liver-mistry-the-silent-threat-of-fatty-liver-disease-unveiled.html</link> <comments>https://www.policymed.com/2024/11/unlocking-the-fatty-liver-mistry-the-silent-threat-of-fatty-liver-disease-unveiled.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Sun, 17 Nov 2024 09:11:07 +0000</pubDate> <category><![CDATA[Clinical Research]]></category> <category><![CDATA[Collaborations]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[fatty liver disease]]></category> <category><![CDATA[healthcare podcast]]></category> <category><![CDATA[lifestyle changes]]></category> <category><![CDATA[liver diagnostics]]></category> <category><![CDATA[liver health]]></category> <category><![CDATA[liver pathology]]></category> <category><![CDATA[liver treatment]]></category> <category><![CDATA[metabolic syndrome]]></category> <category><![CDATA[Neeraj Mistry]]></category> <category><![CDATA[NEW]]></category> <category><![CDATA[Obesity]]></category> <category><![CDATA[public health]]></category> <category><![CDATA[silent diseases]]></category> <category><![CDATA[social determinants of health]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=17334</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="556" height="342" src="https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1.jpg 556w, https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1-300x185.jpg 300w" sizes="auto, (max-width: 556px) 100vw, 556px" /></div>In the inaugural episode of “Unlocking the Fatty Liver Mistry,” Dr. Neeraj Mistry, Chief Medical Officer of the Fatty Liver Foundation, shares crucial insights on the often-overlooked health issue—fatty liver disease. With an approachable blend of medical expertise and public health perspective, Dr. Mistry invites listeners to explore the intricate world of liver health and […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="556" height="342" src="https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1.jpg 556w, https://www.policymed.com/wp-content/uploads/2024/11/Mistry-Episode-1-300x185.jpg 300w" sizes="auto, (max-width: 556px) 100vw, 556px" /></div><p>In the inaugural episode of “<a href="https://clinicalcaresolutions.net/activities/gastroenterology/video-update1-dr-neeraj-mistry/61655/content">Unlocking the Fatty Liver Mistry</a>,” Dr. Neeraj Mistry, Chief Medical Officer of the Fatty Liver Foundation, shares crucial insights on the often-overlooked health issue—fatty liver disease. With an approachable blend of medical expertise and public health perspective, Dr. Mistry invites listeners to explore the intricate world of liver health and the silent epidemic affecting one-third of the global population.</p> <p><strong>A Deeper Look at Fatty Liver Disease</strong></p> <p>Fatty liver disease, commonly brushed aside in medical training, manifests silently within a significant portion of the population, emerging as a pivotal subject in contemporary health discussions. Dr. Mistry articulates the disease’s stealthy nature, emphasizing its lack of symptoms until it progresses to more severe stages, like cirrhosis or liver failure.</p> <p><strong>The Role of Lifestyle and Social Determinants</strong></p> <p>The conversation shifts towards the broader spectrum of factors contributing to fatty liver disease, including lifestyle choices and social determinants of health. Dr. Mistry highlights the critical role of diet, medication, and substance intake on liver health, pointing out the liver’s remarkable resilience until pushed past its limits.</p> <p><strong>Comorbidities and Global Impact</strong></p> <p>Dr. Mistry discusses the intersection of fatty liver disease with conditions like obesity, diabetes, and metabolic syndrome, noting a worrying rise in obesity rates among adults and children in the United States. This intersection underscores the urgent need to address these lifestyle diseases, which are expected to increase in prevalence, normalizing chronic health issues that lead directly to liver complications.</p> <p><strong>Future Directions and Community Engagement</strong></p> <p>Looking forward, Dr. Mistry reveals plans for upcoming episodes that will delve into the pathology, diagnostics, and new treatments for fatty liver disease. He expresses enthusiasm for community-based screenings that have shown promising engagement results, with individuals showing heightened interest in their health when presented with concrete evidence of liver damage.</p> <p><strong>Conclusion: A Call to Action</strong></p> <p>Ending on a hopeful note, Dr. Mistry invites listeners to stay tuned for more detailed discussions on the evolving nomenclature of liver disease and updates from upcoming conferences. His message is clear: understanding and addressing fatty liver disease is not only about treating the liver but also about enhancing overall health through proactive community and healthcare measures.</p> <p>Stay informed and engaged as we continue to <a href="https://clinicalcaresolutions.net/activities/gastroenterology">unravel the mysteries of liver health</a>, emphasizing early detection and holistic management to mitigate this silent epidemic. Join us in our next episode to learn more about the critical changes in how we define and approach liver health today.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2024/11/unlocking-the-fatty-liver-mistry-the-silent-threat-of-fatty-liver-disease-unveiled.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Maine Finalizes Its Physician “Gift Ban” Rules Updates to $500 limit Includes Exemptions for Pharmacists, Speaker Fees, Expenses, Accredited Education and Market Research</title> <link>https://www.policymed.com/2020/06/maine-finalizes-its-physician-gift-ban-rules-to-exclude-pharmacists-speaker-fees-expenses-accredited-education-and-market-research.html</link> <comments>https://www.policymed.com/2020/06/maine-finalizes-its-physician-gift-ban-rules-to-exclude-pharmacists-speaker-fees-expenses-accredited-education-and-market-research.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Mon, 08 Jun 2020 09:02:04 +0000</pubDate> <category><![CDATA[CME]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[State Policy]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=13575</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="682" height="1023" src="https://www.policymed.com/wp-content/uploads/2020/06/Maine-Map.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/06/Maine-Map.png 682w, https://www.policymed.com/wp-content/uploads/2020/06/Maine-Map-200x300.png 200w" sizes="auto, (max-width: 682px) 100vw, 682px" /></div>After a year of rule-making, Maine’s Board of Pharmacy (the “Board”) finally adopted the gift ban rules at its May Public Board Meeting. These rules provide manufacturers and wholesalers clear direction on the state’s gift ban law. In a win for the industry, especially CME providers and Maine-licensed practitioners, the rule does not set a […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="682" height="1023" src="https://www.policymed.com/wp-content/uploads/2020/06/Maine-Map.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/06/Maine-Map.png 682w, https://www.policymed.com/wp-content/uploads/2020/06/Maine-Map-200x300.png 200w" sizes="auto, (max-width: 682px) 100vw, 682px" /></div><p>After a <a href="https://www.maine.gov/pfr/professionallicensing/professions/pharmacy/pdf/notice_of_agency_rule_making_proposal_chapter_12.pdf">year of rule-making</a>, Maine’s Board of Pharmacy (the “Board”) finally adopted the <a href="https://www.maine.gov/pfr/professionallicensing/professions/pharmacy/pdf/final_rule_adoption_chapter_12_licensure_of_manufacturers_and_wholesalers_gifts.pdf">gift ban rules</a> at its May <a href="https://www.maine.gov/pfr/professionallicensing/professions/pharmacy/pub/2020/agenda_may_7_2020.pdf#page=3">Public Board Meeting</a>. These rules provide manufacturers and wholesalers clear direction on the state’s gift ban law. In a win for the industry, especially CME providers and Maine-licensed practitioners, the rule <u>does not</u> set a cap on speaker honoraria and associated expenses.</p> <p>For a refresher, in June of 2017, Maine’s legislature enacted a controversial gift ban <a href="https://legislature.maine.gov/legis/bills/getPDF.asp?paper=HP0639&item=2&snum=128">bill</a> that became <a href="https://www.mainelegislature.org/legis/statutes/32/title32sec13759.html">law</a> without the governor’s signature. The law broadly prohibits manufacturers and wholesalers from offering or giving gifts to health care practitioners licensed by the state of Maine. There are several exceptions, such as providing practitioners educational materials, prescription drug samples, “modest meals and refreshments” in connection with a meeting or presentation, and “reasonable honoraria” and “reasonable expenses” associated with speaking engagements. The law also required the Board to establish rules to define “modest meals and refreshments,” “reasonable honoraria,” and “reasonable expenses.”</p> <p>Proposed regulations issued in April of 2019 ambiguously defined “modest meals and refreshments” as food and beverage of “minimal value,” set a $250 annual cap on honoraria, and considered the “reasonable expenses” associated with honoraria to be “the reasonable and actual expenses for travel, lodging, and meals” that the speaker incurs. The Board did not provide clarity on the scope of the law, whether research-related payments were banned, and the law’s applicability to CME programs. Without clarity, the proposed regulations added to the chilling effect of the broad gift ban law.</p> <p>The <a href="http://www.cmecoalition.org/about.html">CME Coalition</a>, a Washington-based organization comprised of CME providers, beneficiaries of CME, and supporters of CME, <a href="http://www.cmecoalition.org/resources/cme-coalition-comments-on-maine-gift-ban">submitted comments</a> highlighted the chilling effect and asked the Board to “[e]liminat[e] the proposed rule’s strict limitation on the provision of honoraria to faculty members participating in accredited CME activities [to] allow physicians to continue to participate in CME without the risk of conflict-of-interest Maine rightly [sought] to curtail.” Altogether the Board received 117 comments with a majority of the comments from individuals. Notable commenters represented AdvaMed, King & Spalding’s Ad Hoc Sunshine and State Law Compliance Group, Pfizer, BIO, the Insight Association, and Northern Light Health (an integrated health care system in Maine).</p> <p>The Board clarified and addressed areas of ambiguity, such as the meaning of “minimal value” in relation to modest meals and refreshments, “reasonable honoraria,” the scope of the gift ban, and bona fide marketing research. The rules went into effect on Saturday, June 6. The following provides a high-level summary:</p> <ul> <li><strong>Modest Meals and Refreshments:</strong> The Board clarified that “minimal value” in relation to modest meals and refreshments “means the cost of which is similar to that which a practitioner would pay when dining at his or her own expense as judged by local standards where the event is held.” No monetary limits were established by the Board.</li> </ul> <p> </p> <ul> <li><strong>Reasonable Honoraria: </strong>While the Board disagreed on rescinding an annual cap altogether, the Board agreed to increase the cap to $500 annually. Importantly, the Board stated “honoraria is a gift or gratuity in recognition of the practitioner’s presentation and does not include fee for service paid to the practitioner for the presentation, travel or lodging reimbursement, or other expenses incurred.” Further, “[t]he Board agree[d] that if a manufacturer or wholesaler sponsors a conference or meeting event with a dollar donation, and the manufacturer or the wholesaler does not and is not a participant in the selection of the practitioner chosen for the speaking engagement, nor does it influence or pay the practitioner directly, the honoraria limitation does not apply to such professional or educational meeting or presentation events.”This means that speaker fees associated with CME and non-CME programs, along with associated expenses for travel, lodging, and meals, are not subject to the $500 annual cap. The only items subject to the cap are those above and beyond the speaker’s fees (e.g., a token or gift bag; see <a href="https://www.maine.gov/pfr/professionallicensing/professions/pharmacy/pdf/final_rule_adoption_chapter_12_licensure_of_manufacturers_and_wholesalers_gifts.pdf#page=9">Northern Light Health’s comment</a> that the Board highlighted on p. 9).</li> </ul> <p> </p> <ul> <li><strong>Practitioners: </strong>The Board clarified that the term “practitioner” does not include pharmacists. The term “practitioner” is defined by <a href="https://www.mainelegislature.org/legis/statutes/32/title32sec13702-A.html">statute</a> and means “…an individual who is licensed, registered or otherwise authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of professional practice.” Further, the gift ban applies to “Maine licensed practitioners and does not apply to practitioners licensed outside Maine.”</li> </ul> <p> </p> <ul> <li><strong>Bona Fide Marketing Research:</strong> The Board recognized that the gift ban law did not specifically exempt research-related payments. It stated that although the Maine Legislature gave it limited authority (i.e., to define by rule “modest meals and refreshments” and “giving reasonable honoraria”), it “[did] not believe the law prohibits payment to a practitioner for services rendered and would not be a matter subject to Board action.”</li> </ul> <p> </p> <p>The industry, along with Maine-licensed practitioners, should view the final rule as good news. These rules should not disrupt business operations—current modest meal and refreshment limits set by companies should suffice and giving items above and beyond speaker fees and associated expenses are not recommended (should companies choose to, then monitoring will need to be established). Given the Board’s limited authority for rule-making and its position on how it would not take action against companies for making bona fide marketing research payments, we believe this extends to other transfers of value such as all research-related payments and consulting fees.</p> <p>More details on the Maine regulations will be provided in the <a href="https://complianceupdate.policymed.com/">July Issue of Policy and Medicine Compliance Update.</a></p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2020/06/maine-finalizes-its-physician-gift-ban-rules-to-exclude-pharmacists-speaker-fees-expenses-accredited-education-and-market-research.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>OPDP to Study Physicians’ Interpretations of Drug Information</title> <link>https://www.policymed.com/2019/08/opdp-to-study-physicians-interpretations-of-drug-information.html</link> <comments>https://www.policymed.com/2019/08/opdp-to-study-physicians-interpretations-of-drug-information.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Fri, 23 Aug 2019 09:12:51 +0000</pubDate> <category><![CDATA[Government Agencies]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=12590</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="256" height="122" src="https://www.policymed.com/wp-content/uploads/2019/08/6a00e5520572bb883401a51163726a970c.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div>Recently, the United States Food and Drug Administration (FDA) announced its Office of Prescription Drug Promotion (OPDP) plans to conduct a study to determine how factors like information source, graphic presentations, and time influence a physician’s interpretation of information about prescription drugs presented in scientific journals versus promotional materials. According to the Notice, OPDP will […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="256" height="122" src="https://www.policymed.com/wp-content/uploads/2019/08/6a00e5520572bb883401a51163726a970c.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div><p>Recently, the United States Food and Drug Administration (FDA) announced its Office of Prescription Drug Promotion (OPDP) plans to <a href="https://www.federalregister.gov/documents/2019/07/19/2019-15350/agency-information-collection-activities-submission-for-office-of-management-and-budget-review">conduct a study</a> to determine how factors like information source, graphic presentations, and time influence a physician’s interpretation of information about prescription drugs presented in scientific journals versus promotional materials. According to the Notice, OPDP will also look at how the level of methodological rigor of the underlying data impacts interpretation of information.</p> <p>FDA plans to conduct a small pre-test of the study with 158 voluntary participants before moving on to the main study, where the agency plans to enroll a total of 566 voluntary participants. FDA will limit participation to board-certified internists.</p> <p>The study will use mock sales aids (with and without graphical presentations) and medical journal abstracts with either high or low methodologic rigor “to examine the potential differences in perception that may arise by presenting the same information in different vehicles.”</p> <p>To define low levels versus high levels of methodologic rigor, FDA will use criteria developed by Aaron Kesselheim, MD, JD, MPH. The criteria will include whether the study was blinded or open label, whether the population is representative of the patient population, and whether safety data was reported. <a href="https://www.nejm.org/doi/full/10.1056/NEJMsa1202397">Kesselheim previously conducted research</a> that looked at impacts of study quality and funding source on physician perceptions using the criteria, which resulted in findings that indicated physician participants were able to distinguish between levels of methodologic rigor. That study also found that physicians reported less willingness to prescribe the drugs or read the full study from trials that were funded by industry, regardless of study rigor.</p> <p>OPDP plans to test three different contextual presentations of drug information (medical journal abstract, sales aid without graphic design elements, and sales aid with graphic design elements), and two types of study methodological rigor used by Kesselheim. The agency expects to test a mock sales aid presentation and a medical journal abstract to examine the potential differences in perception that may arise by presenting the same information in different vehicles. Mirroring the time constraints of practicing physicians, we will examine the role of time pressure by randomly assigning half of the study participants to a limited amount of available time to read the materials.</p> <p>In order to test how time constraints impact how physicians interpret the materials, FDA says it will randomize the study into two groups: one that is told they have two minutes to review the materials and one that will be told they have unlimited time to review them.</p> <p>OPDP is hoping that through the evaluation of advertising features, it will be able to assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits. Further, in the Federal Register notice, FDA notes that by focusing on target populations, the agency will be able to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2019/08/opdp-to-study-physicians-interpretations-of-drug-information.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>Duke Agrees to Pay $112.5 Million in False Claims Act Settlement Related to Scientific Research Misconduct</title> <link>https://www.policymed.com/2019/04/duke-agrees-to-pay-112-5-million-in-false-claims-act-settlement-related-to-scientific-research-misconduct.html</link> <comments>https://www.policymed.com/2019/04/duke-agrees-to-pay-112-5-million-in-false-claims-act-settlement-related-to-scientific-research-misconduct.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Tue, 09 Apr 2019 09:12:06 +0000</pubDate> <category><![CDATA[DOJ]]></category> <category><![CDATA[False Claims Act]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=12131</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="3208" height="1700" src="https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol.jpg 3208w, https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol-300x159.jpg 300w, https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol-768x407.jpg 768w, https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol-1024x543.jpg 1024w" sizes="auto, (max-width: 3208px) 100vw, 3208px" /></div>Late last month, it was announced that Duke University agreed to settle with the Department of Justice (DOJ) a case involving allegations that the University violated the False Claims Act by submitting applications and progress reports with falsified research on federal grants to the National Institutes of Health (NIH) and to the Environmental Protection Agency […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="3208" height="1700" src="https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol.jpg 3208w, https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol-300x159.jpg 300w, https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol-768x407.jpg 768w, https://www.policymed.com/wp-content/uploads/2019/04/Duke-University-symbol-1024x543.jpg 1024w" sizes="auto, (max-width: 3208px) 100vw, 3208px" /></div><p>Late last month, it was <a href="https://www.justice.gov/opa/pr/duke-university-agrees-pay-us-1125-million-settle-false-claims-act-allegations-related">announced that Duke University agreed to settle</a> with the Department of Justice (DOJ) a case involving allegations that the University violated the False Claims Act by submitting applications and progress reports with falsified research on federal grants to the National Institutes of Health (NIH) and to the Environmental Protection Agency (EPA).</p> <p>According to the <a href="https://www.bloomberglaw.com/product/blaw/exp_blp/eyJjdHh0IjoiRE9DIiwiaWQiOiJYMVE2TlFPMk1CODIiLCJ1dWlkIjoiZ1VRSVpvTkEycHhEenVuZVNzbU9Qdz09RmYzWXlkdUo0a2piTVF0bW9obXB0QT09IiwidiI6MSwidGltZSI6IjE1NTQ3NjI2NTIwMDAiLCJzaWciOiJZejg5Q0xXVWwxN1dQbXVCd1AzMEsweHhjS009In0=">allegations made by Joseph Thomas</a>, a former Duke employee, Duke knowingly submitted and caused to be submitted claims to the NIH and the EPA that contained falsified or fabricated data or statements in thirty grants, causing the NIH and the EPA to pay out grant funds they otherwise would not have. The allegations by Thomas include claims that his former colleague and her supervisor received more than 60 research grants totaling $200 million in funding via falsified applications.</p> <p>The United States <a href="https://casetext.com/case/united-states-ex-rel-thomas-v-duke-univ">specifically contends</a> that the results of certain research related to mice conducted by a Duke research technician in the Airway Physiology Laboratory, as well as statements based on those research results, were falsified and/or fabricated.</p> <p>While universities across the country occasionally find themselves in hot water with the False Claims Act, typically, the allegations that involve universities come out of improper billing to the federal government for salaries or other administrative costs. The False Claims Act allegations and settlement in this case is rare in that it did not involve the standard administrative costs, but instead involved tampering with scientific data.</p> <p>John R. Thomas, Jr., the attorney for – and brother of – the whistleblower, <a href="https://news.bloomberglaw.com/pharma-and-life-sciences/duke-university-must-return-112-5-million-in-nih-grant-money-1">recognizes the importance of this case, noting</a>, “This case was, simply put, one of the largest scientific fraud cases in history. The impact on the published scientific record, federal grant funding, and on individual researchers was unprecedented.”</p> <p><strong>Duke’s Response</strong></p> <p>The technician behind these falsified reports, Erin Potts-Kant, has also been <a href="https://www.biospace.com/article/falsified-data-forces-duke-to-pay-112-million-settlement-other-universities-under-scrutiny-as-well/">accused of embezzling funds</a> by the University and her employment has been terminated. The allegations of embezzlement occurred during the same time frame as the falsification of data for federal grants. The <em>qui tam </em>case was filed by Thomas after Potts-Kant’s embezzlement actions were discovered by the University, but prior to Duke understanding the full extent of her research misconduct. Duke has also <a href="https://www.dukechronicle.com/article/2019/03/duke-university-settlement-research-fraud-president-price-announces-research-fraud-settlement-with-substantial-payment-to-u-s-government">retracted roughly one dozen scientific publications</a> that relief on data from Potts-Kant’s research.</p> <p>The President of Duke University, Vincent E. Price, has sworn to improve the school’s grant processes, including establishing a panel on research integrity. He also noted that he expects researchers affiliated with the University to adhere to the highest standards of integrity, and <a href="https://today.duke.edu/2019/03/duke-and-us-government-reach-settlement">said</a>, “Virtually all of them do that with great dedication…. When individuals fail to uphold those standards, and those who are aware of possible wrongdoing fail to report it, as happened in this case, we must accept responsibility, acknowledge that our processes for identifying and preventing misconduct did not work, and take steps to improve.”</p> <p><strong>Government Reaction and Statements</strong></p> <p>“Taxpayers expect and deserve that federal grant dollars will be used efficiently and honestly. Individuals and institutions that receive research funding from the federal government must be scrupulous in conducting research for the common good and rigorous in rooting out fraud,” <a href="https://www.justice.gov/opa/pr/duke-university-agrees-pay-us-1125-million-settle-false-claims-act-allegations-related">said Matthew G.T. Martin, United States Attorney for the Middle District of North Carolina</a>. “May this serve as a lesson that the use of false or fabricated data in grant applications or reports is completely unacceptable.”</p> <p>“This settlement sends a strong message that fraud and dishonesty will not be tolerated in the research funding process,” <a href="https://www.justice.gov/opa/pr/duke-university-agrees-pay-us-1125-million-settle-false-claims-act-allegations-related">said EPA Acting Region 4 Administrator Mary S. Walker</a>. “We will continue to take appropriate legal measures to ensure a fiscally sound system that protects grant funds.”</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2019/04/duke-agrees-to-pay-112-5-million-in-false-claims-act-settlement-related-to-scientific-research-misconduct.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>FDA Publishes List of Drug Companies Allegedly Blocking Access to Drug Samples</title> <link>https://www.policymed.com/2018/05/fda-publishes-list-of-drug-companies-allegedly-blocking-access-to-drug-samples.html</link> <comments>https://www.policymed.com/2018/05/fda-publishes-list-of-drug-companies-allegedly-blocking-access-to-drug-samples.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Wed, 30 May 2018 09:12:51 +0000</pubDate> <category><![CDATA[Drug Prices]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[Research]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=10533</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="225" height="225" src="https://www.policymed.com/wp-content/uploads/2018/05/Naughty-List.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/05/Naughty-List.png 225w, https://www.policymed.com/wp-content/uploads/2018/05/Naughty-List-150x150.png 150w" sizes="auto, (max-width: 225px) 100vw, 225px" /></div>The United States Food and Drug Administration (FDA) has recently publicized a list of forty-one branded drug companies that have allegedly blocked access to drug samples in an attempt to obstruct the development of generic drugs. The list includes complaints about branded drug makers improperly using Risk Evaluation and Mitigation Strategy (REMS) requirements to restrict […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="225" height="225" src="https://www.policymed.com/wp-content/uploads/2018/05/Naughty-List.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/05/Naughty-List.png 225w, https://www.policymed.com/wp-content/uploads/2018/05/Naughty-List-150x150.png 150w" sizes="auto, (max-width: 225px) 100vw, 225px" /></div><p>The United States Food and Drug Administration (FDA) has recently publicized a <a href="https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm607738.htm">list of forty-one branded drug companies</a> that have allegedly blocked access to drug samples in an attempt to obstruct the development of generic drugs.</p> <p>The list includes complaints about branded drug makers improperly using Risk Evaluation and Mitigation Strategy (REMS) requirements to restrict access to samples of branded drugs that are necessary to conduct FDA-required tests to demonstrate bioequivalence. In other instances, FDA claims branded drug companies may have placed restrictions in commercial agreements that limit the ability of distributors, wholesalers or specialty pharmacies to sell samples.</p> <p>This announcement comes less than a week after the Trump Administration released a broad drug pricing blueprint, <a href="https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf">American Patients First</a>, and seems to be part of an ongoing effort from FDA Commissioner Scott Gottlieb to spotlight anticompetitive behavior in the prescription drug market.</p> <p>In a <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607930.htm">statement made May 17, 2018</a>, Commissioner Gottlieb noted that the FDA has received over 150 inquiries from generic drug developers seeking assistance in obtaining samples from brand companies. In response, he said the FDA will determine whether these products have in place a REMS program that may impact distribution – a reason frequently cited by the brand companies as the reason behind refusing to provide samples. Commissioner Gottlieb also mentioned that the FDA is notifying the Federal Trade Commission (FTC) about the inquiries and encouraged generic companies to raise their own cases with that Agency, which largely policies anticompetitive behavior.</p> <p>However, as Commissioner Gottlieb noted, even in cases where the FDA confirms there is an existing REMS program with Elements to Assure Safe Use for the brand drug that impacts distribution, generic drug developers should be able to secure samples of the product. To facilitate the transfer of samples in these cases, the FDA has a voluntary process through which generic companies can submit their bioequivalence testing protocols to the agency, and evaluate these protocols to ensure that their plan for testing the product contains safety protections comparable to the brand product’s REMS program. Assuming that the generic drug developers’ plans include appropriate protections, then the generic drug developers can request that the FDA send a letter to the brand company stating that the REMS program does not mean the brand drug maker can’t sell their product to generic drug developers for comparative testing.</p> <p>Samples of the reference listed drug (RLD) – also known as the brand drug – are <a href="https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm607738.htm">important to prospective generic applicants</a> because in order to obtain approval for the generic drug, the generic company must show (in addition to other things) that its version of the product is bioequivalent to the RLD. This usually requires the generic company to conduct bioequivalence studies comparing its product to the RLD, and to retain samples of the RLD used in testing after a study is complete. To conduct these kinds of bioequivalence studies, the generic company needs to obtain samples (generally between 1,500 and 5,000 units) of the RLD.</p> <p>The <a href="https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm607738.htm">list publicized</a> by the FDA reflects the RLD access inquiries FDA has received from prospective generic applicants about marketed RLD products. FDA has also received RLD (or reference product) access inquiries from prospective applicants who intend to submit new drug applications under section 505(b)(2) of the FD&C Act or biologics license applications under section 351(k) of the Public Health Service Act. This webpage, however, is focused on providing transparency about the potential impact of this issue on generic drug market competition.</p> <p>Generic drug makers have been pressing Congress to pass legislation, the “<a href="https://www.congress.gov/bill/115th-congress/senate-bill/974/text">Creating and Restoring Equal Access To Equivalent Samples Act of 2017</a>,” or the “CREATES Act of 2017” (S. 974), that would allow them to sue over these “gaming tactics.” Though it has bipartisan support in both chambers of Congress, it has largely stalled in the face of opposition from branded drug manufacturers.</p> <p>FDA plans to update the list semi-annually.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2018/05/fda-publishes-list-of-drug-companies-allegedly-blocking-access-to-drug-samples.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> </channel> </rss>