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	<title>Drug Shortages &#8211; Policy &amp; Medicine</title>
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		<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>
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					<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" fetchpriority="high" 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 &#8220;This Week in Policy and Medicine,&#8221; 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 [&#8230;]]]></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" 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><p>Welcome to the latest installment of &#8220;<a href="https://open.spotify.com/show/thisweekinpolicyandmedicine">This Week in Policy and Medicine</a>,&#8221; 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 &#8220;<a href="https://open.spotify.com/show/thisweekinpolicyandmedicine">This Week in Policy and Medicine</a>.&#8221; Our coverage provides the insights needed to understand the evolving landscape and how it impacts you. For a deeper dive into these topics, don&#8217;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>
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		<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" 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="(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 [&#8230;]]]></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 &#8220;scientific soundness&#8221; over the draft&#8217;s &#8220;scientifically sound and clinically relevant&#8221; 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&#8217;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>
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		<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 [&#8230;]]]></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&#8217;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&#8217;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 &#8220;Necessary Disruption 2.0&#8221; 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>
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		<title>Minnesota&#8217;s 340B Program Report Sheds Light on Potential Abuses and Sparks Call for Reforms</title>
		<link>https://www.policymed.com/2024/12/minnesotas-340b-program-report-sheds-light-on-potential-abuses-and-sparks-call-for-reforms.html</link>
					<comments>https://www.policymed.com/2024/12/minnesotas-340b-program-report-sheds-light-on-potential-abuses-and-sparks-call-for-reforms.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Mon, 02 Dec 2024 09:04:47 +0000</pubDate>
				<category><![CDATA[Drug Prices]]></category>
		<category><![CDATA[Drug Shortages]]></category>
		<category><![CDATA[HHS]]></category>
		<category><![CDATA[340B ACCESS Act]]></category>
		<category><![CDATA[340B program]]></category>
		<category><![CDATA[charity care]]></category>
		<category><![CDATA[Drug Pricing]]></category>
		<category><![CDATA[for-profit intermediaries]]></category>
		<category><![CDATA[Healthcare Reform]]></category>
		<category><![CDATA[healthcare transparency]]></category>
		<category><![CDATA[legislative reforms]]></category>
		<category><![CDATA[Minnesota Department of Health]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[non-profit hospitals]]></category>
		<category><![CDATA[pharmaceutical profits]]></category>
		<category><![CDATA[policy analysis]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17374</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="618" height="340" src="https://www.policymed.com/wp-content/uploads/2024/11/pharmacy-counter.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/pharmacy-counter.jpg 618w, https://www.policymed.com/wp-content/uploads/2024/11/pharmacy-counter-300x165.jpg 300w" sizes="auto, (max-width: 618px) 100vw, 618px" /></div>The Minnesota Department of Health recently unveiled a pivotal report on the 340B drug pricing program, which provides insight into how the program&#8217;s financial benefits are being utilized by non-profit hospitals and clinics. The 340B program was originally designed to help these facilities purchase medications at significantly reduced prices to support patient care for the [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="618" height="340" src="https://www.policymed.com/wp-content/uploads/2024/11/pharmacy-counter.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/pharmacy-counter.jpg 618w, https://www.policymed.com/wp-content/uploads/2024/11/pharmacy-counter-300x165.jpg 300w" sizes="auto, (max-width: 618px) 100vw, 618px" /></div><p>The Minnesota Department of Health recently unveiled a <a href="https://www.health.state.mn.us/data/340b/docs/2024report.pdf">pivotal report on the 340B drug pricing program</a>, which provides insight into how the program&#8217;s financial benefits are being utilized by non-profit hospitals and clinics. The 340B program was originally designed to help these facilities purchase medications at significantly reduced prices to support patient care for the underserved, the 340B program appears to be exploited for substantial financial gains that do not align with its intended goals.</p>
<p><strong>Background and Implementation of the 340B Program</strong></p>
<p>The 340B program was enacted in 1992 as part of the Public Health Service Act. It was intended to enable non profit healthcare organizations that serve high volumes of low-income patients to extend their federal resources further, enhancing access to affordable medications. Over time, eligibility for the program has expanded to include a variety of health care entities, fostering a broader reach but also complicating oversight and accountability.</p>
<p><strong>Findings from the Minnesota Department of Health Report</strong></p>
<p>The <a href="https://www.health.state.mn.us/data/340b/docs/2024report.pdf">investigation conducted by the Minnesota Department of Health</a> was motivated by growing concerns that some participating entities might be leveraging the pricing benefits for profit rather than improving patient care. Here are the key findings from the report:</p>
<ol>
<li><strong>Profit Generation</strong>: Non-profit hospitals and clinics in Minnesota have reportedly made an estimated $630 million in profits from medications purchased under the 340B program. This figure is considered conservative, given the incomplete data reported by many entities, particularly in the area of provider-administered drugs.</li>
<li><strong>Charity Care and Profit Use</strong>: The report highlights a significant discrepancy between the profits generated from the program and the level of charity care provided. There is concern that these profits are not being used to support care for low-income and uninsured patients, undermining the program&#8217;s foundational objective.</li>
<li><strong>Role of For-Profit Intermediaries</strong>: The involvement of for-profit entities such as pharmacies, Pharmacy Benefit Managers (PBMs), and other intermediaries has diverted approximately $120 million from this safety-net program. This diversion raises serious questions about the program&#8217;s integrity and effectiveness in serving needy communities.</li>
<li><strong>Data Gaps and Reporting Shortcomings</strong>: Many hospitals and clinics failed to report comprehensive data, especially concerning high-cost provider-administered medications. This underreporting prevents a full understanding of the extent of profit generation and the overall impact of the program.</li>
</ol>
<p><strong>Implications and Recommended Reforms</strong></p>
<p>The Minnesota report underscores an urgent need for enhanced transparency and stricter oversight to ensure the 340B program fulfills its original purpose. Recommendations for reform include:</p>
<ul>
<li><strong>Stricter Reporting Requirements</strong>: Implementing more rigorous data submission guidelines to ensure all participating entities provide complete and accurate information.</li>
<li><strong>Reevaluation of Participant Eligibility</strong>: Assessing whether current participants are in alignment with the goals of the 340B program, potentially revising eligibility criteria to prevent abuse.</li>
<li><strong>Directing Benefits to Patient Care</strong>: Ensuring that profits derived from the program are explicitly reinvested into community health and patient care services, particularly for the underserved.</li>
</ul>
<p>The findings from the Minnesota Department of Health are a call to action for policymakers, healthcare providers, and stakeholders to engage in a dialogue about refining the 340B program. With the introduction of legislative reforms such as the <a href="https://www.congress.gov/bill/118th-congress/house-bill/8574/text">340B ACCESS Act,</a> there is an opportunity to restore the program&#8217;s integrity and maximize its benefits for the vulnerable populations it was designed to serve. As this situation unfolds, it is crucial for all involved to prioritize transparency, accountability, and the true spirit of the 340B program.</p>
<p>Additional Resources</p>
<p><a href="https://www.health.state.mn.us/data/340b/docs/2024report.pdf">Minnesota Report to Legislature on 340B program</a></p>
<p><a href="https://www.congress.gov/bill/118th-congress/house-bill/8574/text">340B Access Act</a></p>
<p>&nbsp;</p>
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		<title>Oncology Unscripted with John Marshall, MD: Are You Overdosing Your Patients? Revisiting Dosing Practices</title>
		<link>https://www.policymed.com/2024/11/oncology-unscripted-with-john-marshall-md-are-you-overdosing-your-patients-revisiting-dosing-practices.html</link>
					<comments>https://www.policymed.com/2024/11/oncology-unscripted-with-john-marshall-md-are-you-overdosing-your-patients-revisiting-dosing-practices.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Sat, 16 Nov 2024 09:04:31 +0000</pubDate>
				<category><![CDATA[Clinical Research]]></category>
		<category><![CDATA[Drug Shortages]]></category>
		<category><![CDATA[Editorials]]></category>
		<category><![CDATA[cancer treatment]]></category>
		<category><![CDATA[capecitabine]]></category>
		<category><![CDATA[dosing practices]]></category>
		<category><![CDATA[drug toxicity]]></category>
		<category><![CDATA[Immunotherapy]]></category>
		<category><![CDATA[John Marshall MD]]></category>
		<category><![CDATA[MARIPOSA study]]></category>
		<category><![CDATA[maximum tolerated dose]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[New England Journal of Medicine]]></category>
		<category><![CDATA[Oncology]]></category>
		<category><![CDATA[regorafenib]]></category>
		<category><![CDATA[TKIs]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17327</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1077" height="567" src="https://www.policymed.com/wp-content/uploads/2024/11/john-Marshall-Episode-9.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/john-Marshall-Episode-9.jpg 1077w, https://www.policymed.com/wp-content/uploads/2024/11/john-Marshall-Episode-9-300x158.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/11/john-Marshall-Episode-9-1024x539.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/11/john-Marshall-Episode-9-768x404.jpg 768w" sizes="auto, (max-width: 1077px) 100vw, 1077px" /></div>In the latest episode of Oncology Unscripted, Dr. John Marshall addresses critical issues concerning the dosing practices in oncology, particularly questioning the prevailing approach of using maximum tolerated doses. Dr. Mark Ratain, a distinguished pharmacologist from the University of Chicago, joins the conversation to shed light on how dosing practices can be improved to enhance [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1077" height="567" src="https://www.policymed.com/wp-content/uploads/2024/11/john-Marshall-Episode-9.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/john-Marshall-Episode-9.jpg 1077w, https://www.policymed.com/wp-content/uploads/2024/11/john-Marshall-Episode-9-300x158.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/11/john-Marshall-Episode-9-1024x539.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/11/john-Marshall-Episode-9-768x404.jpg 768w" sizes="auto, (max-width: 1077px) 100vw, 1077px" /></div><p>In the <a href="https://clinicalcaresolutions.net/activities/oncology/video-update9-dr-john-marshall-1/29727-61522/content">latest episode</a> of <a href="https://clinicalcaresolutions.net/content/dr-john-marshall">Oncology Unscripted</a>, Dr. John Marshall addresses critical issues concerning the dosing practices in oncology, particularly questioning the prevailing approach of using maximum tolerated doses. Dr. Mark Ratain, a distinguished pharmacologist from the University of Chicago, joins the conversation to shed light on how dosing practices can be improved to enhance patient outcomes.</p>
<p><strong>Exploring the MARIPOSA Study</strong> Dr. Marshall begins by discussing the findings from the MARIPOSA study featured in the <em>New England Journal of Medicine</em>. This study investigated the combination of amivantamab and lazertinib in treating EGFR-mutated non-small cell lung cancer, comparing it to the standard osimertinib. Although the combination showed a slight improvement in progression-free survival, it was associated with a significant increase in grade three toxicities. Dr. Marshall questions whether the minor benefits justify such an increase in adverse effects, prompting a broader discussion on the need for dose optimization.</p>
<p><strong>Historical Context of Dosing Protocols</strong> Dr. Marshall reflects on the historical reliance on maximum tolerated doses in oncology, a practice rooted in the early days of chemotherapy where more aggressive dosing was equated with better outcomes. He cites instances, such as the treatment of adjuvant breast cancer with bone marrow transplants based on now-debunked studies, to illustrate the dangers of this approach.</p>
<p><strong>In-depth Discussion with Dr. Mark Ratain</strong> Dr. Ratain expands on these concerns, critiquing the ongoing adherence to the &#8220;more is better&#8221; dosing philosophy despite a lack of scientific justification for many cancers. He introduces Project Optimus, an initiative he is involved with, which aims to push for dose optimization in drug development processes endorsed by the FDA. This project seeks to ensure that new drugs are approved at doses that balance efficacy with minimal toxicity.</p>
<p><strong>Challenging Conventional Dosing with Sotorasib as a Case Study</strong> The conversation then shifts to specific examples, such as the recent FDA approval of sotorasib. Dr. Ratain points out that the approved dose was likely higher than necessary, as evidenced by phase studies showing no correlation between higher doses and increased efficacy or plasma concentration. This example highlights the resistance within the pharmaceutical industry and regulatory bodies to reduce doses, often driven by commercial interests.</p>
<p><strong>Advocating for a Paradigm Shift</strong> Both experts advocate for a significant paradigm shift in how doses are determined and prescribed in oncology. They argue for a more patient-centric approach that prioritizes quality of life and long-term health outcomes over outdated dosing paradigms. Dr. Ratain emphasizes the importance of ongoing educational efforts and regulatory support to foster this change.</p>
<p><strong>Conclusion</strong> This episode of Oncology Unscripted not only highlights the urgent need for reevaluation of dosing strategies in cancer treatment but also serves as a call to action for oncologists, regulators, and the pharmaceutical industry to prioritize safer, more effective patient care through scientifically grounded dosing practices.</p>
<p>For more insights and expert discussions, tune in to <a href="https://clinicalcaresolutions.net/content/dr-john-marshall">Oncology Unscripted</a> or visit <a href="http://www.clinicalcaresolutions.net">www.clinicalcaresolutions.net</a>  for extended coverage and expert interviews on the pressing issues in medical dosing today.</p>
<p>&nbsp;</p>
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		<title>HHS Releases White Paper on Drug Shortages, Solutions</title>
		<link>https://www.policymed.com/2024/06/hhs-releases-white-paper-on-drug-shortages-solutions.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Mon, 17 Jun 2024 08:29:47 +0000</pubDate>
				<category><![CDATA[Drug Shortages]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16878</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Recently, the United States Department of Health and Human Services (HHS) issued a white paper, “Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States.” The white paper discusses the impact drug shortages have on patients, caregivers, pharmacies, hospitals, nursing homes, and other entities across the health system. HHS states [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/06/stencil.default-2023-06-30T185545.495-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Recently, the United States Department of Health and Human Services (HHS) issued a white paper, “<a href="https://aspe.hhs.gov/sites/default/files/documents/3a9df8acf50e7fda2e443f025d51d038/HHS-White-Paper-Preventing-Shortages-Supply-Chain-Vulnerabilities.pdf">Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States</a>.” The white paper discusses the impact drug shortages have on patients, caregivers, pharmacies, hospitals, nursing homes, and other entities across the health system.</p>
<p>HHS states that drug shortages are often caused by a lack of transparency, concentration among middlemen, and prices for generic drugs that are so low that they create insufficient incentives for resilience-oriented manufacturing, distribution, and purchasing. To help solve the problem of drug shortages, HHS has established a new Supply Chain Resilience and Shortage Coordinator role to strengthen the agency’s coordination and implementation of strategies to enhance supply chain resilience for all medical products. In addition, the Food and Drug Administration (FDA) is working to develop a framework that would evaluate Quality Management Maturity (QMM) at drug manufacturing establishments, which would help to gauge adoption of management practices that support a more reliable drug supply chain by both reducing the occurrence of quality-related failures and improving the ability of drug manufacturers to maintain performance during expected and unexpected supply chain disruptions.</p>
<p>HHS notes that while the agency has made progress in shoring up the system’s ability to respond to shortages, additional solutions “require additional statutory authorities and funding to resolve underlying causes of shortages.” The paper, therefore, attempts to outline policy concepts for consideration, including collaboration with the private sector to develop and implement a Manufacturer Resiliency Assessment Program (MRAP) and a Hospital Resilient Supply Program (HRSP).</p>
<p>The HRSP is a system that would connect Medicare payments to hospitals’ drug supply actions related to inventory management and contracting practices. It could include both incentive payments and penalties based on a hospital’s adherence to best practices for preventing shortages. The MRAP would be a public-private partnership that would hold drug manufacturers to benchmarks and metrics for manufacturing resilience, such as redundancies and product quality management. Manufacturers that meet the standards would receive recognition from HHS.</p>
<p>According to the white paper, the MRAP and HRSP could be implemented in stages as a long-term approach, starting with hospitals that provide inpatient services for certain types of drugs. MRAP implementation could begin by developing manufacturer resilience assessment metrics for an initial set of drugs, such as the drugs in ASPR’s list of critical medicines. HRSP could develop and apply payment incentives and/or penalties in multiple ways, such as: (1) apply penalties and incentives simultaneously; (2) introduce penalties first and then incentives; or (3) introduce incentives first and then penalties. HHS estimates the cost of implementing MRAP and HRSP would be between $3.26 billion and $5.11 billion, though the exact amount would vary depending on policy choices.</p>
<p>HHS believes that the concepts outlined in the white paper would help to make the market more transparent, link purchasing and payment decisions to supply chain resilience practices, and incentivize investments in supply chain resilience and diversification in the supply chain—including domestic manufacturing—at a scale that would drive impactful change in the market.</p>
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		<title>Colorado Working to Be Second State to Import Drugs from Canada</title>
		<link>https://www.policymed.com/2024/05/colorado-working-to-be-second-state-to-import-drugs-from-canada.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 21 May 2024 08:35:21 +0000</pubDate>
				<category><![CDATA[Drug Prices]]></category>
		<category><![CDATA[Drug Shortages]]></category>
		<category><![CDATA[State Policy]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16822</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869.jpg 1200w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Colorado’s General Assembly passed a law in 2019 that allowed the Colorado Department of Health Care Policy and Financing (HCPF) to develop a Canadian prescription drug importation program. In March 2020, Colorado submitted a program proposal and detailed comments in response to the December 2019 federal Health and Human Services (HHS) Notice of Proposed Rulemaking [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869.jpg 1200w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p class="MsoNormal">Colorado’s General Assembly <a href="https://leg.colorado.gov/bills/sb19-005">passed a law in 2019</a> that allowed the Colorado Department of Health Care Policy and Financing (HCPF) to develop a Canadian prescription drug importation program. In March 2020, Colorado submitted a program proposal and detailed comments in response to the December 2019 federal Health and Human Services (HHS) Notice of Proposed Rulemaking (NPRM)/draft rule.</p>
<p class="MsoNormal">The HHS final rule went into effect in November 2020, implementing a federal regulatory framework that directs how to develop and operate an Importation Program. In January 2021, HCPF sought vendors for the program and issued an Invitation to Negotiate, seeking vendors for the program. The ITN closed in April 2021 and HCPF started negotiations with supply chain partners and identified program consultants and certifiers to ensure compliant program development. Program partners were announced in August 2022 and on December 5, 2022, HCPF submitted the <a href="chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/hcpf.colorado.gov/sites/hcpf/files/Colorado%27s%20Drug%20Importation%20Program%202022%20Formal%20SIP.pdf">Section 804 Importation Program (SIP) application</a> to the Food and Drug Administration (FDA) for review and approval. In response to an FDA Request for Information, HCPF <a href="chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/hcpf.colorado.gov/sites/hcpf/files/Colorado%20Section%20804%20SIP%20Application%20Amended%202.27.24.pdf">amended the SIP application on February 27, 2024</a>, and <a href="https://hcpf.colorado.gov/drug-importation">currently estimates</a> that the Colorado Importation Program will be approved in 2024.<span style="mso-spacerun: yes;"> </span></p>
<p class="MsoNormal">According to a <a href="https://hcpf.colorado.gov/sites/hcpf/files/HCPF%20Drug%20Importation%20Annual%20Report%202023.pdf">report issued by Colorado in 2023</a>, the state said it was having difficulty with “securing drug supply for the program, drug manufacturer resistance, and regulatory ambiguity.” Additionally, the report states that of twenty-three drug companies, nine companies refused participation in Colorado’s drug importation program and four agreed to meet but said they would not participate in the program. The other ten companies did not respond to requests to meet, despite multiple attempts.</p>
<p class="MsoNormal">In that report, it was also noted that “[b]ecause drug manufacturers in Canada have contract terms with wholesalers, including any FDA-required foreign seller, that prohibit the exportation of drugs to the U.S., Colorado is unable to secure drug supply absent direct negotiation, and ultimately a contractual agreement, with manufacturers.”</p>
<p class="MsoNormal">Colorado turned to the FDA for help with the number of refusals, and the FDA said it is not mandatory that the agency help compel manufacturers to sell drugs that are intended for the Canadian market to the United States. Kim Bimestefer, executive director of the Colorado Department of Health Care Policy &amp; Financing, <a href="https://kffhealthnews.org/news/article/health-202-colorado-drug-importation/">said</a> that the state still hopes for the FDA’s help, “While we continue to reach out to manufacturers to ask them to do the right thing for consumers, employers and taxpayers, we are also working with the FDA for additional guidance on how to best navigate sourcing drugs.”</p>
<p class="MsoNormal">The FDA also reinforced its willingness to “continue to work with states and Indian tribes” to develop their individual importation programs <a href="https://kffhealthnews.org/news/article/health-202-colorado-drug-importation/">through a statement</a> by FDA spokesperson Jeremy Kahn.</p>
<p class="MsoNormal"><b>Florida Still Seemingly at a Standstill</b></p>
<p class="MsoNormal">For what it’s worth, Florida is still having difficulty in importing drugs from Canada, with Brock Juarez, a spokesperson for the Florida Agency for Health Care Administration, <a href="https://kffhealthnews.org/news/article/health-202-colorado-drug-importation/">saying</a>, “Our vendor is establishing relationships with drug manufacturers and working on negotiating agreements.”</p>
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		<title>Drug Shortages Continue to Worsen</title>
		<link>https://www.policymed.com/2023/07/drug-shortages-continue-to-worsen.html</link>
					<comments>https://www.policymed.com/2023/07/drug-shortages-continue-to-worsen.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 21 Jul 2023 08:28:10 +0000</pubDate>
				<category><![CDATA[Drug Shortages]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16168</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Shortages of life-saving drugs, including cancer drugs, have been in the news in recent months. The United States House of Representatives held a hearing about the root causes of the drug shortages, including the “race to the bottom” in drug pricing that tends to negatively impact investment in manufacturing and can lead to fewer companies [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/06/stencil.default-25-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Shortages of life-saving drugs, <a href="https://pressroom.cancer.org/releases?item=1217">including cancer drugs</a>, have been in the news in recent months. The United States House of Representatives <a href="https://energycommerce.house.gov/events/oversight-and-investigations-subcommittee-hearing-examining-the-root-causes-of-drug-shortages-challenges-in-pharmaceutical-drug-supply-chains">held a hearing</a> about the root causes of the drug shortages, including the “race to the bottom” in drug pricing that tends to negatively impact investment in manufacturing and can lead to fewer companies actively producing individual drugs.</p>
<p>According to the American Society for Health-System Pharmacists, there are <a href="https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?page=CurrentShortages&amp;sort=3">more than 230 drugs currently experiencing</a> a shortage. Cancer treatments, heart medications, albuterol inhalers, amoxicillin, and penicillin are among the drugs that are currently in a shortage or were recently experiencing a shortage.</p>
<p>During the House hearing, it was discussed that at the root of the issue, drug shortages are caused by economic factors. Generic drugs tend to have low to no profit margins because of the low prices that intermediaries who buy or negotiate drug prices can get from the manufacturers. Whether those price savings are passed on to patients is a contested area.</p>
<p>Drug manufacturers, including <a href="https://www.bloomberg.com/news/articles/2023-05-18/teva-plans-cuts-to-generic-drug-production-amid-shortages?leadSource=uverify%20wall#xj4y7vzkg">Teva Pharmaceuticals</a> and <a href="https://www.nytimes.com/2023/05/17/health/drug-shortages-cancer.html?campaign_id=9&amp;emc=edit_nn_20230518&amp;instance_id=92852&amp;nl=the-morning&amp;regi_id=184185478&amp;segment_id=133236&amp;te=1&amp;user_id=1d7e6d06a96090be67424919b110b152">Akorn Pharmaceuticals</a>, have either scaled back or completely closed the generic component of business, in part due to low profitability. Teva was previously one of the largest generic drug manufacturers in the world, but notes that with debt increasing and prices decreasing, it was no longer viable for them to produce generics at such a high volume. Akorn filed for Chapter 7 bankruptcy, which led to a recall of its products and shortages in medications such as albuterol. As of April 2023, four drugs manufactured by Akorn were <a href="https://www.beckershospitalreview.com/pharmacy/akorn-from-financial-troubles-to-a-shutdown-and-intensifying-drug-shortages.html">discontinued</a>, while another 14 were experiencing severe shortages.</p>
<p>Scott Gottlieb, former Food and Drug Administration (FDA) Commissioner and a board member at Pfizer <a href="https://www.cbsnews.com/video/extended-interview-dr-scott-gottlieb-on-face-the-nation-may-21-2023/#x">noted that</a> the “generic business, particularly for these complex drugs, these complex formulations, is not a health business right now.” He went on to say that while there are some ‘things the government can do…most of them are going to cost money” and that it’s likely that there needs to be “ways to provide more reimbursement for these hard-to-manufacture drugs.” Gottlieb also referred to the Inflation Reduction Act, noting that it may be contributing to the lack of investment in the generic supply chain.</p>
<p><strong>What is the Solution?</strong></p>
<p>While Gottlieb noted that the government can step in and help alleviate some of the shortages, it remains to be seen if and how that will be done. The White House has <a href="https://www.bloomberg.com/news/articles/2023-05-10/drug-shortages-quality-woes-get-secret-white-house-attention?leadSource=uverify%20wall#xj4y7vzkg">a team assembled</a> of professionals who are focused on the shortages and quality issues in the supply chain, and the House of Representatives has held a hearing on the issue.</p>
<p>During the hearing Representative Cathy McMorris-Rodgers <a href="https://energycommerce.house.gov/posts/chair-rodgers-on-drug-shortages-we-must-ensure-people-can-find-lifesaving-care-and-medicines">raised ideas</a> such as increasing the reimbursement rates for generics and reviewing the business practices of pharmacy benefit managers. She also referred to the “harmful consequences of consolidation, federal programs, and malincentives that distort the market and make it more difficult for patients to get lower cost medication” and called for “American innovation, [an] increase [in] domestic manufacturing capabilities, and …the adoption of quality generic drugs.” Representative Frank Pallone suggested that we need greater transparency surrounding drug ingredients made overseas and expanded reporting on unexpected spikes in drug demands.</p>
<p>However, no solutions have yet been put forth in an official manner.</p>
<p><strong>It&#8217;s Not Just Generics</strong></p>
<p>While the generic shortages may be a result of pricing pressures, brand-name drugs are also experiencing shortages, <a href="https://www.nationwidechildrens.org/family-resources-education/700childrens/2023/01/tylenol-shortage">including Children’s Tylenol</a> during the winter months. This was likely due to the uptick in a combination of flu, RSV, and COVID cases.</p>
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		<title>California Getting into the Generic Drug Business?</title>
		<link>https://www.policymed.com/2020/09/california-getting-into-the-generic-drug-business.html</link>
					<comments>https://www.policymed.com/2020/09/california-getting-into-the-generic-drug-business.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 18 Sep 2020 09:01:47 +0000</pubDate>
				<category><![CDATA[Drug Prices]]></category>
		<category><![CDATA[Drug Shortages]]></category>
		<category><![CDATA[State Policy]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=13824</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13.jpg 1200w, https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Earlier this month, California’s state legislature approved a bill that would allow the state to be the first state to develop its own line of generic drugs, putting it in direct competition with larger drug manufacturers.   The bill would require the California Health and Human Services Agency (CHHSA) to enter into partnerships with other state departments as necessary to, [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13.jpg 1200w, https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2020/09/stencil.default-13-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p><span data-contrast="auto">Earlier this month, California’s state legislature </span><a href="https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200SB852"><span data-contrast="none">approved a bill</span></a><span data-contrast="auto"> that would allow the state to be the first state to develop its own line of generic drugs, putting it in direct competition with larger drug manufacturers. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><span data-contrast="auto">The bill </span><a href="https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200SB852"><span data-contrast="none">would require</span></a><span data-contrast="auto"> the California Health and Human Services Agency (CHHSA) to enter into partnerships with other state departments as necessary to, among other things, increase patient access to affordable drugs. The bill would require CHHSA to enter into partnerships to produce or distribute generic prescription drugs (including at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in savings). </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><span data-contrast="auto">The bill would require </span><a href="https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200SB852"><span data-contrast="none">CHHSA to report to the Legislature</span></a><span data-contrast="auto"> a description of the status of the drugs targeted for manufacture and an analysis of how CHHSA’s activities have impacted competition, access, and costs for those drugs by July 1, 2022. Then, CHHSA would have to submit a report to the Legislature on or before July 1, 2023, that assesses the feasibility and advantages of directly manufacturing generic prescription drugs and selling generic prescription drugs at a fair price. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><span data-contrast="auto">Interestingly, the bill would </span><a href="https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200SB852"><span data-contrast="none">exempt all nonpublic information and documents</span></a><span data-contrast="auto"> relating to this program from disclosure under the California Public Records Act in order to protect proprietary, confidential information regarding manufacturer or distribution costs and drug pricing, utilization, and rebates.</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><span data-contrast="auto">While the bill doesn’t outline many specifics, as noted above, the one specific is that it </span><a href="https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201920200SB852"><span data-contrast="none">would require the state</span></a><span data-contrast="auto"> to make “at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in savings.” No other mandates were included in the legislation as far as other drugs that must be made. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><span data-contrast="auto">The legislature may be intending for the state to follow a model previously announced by </span><a href="https://civicarx.org/about/"><span data-contrast="none">Civica Rx</span></a><span data-contrast="auto">, which was initially supposed to be that of a generic drug manufacturer, but after evaluating the United States Food and Drug Administration (FDA) Abbreviated New Drug Application (ANDA) process, Civica Rx tries to purchase expiring ANDAs from generic manufacturers and is now more of a contract drug purchaser, more in line with a group purchasing organization. Now, two years after Civica’s announcement, they are up to </span><a href="https://www.forbes.com/sites/brucejapsen/2020/09/02/nonprofit-drug-maker-civica-rx-eclipses-1200-us-hospital-members/#420067de1ea5"><span data-contrast="none">partnerships with more than 1,200 hospitals</span></a><span data-contrast="auto"> around the United States. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><span data-contrast="auto">This would be quite expensive for the state to do, as the state’s </span><a href="https://leginfo.legislature.ca.gov/faces/billAnalysisClient.xhtml?bill_id=201920200SB852"><span data-contrast="none">fiscal analysis</span></a><span data-contrast="auto"> puts the estimate between $1 million and $2 million, in addition to staff costs. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
<p><span data-contrast="auto">While Governor Gavin Newsome has until September 30, 2020, to either sign or veto the measure, even if he signs it, it is likely that it will take years for California to successfully bring products to market. </span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}"> </span></p>
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		<title>Trump Signs Executive Order Regarding Medical Supply Chain</title>
		<link>https://www.policymed.com/2020/09/trump-signs-executive-order-regarding-medical-supply-chain.html</link>
					<comments>https://www.policymed.com/2020/09/trump-signs-executive-order-regarding-medical-supply-chain.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 01 Sep 2020 09:02:05 +0000</pubDate>
				<category><![CDATA[Drug Shortages]]></category>
		<category><![CDATA[Executive Branch]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=13770</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3.jpg 1200w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>On August 6, 2020, President Donald Trump issued an executive order (EO) aimed at the medical supply chain in America. The EO, Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States, aims to increase our domestic manufacturing and onshoring supply chains for pharmaceutical and medical supplies, to [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3.jpg 1200w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-3-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>On August 6, 2020, President Donald Trump issued an executive order (EO) aimed at the medical supply chain in America. The EO, <a href="https://www.whitehouse.gov/presidential-actions/executive-order-ensuring-essential-medicines-medical-countermeasures-critical-inputs-made-united-states/">Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States</a>, aims to increase our domestic manufacturing and onshoring supply chains for pharmaceutical and medical supplies, to get out in front of any potential shortages. To do that, the EO requires federal agencies to purchase “essential” pharmaceuticals and medical supplies from domestic manufacturers and directs the Food and Drug Administration (FDA) to speed up domestic approvals of essential medical products, as well as identify supply chain vulnerability and target counterfeit drug and medical supply imports. The Environmental Protection Agency (EPA) was also assigned a task, streamlining requirements around the continuous manufacturing and speeding up siting and permitting approvals.</p>
<p>While several government agencies (including the Department of Health and Human Services (HHS), Veterans Affairs, and the Department of Defense) have been directed to purchase “essential drugs and medical supplies” solely from American manufacturers, which drugs and supplies are considered “essential” has not been defined. Instead, the FDA was directed to create a list of drugs and medical supplies subject to the requirement. The EO also includes relatively broad exemptions based on cost, availability, and “public interest.”</p>
<p>The <a href="https://www.whitehouse.gov/presidential-actions/executive-order-ensuring-essential-medicines-medical-countermeasures-critical-inputs-made-united-states/">EO is not a substitute for an appropriations bill</a> and the White House will not be making new investments or pushing for tax incentives to encourage the onshoring of the medical supply chain. Instead, the EO is aimed at establishing government demand for domestically made products and encouraging innovative manufacturing technologies that are needed to keep drug prices low.</p>
<p>With respect to <a href="https://www.whitehouse.gov/presidential-actions/executive-order-ensuring-essential-medicines-medical-countermeasures-critical-inputs-made-united-states/">maximizing domestic procurement</a>, within 90 days, FDA and heads of other federal agencies will develop and implement procurement strategies, including long-term contracts, to increase domestic manufacturing for these goods. Additionally, no later than 30 days after the FDA establishes a list of essential medicines and medical countermeasures, the U.S. Trade Representative will take all “appropriate action” to modify U.S. procurement product coverage under all relevant free trade agreements and World Trade Organization Agreement on Government Procurement to exclude coverage of essential medicines and medical countermeasures. Then, no later than 60 days after the FDA has established a list of essential medicines and medical countermeasures, the Secretary of Defense will restrict procurement to domestic sources and reject other offers of such products from qualifying countries where necessary for national defense.</p>
<p>When it comes to current vulnerabilities in the supply chain, within 180 days, the HHS secretary, FDA and Office of Management and Budget (OMB) <a href="https://www.whitehouse.gov/presidential-actions/executive-order-ensuring-essential-medicines-medical-countermeasures-critical-inputs-made-united-states/">will</a> identify vulnerabilities in the supply chain for essential medicines and medical countermeasures. HHS and FDA have been expected to accelerate approval or clearance for domestic producers of essential medicines and medical countermeasures, issue guidance with recommendations on the development of advanced manufacturing techniques,  negotiate with countries to increase site inspections increase the number of unannounced inspections of regulated facilities, and reject imports of essential medicines and medical countermeasures if the facilities in which they are produced refuse or unreasonably delay inspection.</p>
<p>The <a href="https://www.whitehouse.gov/presidential-actions/executive-order-ensuring-essential-medicines-medical-countermeasures-critical-inputs-made-united-states/">EO also directs</a> that within 180 days, the Secretary of Defense and OMB will identify vulnerabilities in the supply chain, and provide HHS, FDA, OMB, and the Director of the Office of Trade and Manufacturing Policy a list of defense-specific essential medicines and medical countermeasures that are medically necessary to have available for defense use in adequate amounts and in appropriate dosage forms. The list is to be updated periodically.</p>
<p>The <a href="https://www.whitehouse.gov/presidential-actions/executive-order-ensuring-essential-medicines-medical-countermeasures-critical-inputs-made-united-states/">EO also includes a reporting requirement</a> that requires the head of each federal agency to provide a publicly-available report to the president by December 15, 2021 that outlines the following items for the preceding three fiscal years:</p>
<p style="padding-left: 40px;">(1) the essential medicines, medical countermeasures, and critical inputs procured by the agency;</p>
<p style="padding-left: 40px;">(2) the agency’s itemized and aggregated expenditures for these products;</p>
<p style="padding-left: 40px;">(3) the source of the products; and</p>
<p style="padding-left: 40px;">(4) the agency’s plan to support domestic production of the products in the next fiscal year.</p>
<p>While this EO has been expected for several months, it was held up by legal review. Now that it has been issued, the agencies can begin to work on the tasks assigned to them.</p>
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