<?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>REMS – Policy & Medicine</title> <atom:link href="https://www.policymed.com/category/rems/feed" rel="self" type="application/rss+xml" /> <link>https://www.policymed.com</link> <description>Legal, Regulatory, and Compliance Issues</description> <lastBuildDate>Sat, 30 Sep 2023 00:24:18 +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>REMS – Policy & Medicine</title> <link>https://www.policymed.com</link> <width>32</width> <height>32</height> </image> <item> <title>Concerns Over Changes to Third-Party Vendors for REMS Systems</title> <link>https://www.policymed.com/2023/11/concerns-over-changes-to-third-party-vendors-for-rems-systems.html</link> <comments>https://www.policymed.com/2023/11/concerns-over-changes-to-third-party-vendors-for-rems-systems.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Fri, 03 Nov 2023 08:45:53 +0000</pubDate> <category><![CDATA[REMS]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=16351</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" fetchpriority="high" 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="(max-width: 1200px) 100vw, 1200px" /></div>Earlier this year, the United States Food and Drug Administration (FDA) published a Federal Register notice requesting comments on changes to third-party vendors for Risk Evaluation and Mitigation Strategies (REMS) systems, in compliance with the Consolidated Appropriations Act of 2023. While the comment period ended in July 2023, many of the comments that came in […]]]></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" 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="(max-width: 1200px) 100vw, 1200px" /></div><p>Earlier this year, the United States Food and Drug Administration (FDA) published a <a href="https://www.regulations.gov/document/FDA-2023-N-0573-0002">Federal Register notice</a> requesting comments on changes to third-party vendors for Risk Evaluation and Mitigation Strategies (REMS) systems, in compliance with the Consolidated Appropriations Act of 2023. While the comment period ended in July 2023, many of the comments that came in asked the FDA to take a flexible approach when reviewing changes, arguing that a restrictive approach could limit patient access to important and life-saving drugs.</p> <p>While some comments did include support for more oversight by the agency, many included the belief that no two REMS systems (or REMS administrators) are alike. Therefore, many comments highlighted the need for flexibility when assessing changes to REMS vendors and to look at each REMS system on an individual basis.</p> <p>Commenters shared concerns about the impact of changes to REMS systems on patient access, especially in light of changes to the iPLEDGE REMS system for isotretinoin and the REMS program for clozapine, both of which caused disruptions to patient access. Ultimately, in each of those instances, the FDA did exercise enforcement discretion to ease the REMS requirements to improve access, but market factors continue to cause disruptions, including REMS administrators leaving the field.</p> <p>For example, the <a href="https://www.regulations.gov/comment/FDA-2023-N-0573-0026">REMS Industry Consortium</a> said that drugmakers participating in REMS are already facing challenges in patient access to drugs, including some essential drugs that are subject to shortages. In its comment, the Consortium noted “It cannot be overemphasized that flexibility remains paramount in REMS program development and management, and the need for flexibility and ‘right-sizing’ an approach applies across the entire REMS system – from stakeholder feedback to pre-launch testing to timelines and metrics to measure success.”</p> <p>The <a href="https://www.regulations.gov/comment/FDA-2023-N-0573-0017">Association for Accessible Medicine</a> echoed those comments, saying, “Changing a REMS vendor is complicated and costly and has important implications for the long-term marketability of drug products covered by the REMS. REMS vendors are selected with care from a limited pool of potential vendors, and that pool is shrinking as vendors have consolidated or left the market.” The comment went on to note that, “The shrinking pool of vendors able to provide the necessary services can increase the costs for REMS participants, and for small generic companies these costs can be prohibitive, causing some to exit the market or withdraw pending abbreviated new drug applications (ANDA), ultimately compromising patient access to medicines.”</p> <p>Pharmaceutical company <a href="https://www.regulations.gov/comment/FDA-2023-N-0573-0010">GSK</a> also submitted comments, where the company said, “”Early in the REMS development process, the REMS sponsor(s) should consult with impacted distribution channel entities (e.g. distributors, specialty pharmacies, retail pharmacies), healthcare systems, patient advocacy groups, prescribers, and health professional organizations to proactively identify possible challenges and barriers as well as ideal implementation timelines.”</p> <p>Comments also included responses to how much time stakeholders need to transition from one REMS system to another, varying from just a few months to a year.</p> <p>The <a href="https://www.regulations.gov/comment/FDA-2023-N-0573-0014">American Academy of Dermatology Association</a> believes that REMS administrators and drug sponsors should have at least 12 months so they can run a pilot test of a new REMS system before fully rolling it out. The <a href="https://www.regulations.gov/comment/FDA-2023-N-0573-0025">Healthcare Distribution Alliance</a>, on the other hand, noted that a minimum of 90 days should be provided so that significant changes can be effectively implemented into an existing REMS program.</p> <p>All comments can be viewed <a href="https://www.regulations.gov/docket/FDA-2023-N-0573/comments">here</a>.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2023/11/concerns-over-changes-to-third-party-vendors-for-rems-systems.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>FDA Requests Comments on Potential Modification to Opioid Analgesic Risk Evaluation and Mitigation Strategy</title> <link>https://www.policymed.com/2022/04/fda-requests-comments-on-potential-modification-to-opioid-analgesic-risk-evaluation-and-mitigation-strategy.html</link> <comments>https://www.policymed.com/2022/04/fda-requests-comments-on-potential-modification-to-opioid-analgesic-risk-evaluation-and-mitigation-strategy.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Mon, 25 Apr 2022 08:00:14 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[Opioids]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=15163</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="645" height="363" src="https://www.policymed.com/wp-content/uploads/2020/03/fda496532228.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2020/03/fda496532228.jpg 645w, https://www.policymed.com/wp-content/uploads/2020/03/fda496532228-300x169.jpg 300w" sizes="(max-width: 645px) 100vw, 645px" /></div>On April 21, 2022, the United States Food and Drug Administration (FDA) filed a Notice and Request for Comment regarding a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that mail-back envelopes be dispensed and education on safe disposal provided with opioid analgesics dispensed in an outpatient setting. […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="645" height="363" src="https://www.policymed.com/wp-content/uploads/2020/03/fda496532228.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/03/fda496532228.jpg 645w, https://www.policymed.com/wp-content/uploads/2020/03/fda496532228-300x169.jpg 300w" sizes="auto, (max-width: 645px) 100vw, 645px" /></div><p>On April 21, 2022, the United States Food and Drug Administration (FDA) <a href="https://public-inspection.federalregister.gov/2022-08372.pdf">filed a Notice and Request for Comment</a> regarding a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that mail-back envelopes be dispensed and education on safe disposal provided with opioid analgesics dispensed in an outpatient setting. FDA believes that such a requirement might “reduce the amount of unused opioid analgesics in patients’ homes, thereby reducing opportunities for nonmedical use, accidental exposure, and overdose, and possibly reducing the development of new opioid addiction.”</p> <p>The <a href="https://public-inspection.federalregister.gov/2022-08372.pdf">Notice states</a> that while the volume of prescription opioid analgesics dispensed has been trending downward since 2012, there were still an estimated 140.6 million prescriptions, resulting in an estimated 8.7 billion units (e.g., tablets or capsules) dispensed in 2021 from U.S. outpatient retail and mail order pharmacies. Additionally, despite the decline in opioid dispensing, as of 2020, prescription opioids were involved in more than 16,000 fatal overdoses per year, higher than the number seen at the peak of opioid analgesic dispensing in 2012.</p> <p>The FDA <a href="https://public-inspection.federalregister.gov/2022-08372.pdf">notes</a> that patients frequently report having unused opioid analgesics after treatment of acute pain, such as pain following surgical procedures. Opioid analgesics prescribed to treat chronic pain conditions can also result in unused drugs. When not properly disposed, these “extra” opioid analgesics provide opportunities for nonmedical use, accidental exposure, and overdose. Most of those who reported non-medically approved use of prescription pain relievers obtained them through friends, relatives, or their own prescription. Therefore, FDA’s efforts to address the opioid crisis include a focus on encouraging appropriate disposal of unused opioid analgesics.</p> <p>As noted above, the FDA is <a href="https://public-inspection.federalregister.gov/2022-08372.pdf">currently investigating</a> whether mail-back envelopes and education on safe disposal would help alleviate the opioid crisis. FDA notes that this is just “one possible application of FDA’s new authorities” in the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to packaging and disposal and that if there are other possible applications of these applications – including novel packaging or other safe disposal options that would meet standards found in the SUPPORT Act.</p> <p>FDA <a href="https://public-inspection.federalregister.gov/2022-08372.pdf">also noted</a> in the Notice that it is “actively encourag[ing]” drug manufacturers to innovate in this space and that the Agency does recognize that there are organizations (public and private) that have ongoing efforts to increase the safe disposal of opioids. To that end, the Agency believes that it is important for patients to have a variety of options when it comes to disposing of unused opioids, including kiosks, take-back events, and in-home disposal options.</p> <p>While FDA seems to be a proponent of the mail-back envelope REMS, the Agency is seeking comments for and against the idea, and already <a href="https://public-inspection.federalregister.gov/2022-08372.pdf">recognizes that there are some potential burdens</a> placed on pharmacists and pharmacies with the mail-back envelope REMS requirement, including possibly: (1) completion of any REMS-mandated training and certification; (2) implementation of REMS-compliant processes in pharmacies; and (3) documentation of compliance with REMS requirements by pharmacies.</p> <p><strong>Comments Requested</strong></p> <p>FDA is soliciting comments from stakeholders regarding all aspects of the potential mail-back envelope REMS mandate described in this document.</p> <p>Some of the <a href="https://public-inspection.federalregister.gov/2022-08372.pdf">specific topics</a> FDA is interested in hearing about include:</p> <ol> <li>The potential safety advantages and public health impacts of providing mail-back envelopes with opioid analgesics dispensed in an outpatient setting.</li> <li>Whether there are specific opioid analgesic drug products for which requiring mailback envelopes is more important from a public health perspective and, if so, which products.</li> <li>How pharmacies could identify those patients who are most likely to have unused opioids to optimize provision of mail-back envelopes to these patients and potentially positively impact the share of mail-back envelopes that are utilized to safely dispose of opioid analgesics.</li> <li>How pharmacies could develop and implement algorithms to determine when to provide a mail-back envelope, including how feasible or practical it would be for pharmacies to do so.</li> <li>What key educational messages regarding secure storage and safe disposal should be included in any patient education component of the potential OA REMS requirement described in this notice, including educational messages to increase uptake and use of mail-back envelopes, as well as what form that education should take (e.g., handouts, pharmacist counseling of patients).</li> <li>Any existing programs that provide mail-back envelopes, especially programs that provide patient counseling on disposal and that operate in retail pharmacies, including any data on the effectiveness of these programs.</li> <li>Other actions FDA could take in addition to, and in support of, a mail-back envelope disposal REMS requirement to increase safe disposal of unused opioid analgesics.</li> </ol> <p>If you would like to submit comments, you can submit written or electronic comments by June 20, 2022.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2022/04/fda-requests-comments-on-potential-modification-to-opioid-analgesic-risk-evaluation-and-mitigation-strategy.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>CME/CNE/CPE Medical Education Program Helps Physicians Integrate the FDA Mycophenolate Safety Standards to Prevent Potential Birth Defects</title> <link>https://www.policymed.com/2021/11/cme-cne-cpe-medical-education-program-helps-physicians-integrate-the-fda-mycophenolate-safety-standards-to-prevent-potential-birth-defects.html</link> <comments>https://www.policymed.com/2021/11/cme-cne-cpe-medical-education-program-helps-physicians-integrate-the-fda-mycophenolate-safety-standards-to-prevent-potential-birth-defects.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Sat, 06 Nov 2021 08:49:04 +0000</pubDate> <category><![CDATA[CME]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=14774</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="1318" height="381" src="https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems.jpg 1318w, https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems-300x87.jpg 300w, https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems-1024x296.jpg 1024w, https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems-768x222.jpg 768w" sizes="auto, (max-width: 1318px) 100vw, 1318px" /></div>Leading continuing medical education provider, Rockpointe, in conjunction with Boston University and Potomac Center for Medical Education is offering webinars and an on-demand web course on mycophenolate safety standards to help prevent birth defects when prescribing mycophenolic acid (MPA) products, including mycophenolate mofetil (MMF) (CellCept) and enteric-coated mycophenolate sodium (Myfortic). This continuing medical education program […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1318" height="381" src="https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems.jpg 1318w, https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems-300x87.jpg 300w, https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems-1024x296.jpg 1024w, https://www.policymed.com/wp-content/uploads/2021/11/Mycrorems-768x222.jpg 768w" sizes="auto, (max-width: 1318px) 100vw, 1318px" /></div><p>Leading continuing medical education provider, Rockpointe, in conjunction with Boston University and Potomac Center for Medical Education is offering <a href="https://cme.rockpointe.com/1097-mycophenolate-safety-standards-to-prevent-adverse-pregnancy-outcomes-coverys">webinars and an on-demand web course</a> on mycophenolate safety standards to help prevent birth defects when prescribing mycophenolic acid (MPA) products, including mycophenolate mofetil (MMF) (CellCept) and enteric-coated mycophenolate sodium (Myfortic). This<a href="https://www.rockpointe.com/courses/integrating-the-fda-mycophenolate-safety-standards-to-prevent-adverse-pregnancy-outcomes/"> continuing medical education program</a> is offered at no cost to all clinicians who prescribe mycophenolates.</p> <p>Mycophenolates were approved by the FDA in 1995 and 2004 as immunosuppressants used in preventing rejection of transplanted organs. MPA has become a front-line anti-rejection therapy in combination with calcineurin-inhibitors and corticosteroids. Mycophenolates are also widely used in the treatment of a wide range of autoimmune conditions such as lupus, rheumatoid arthritis, and multiple sclerosis.</p> <p>However, use of MPA during pregnancy is associated with a significant increased risk of pregnancy loss, congenital malformations, and low birth weight. The FDA approved the Mycophenolate Shared System Risk Evaluation and Mitigation Strategy (MREMS) in 2012, but despite the information provided to clinicians and patients on the pregnancy risks associated with the use of MPA, pregnancies remain too common in patients being treated with MPAs, leading to preventable adverse pregnancy outcomes.</p> <p><a href="https://www.rockpointe.com/courses/integrating-the-fda-mycophenolate-safety-standards-to-prevent-adverse-pregnancy-outcomes/">Integrating the FDA Mycophenolate Safety Standards to Prevent Adverse Pregnancy Outcomes </a>will provide HCPs who prescribe MPAs with information on MPA-associated pregnancy risks, the need for counseling female patients of reproductive potential on birth control and planning, and the need for reporting pregnancies to the Mycophenolate Pregnancy Registry. It will also provide information to female patients of reproductive potential who are prescribed MPA about the pregnancy risks and the importance of appropriate planning and birth control.</p> <p>A live webinar is scheduled for:</p> <p><strong>Monday, November 8, 2021<br /> 8:30 – 9:30 PM ET</strong> (7:30 – 8:30 PM CT / 6:30 – 7:30 PM MT / 5:30 – 6:30 PM PT)</p> <p>There is no fee for this educational activity. To receive credit, participants must register, participate in the one-hour-long activity, complete the online post-test with a score of at least 70%, and complete the online evaluation. Participants are allowed to take the post-test multiple times.</p> <p><a href="https://cme.rockpointe.com/1097-mycophenolate-safety-standards-to-prevent-adverse-pregnancy-outcomes-coverys"><strong>For more information and to register for this activity, click here.</strong></a></p> <p>An on-demand webcourse will be available on <a href="http://www.rockpointe.com">www.rockpointe.com</a> in the near future.</p> <p><strong><em>Physician Accreditation and Credit Designation Statements</em></strong></p> <p>This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Boston University School of Medicine and Rockpointe. Boston University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.</p> <p>The Boston University School of Medicine designates this live activity material/booklet for a maximum of 1.0 <em>AMA PRA Category 1 Credit<img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /></em>. Physicians should claim only the credit commensurate with the extent of their participation in the activity.</p> <p>For questions regarding CME credit or the evaluation, please email <a href="mailto:cme@bu.edu">cme@bu.edu</a>.</p> <p><strong><em>Nursing Accreditation Statement</em></strong></p> <p>This educational activity has been provided by Boston University School of Medicine Continuing Nursing Education and jointly provided by the Potomac Center for Medical Education and Rockpointe.</p> <p>Boston University School of Medicine Continuing Nursing Education is accredited with distinction as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.</p> <p>Contact Hours: 1.0 of which 1.0 are eligible for pharmacology credit.</p> <p>For questions regarding CE credit or the evaluation, please email <a href="mailto:cme@bu.edu">cme@bu.edu</a>.</p> <p><strong><em>Pharmacist Accreditation Statement</em></strong></p> <p>The Potomac Center for Medical Education is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.</p> <p>The Potomac Center for Medical Education designates this educational activity for a maximum of 1.0 hours (0.10 CEUs) of continuing education credit. UAN Number: 0418-9999-21-004-L05-P.</p> <p>This is an application activity.</p> <p>For questions regarding CPE credit or the evaluation please contact <a href="mailto:cme@potomacme.org">cme@potomacme.org</a></p> <p>This activity is jointly provided by the Boston School of Medicine, Potomac Center for Medical Education, and Rockpointe.</p> <p>This activity is supported by an independent medical education grant from the Mycophenolate REMS Group. This activity is intended to be fully compliant with the Mycophenolate REMS education requirements issued by the U.S. Food and Drug Administration (FDA).</p> <p>Through effective continuing medical education, Rockpointe strives to improve and advance the quality of patient care. Its educational programs have been at the forefront of new issues in healthcare, including implementing MIPS, combating the national opioid crisis and the COVID-19 pandemic, recognizing issues with vaping, and utilizing technical advances in care. As part of its commitment to quality, Rockpointe works to inform the continuing education community of significant quality-improvement issues through news and analysis on <a href="https://www.policymed.com/">Policy & Medicine</a>, which offers a daily look at legal, regulatory, and compliance issues affecting the pharmaceutical and device industry. Rockpointe also publishes <a href="https://complianceupdate.policymed.com/">Policy & Medicine Compliance Update</a>, a monthly publication that provides a concise update on compliance issues facing the life science industry and goes in-depth into important cases, laws, and regulations in straightforward articles. At Rockpointe, education equals quality.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2021/11/cme-cne-cpe-medical-education-program-helps-physicians-integrate-the-fda-mycophenolate-safety-standards-to-prevent-potential-birth-defects.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>FDA REMS Pain Management and Opioid Therapy: Persistent Knowledge Gaps Among Primary Care Providers Rockpointe Program Shows Need for More Healthcare Provider Education</title> <link>https://www.policymed.com/2021/10/fda-rems-pain-management-and-opioid-therapy-persistent-knowledge-gaps-among-primary-care-providers-rockpointe-program-shows-need-for-more-healthcare-provider-education.html</link> <comments>https://www.policymed.com/2021/10/fda-rems-pain-management-and-opioid-therapy-persistent-knowledge-gaps-among-primary-care-providers-rockpointe-program-shows-need-for-more-healthcare-provider-education.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Wed, 13 Oct 2021 08:33:09 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[Opioids]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=14739</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="697" height="378" src="https://www.policymed.com/wp-content/uploads/2021/10/Pain-Paper.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2021/10/Pain-Paper.jpg 697w, https://www.policymed.com/wp-content/uploads/2021/10/Pain-Paper-300x163.jpg 300w" sizes="auto, (max-width: 697px) 100vw, 697px" /></div>The opioid epidemic that has gripped the US for over 20 years has worsened during the ongoing COVID-19 pandemic with the highest number of drug overdose deaths occurring in 2020. This sobering fact emphasizes the need for healthcare providers (HCPs) to be able to provide evidence-based care and be able to recognize their patients who […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="697" height="378" src="https://www.policymed.com/wp-content/uploads/2021/10/Pain-Paper.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2021/10/Pain-Paper.jpg 697w, https://www.policymed.com/wp-content/uploads/2021/10/Pain-Paper-300x163.jpg 300w" sizes="auto, (max-width: 697px) 100vw, 697px" /></div><p>The opioid epidemic that has gripped the US for over 20 years has worsened during the ongoing COVID-19 pandemic with the highest number of drug overdose deaths occurring in 2020. This sobering fact emphasizes the need for healthcare providers (HCPs) to be able to provide evidence-based care and be able to recognize their patients who are at risk for opioid addiction.</p> <p>To help address this educational need, the US FDA provided a blueprint for continuing education for HCPs in the use of opioid analgesics in pain management in 2016 and an update in 2018. The blueprint defines specific aspects of pain management and opioid analgesic use to be addressed in continuing education (CE), e.g. definitions of pain and its mechanisms, components of an effective treatment plan of pain, managing patients on opioid analgesics, opioid addiction. Rockpointe has developed and presented multiple continuing education programs for HCPs based on these FDA blueprints. Because of the importance of the topic on October 13<sup>th</sup> and 14<sup>th</sup> the <a href="https://www.policymed.com/2021/09/fda-reconsidering-the-need-for-mandatory-opioid-prescriber-education.html">FDA is hosting a public workshop</a> on Opioid REMS and considering requiring making opioid REMS a mandatory requirement for physicians and what that would take.</p> <p>The outcomes from two of these blueprint-based programs developed and presented by <a href="https://www.rockpointe.com/">Rockpointe</a>, a continuing medical education company in Columbia, MD, served as the basis for an article, “<em><a href="https://www.dovepress.com/pain-management-and-opioid-therapy-persistent-knowledge-gaps-among-pri-peer-reviewed-fulltext-article-JPR">Pain Management and Opioid Therapy: Persistent Knowledge Gaps Among Primary Care Providers</a></em>,” published this week in the Journal of Pain Research. Knowledge gaps identified among the 5,571 HCP learners who participated in the programs correlated directly to specific aspects identified by the FDA blueprint including only 12% recognizing examples of nociceptive pain; less than 50% were knowledgeable of proper extended-release opioid conversion and less than 25% selected an appropriate choice when initiating chronic opioid therapy; only 33% identified useful screening tools for opioid use disorder screening. These findings provide insights into the clinical aspects of opioid therapies with which primary care providers continue to struggle and direction for continued efforts to educate HCPs in evidence-based care to patients who are struggling with opioid addicted or are at-risk for addiction.</p> <p>In assessing the outcomes of these programs, Rockpointe found consistent and statistically significant improvements in the knowledge gaps identified above among the participants following completion of the CE programs. Moreover, some of the same improvements, e.g. proper extended-release opioid conversion, were noted within the 90-day follow-up data from a subset of participants, suggesting0404 incorporation of the learning into daily practice. These data demonstrate the ability of educational to address knowledge gaps and improve practices among HCPs in the evidence-based use of opioids to treat patients with acute and chronic pain.</p> <p>To download<a href="https://www.dovepress.com/pain-management-and-opioid-therapy-persistent-knowledge-gaps-among-pri-peer-reviewed-fulltext-article-JPR"> the full paper click here</a></p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2021/10/fda-rems-pain-management-and-opioid-therapy-persistent-knowledge-gaps-among-primary-care-providers-rockpointe-program-shows-need-for-more-healthcare-provider-education.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>HHS OIG Releases Report on Effectiveness of REMS</title> <link>https://www.policymed.com/2020/10/hhs-oig-releases-report-on-effectiveness-of-rems.html</link> <comments>https://www.policymed.com/2020/10/hhs-oig-releases-report-on-effectiveness-of-rems.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Mon, 05 Oct 2020 08:49:06 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[HHS-OIG]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=13872</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="860" height="520" src="https://www.policymed.com/wp-content/uploads/2020/09/oig-hhs-needs-to-push-secure-health-data-exchange-showcase_image-4-a-9552.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/oig-hhs-needs-to-push-secure-health-data-exchange-showcase_image-4-a-9552.jpg 860w, https://www.policymed.com/wp-content/uploads/2020/09/oig-hhs-needs-to-push-secure-health-data-exchange-showcase_image-4-a-9552-300x181.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/09/oig-hhs-needs-to-push-secure-health-data-exchange-showcase_image-4-a-9552-768x464.jpg 768w" sizes="auto, (max-width: 860px) 100vw, 860px" /></div>In late September 2020, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) released a study on the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategies (REMS) addressing the opioid crisis. While FDA specifies the requirements and approves the REMS, the drug manufacturers are responsible for development […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="860" height="520" src="https://www.policymed.com/wp-content/uploads/2020/09/oig-hhs-needs-to-push-secure-health-data-exchange-showcase_image-4-a-9552.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/oig-hhs-needs-to-push-secure-health-data-exchange-showcase_image-4-a-9552.jpg 860w, https://www.policymed.com/wp-content/uploads/2020/09/oig-hhs-needs-to-push-secure-health-data-exchange-showcase_image-4-a-9552-300x181.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/09/oig-hhs-needs-to-push-secure-health-data-exchange-showcase_image-4-a-9552-768x464.jpg 768w" sizes="auto, (max-width: 860px) 100vw, 860px" /></div><p>In late September 2020, the United States Department of Health and Human Services Office of Inspector General (HHS OIG) <a href="https://oig.hhs.gov/oei/reports/OEI-01-17-00510.pdf">released a study</a> on the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategies (REMS) addressing the opioid crisis. While FDA specifies the requirements and approves the REMS, the drug manufacturers are responsible for development and implementation of the program. While REMS have the potential to address the opioid crisis, a prior OIG report from 2013 raised concerns about the FDA’s oversight of the programs and their overall effectiveness. Therefore, this new review looks at the extent to which FDA has held drug manufacturers accountable for mitigating the risk of opioid misuse and abuse through REMS.</p> <p>In conducting the review, HHS OIG analyzed documents related to the REMS for transmucosal immediate-release fentanyl (TIRF) drugs and extended-release/long-acting (ER/LA) opioids from 2011 through 2017. The reviewed documents included all drug manufacturer-submitted assessments, FDA decision memoranda, assessment reviews, inspection reports, and other miscellaneous analyses and correspondence. HHS OIG also interviewed FDA staff about REMS oversight.</p> <p><strong>Findings</strong></p> <p>After conducting the review, <a href="https://oig.hhs.gov/oei/reports/OEI-01-17-00510.asp">HHS OIG found that</a> the FDA “struggled to measure the effectiveness” of the REMS for TIRF drugs and for ER/LA opioids in mitigating opioid misuse.</p> <p><em>TIRF Drugs</em></p> <p>TIRF drugs are short-acting and highly potent opioid analgesics that are approved for breakthrough pain in cancer patients who are opioid-tolerant. TIRF drugs are 50 to 100 times more powerful than morphine. The FDA initially approved the TIRF REMS in 2011 and TIRF manufacturers spent the first two years getting the REMS established. However, after those two initial years, FDA found data that suggested that manufacturers were not meeting their goals and that some of the data for the goals were inadequate. From 2014 to 2017, FDA frequently and consistently responded to its concerns about the data by requesting better data from the manufacturers, or in some cases, even conducting its own analyses.</p> <p>In 2019, FDA announced a modification to the TIRF REMS that put a greater emphasis on making sure that patients who are prescribed TIRF drugs are opioid-tolerant. However, the modification also resulted in a change of phrase – TIRF drugs were not longer recommended to be prescribed and dispensed “only to appropriate patients” (such as those with breakthrough cancer pain), which may wind up giving the wrong idea to doctors who wish to prescribe with TIRF drugs off-label to treat patients with varying pain symptoms.</p> <p>The below exhibit, found in the report, indicates at which stage the overarching goal and certain subgoals were met, partially met, not met, or if the FDA was unable to determine if the goal was met.</p> <p><a href="https://www.policymed.com/wp-content/uploads/2020/09/Capture-3.png"><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-13874" src="https://www.policymed.com/wp-content/uploads/2020/09/Capture-3.png" alt="" width="581" height="703" srcset="https://www.policymed.com/wp-content/uploads/2020/09/Capture-3.png 581w, https://www.policymed.com/wp-content/uploads/2020/09/Capture-3-248x300.png 248w, https://www.policymed.com/wp-content/uploads/2020/09/Capture-3-180x217.png 180w, https://www.policymed.com/wp-content/uploads/2020/09/Capture-3-267x322.png 267w, https://www.policymed.com/wp-content/uploads/2020/09/Capture-3-368x445.png 368w" sizes="auto, (max-width: 581px) 100vw, 581px" /></a></p> <p><em>ER/LA Opioids</em></p> <p>Similar to the problems with the TIRF REMS, in assessments from 2014 through 2017, FDA could not determine whether the ER/LA opioids REMS was reaching its overarching goals due to bad data. What the FDA did determine, though, was that manufacturers repeatedly missed the REMS’ targets for training prescribers. Also similar to the TIRF REMS, FDA often requested manufacturers submit additional data from different sources, but FDA did not often make such a request in enough time for the manufacturers to respond before their next assessments were due.</p> <p>In 2018, FDA modified the REMS goals for ER/LA opioids and moved away from an attempt to measure outcomes to measuring voluntary prescriber training that was intended to teach prescribers about risks.</p> <p>As can be seen below, the FDA has not yet been able to determine whether manufacturers met the overarching goal of the ER/LA opioid REMS.</p> <p><a href="https://www.policymed.com/wp-content/uploads/2020/09/Capture2.png"><img loading="lazy" decoding="async" class="aligncenter size-full wp-image-13873" src="https://www.policymed.com/wp-content/uploads/2020/09/Capture2.png" alt="" width="546" height="261" srcset="https://www.policymed.com/wp-content/uploads/2020/09/Capture2.png 546w, https://www.policymed.com/wp-content/uploads/2020/09/Capture2-300x143.png 300w" sizes="auto, (max-width: 546px) 100vw, 546px" /></a></p> <p><strong>HHS OIG Recommendations</strong></p> <p>At the <a href="https://oig.hhs.gov/oei/reports/OEI-01-17-00510.pdf">conclusion of the report</a>, HHS OIG recommends the following:</p> <ol> <li>That FDA use a new TIRF REMS patient registry to monitor for known areas of risk, such as inappropriate conversions (i.e., switching a patient between different TIRF drugs inappropriately) and off-label prescribing.</li> <li>That FDA strengthen the REMS for opioid analgesics by requiring training for prescribers.</li> <li>That FDA enhance its REMS assessment review process by completing reviews in a timely manner and seeking information on inappropriate prescribing trends from its own Office of Prescription Drug Promotion (OPDP).</li> <li>That FDA seek additional authority to ensure manufacturers are held accountable, if and when appropriate.</li> </ol> <p>The FDA agrees with the first and third recommendations but disagrees with the second. With respect to the fourth and final recommendation, FDA is taking it under advisement and giving it consideration.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2020/10/hhs-oig-releases-report-on-effectiveness-of-rems.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>CDER Issues New MAPP For REMS Assessment Reviews</title> <link>https://www.policymed.com/2020/03/cder-issues-new-mapp-for-rems-assessment-reviews.html</link> <comments>https://www.policymed.com/2020/03/cder-issues-new-mapp-for-rems-assessment-reviews.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Thu, 12 Mar 2020 09:02:00 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=13286</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="500" height="326" src="https://www.policymed.com/wp-content/uploads/2020/03/reviewing-paperwork.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/03/reviewing-paperwork.jpg 500w, https://www.policymed.com/wp-content/uploads/2020/03/reviewing-paperwork-300x196.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/03/reviewing-paperwork-210x136.jpg 210w" sizes="auto, (max-width: 500px) 100vw, 500px" /></div>The US Food and Drug Administration (“FDA”) recently issued a Manual of Policies and Procedures (“MAPP”) describing how the Center for Drug Evaluation and Research (“CDER”) evaluates Risk Evaluation and Mitigation Strategy (“REMS”) submissions, as well as policies and responsibilities pertaining to that review. REMS Assessment Reviews are conducted by the Office of Surveillance and […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="500" height="326" src="https://www.policymed.com/wp-content/uploads/2020/03/reviewing-paperwork.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/03/reviewing-paperwork.jpg 500w, https://www.policymed.com/wp-content/uploads/2020/03/reviewing-paperwork-300x196.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/03/reviewing-paperwork-210x136.jpg 210w" sizes="auto, (max-width: 500px) 100vw, 500px" /></div><p>The US Food and Drug Administration (“FDA”) recently <a href="https://www.fda.gov/media/133675/download">issued</a> a Manual of Policies and Procedures (“MAPP”) describing how the Center for Drug Evaluation and Research (“CDER”) evaluates Risk Evaluation and Mitigation Strategy (“REMS”) submissions, as well as policies and responsibilities pertaining to that review.</p> <p>REMS Assessment Reviews are conducted by the Office of Surveillance and Epidemiology (“OSE”) Division of Risk Management (“DRM”), in conjunction with representatives of the Office of New Drugs (“OND”), Office of Generic Drugs (“OGD”), Office of Compliance and other relevant CDER offices. The review is typically completed no later than 180 days from receipt of the REMS submission.</p> <p>The review will be conducted according to the following steps:</p> <ol> <li>Initiation of REMS Assessment Report Review: OSE notifies DRM when a REMS Assessment Report is submitted to the agency. DRM then “triages” the report to determine if it is complete and whether it is acceptable for review. If so, DRM assigns relevant staff to the review.</li> <li>Review of REMS Assessment Report: To complete the review, DRM drafts review materials and meeting slides which incorporate key findings, preliminary conclusions and recommendations for discussion at the review team meeting. DRM also identifies specific issues that need discussion or input.</li> <li>Discussion of review finding with REMS Assessment Review Team: The team makes determinations as to if the REMS Assessment Report is complete, if the REMS is meeting its risk mitigation goals, if the REMS requires modification, and if the REMS assessment plan requires revisions. The discussion, recommendations and conclusions are then incorporated into the DRM review.</li> <li>Completion of REMS Assessment Review: The final DRM REMS Assessment Review is cleared by the DRM director and then by OND.</li> <li>Communication of Conclusions and Comments to Applicant(s): The OND and OGD drafts language for the REMS Assessment Letter, which is then reviewed by DRM. The OND then clears and signs the REMS Assessment Letter for New Drug Application (“NDA”) and Biologic License Applications (“BLA”) applicants. In the case of Abbreviated New Drug Applications (“ANDA”) applicants, the OGD clears and signs the letter.</li> </ol> <p>The MAPP also discusses background information on when REMS are required, and what REMS may include for NDAs and BLAs, as well as timetables for submission. Finally, the MAPP describes in detail the various FDA offices that review and approve the REMS submissions, as well as their respective functions. The MAPP became effective on December 18, 2019.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2020/03/cder-issues-new-mapp-for-rems-assessment-reviews.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>GAO Report on Access to REMS Drugs Shows Mixed Views on Path Forward</title> <link>https://www.policymed.com/2020/01/gao-report-on-access-to-rems-drugs-shows-mixed-views-on-path-forward.html</link> <comments>https://www.policymed.com/2020/01/gao-report-on-access-to-rems-drugs-shows-mixed-views-on-path-forward.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Fri, 03 Jan 2020 10:02:52 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=13051</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="350" height="312" src="https://www.policymed.com/wp-content/uploads/2020/01/Mixxed-Feelings.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/01/Mixxed-Feelings.jpg 350w, https://www.policymed.com/wp-content/uploads/2020/01/Mixxed-Feelings-300x267.jpg 300w" sizes="auto, (max-width: 350px) 100vw, 350px" /></div>The GAO recently published a report, entitled Generic Drug Development – Stakeholders’ Views of Risk Evaluation and Mitigation Strategies Differ, that details a study of industry views on generic drug company access to approved reference drugs that are subject to risk evaluation and mitigation strategies (“REMS”). According to the Food and Drug Administration (“FDA”) and […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="350" height="312" src="https://www.policymed.com/wp-content/uploads/2020/01/Mixxed-Feelings.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/01/Mixxed-Feelings.jpg 350w, https://www.policymed.com/wp-content/uploads/2020/01/Mixxed-Feelings-300x267.jpg 300w" sizes="auto, (max-width: 350px) 100vw, 350px" /></div><p>The GAO recently published a <a href="https://www.gao.gov/products/GAO-20-94?source=ra">report</a>, entitled <em>Generic Drug Development – Stakeholders’ Views of Risk Evaluation and Mitigation Strategies Differ</em>, that details a study of industry views on generic drug company access to approved reference drugs that are subject to risk evaluation and mitigation strategies (“REMS”). According to the Food and Drug Administration (“FDA”) and Federal Trade Commission (“FTC”), drugs with and without REMS have been subject to practices that can delay or prevent generic drug development and market entry. For the study, GAO interviewed FDA and FTC regulatory professionals from brand manufacturer and generic drug companies, and reviewed public documents, to provide recommendations about how to handle this issue.</p> <p>The report notes the FDA and FTC are limited in what actions they can take when drugs subject to REMS are involved, as compared to non-REMS drugs. However, the report provided the following observations and recommendations to address practices that limit access to samples of reference standard drugs:</p> <p>FDA issued a 2014 draft guidance on how generic companies could obtain a letter from the FDA stating that it would not consider providing reference standard drug samples a REMS violation. However, generic companies said that these letters are not useful because they do not require reference drug manufacturers to share samples. On the other hand, representatives from the reference drug manufacturers indicated that those letters address their safety concerns about providing samples to generics manufacturers.</p> <p>FDA published a list of drug companies in February 2019 identifying reference drug manufacturers that were the subject of access inquiries made to the FDA by generic companies. Only one generic company said that the FDA list was helpful, while one reference drug company said it didn’t know why it was on the list.</p> <p>FTC has reviewed inquiries it received from FDA and generic cases, but has not yet brought a case against a reference drug manufacturer for violating federal antitrust law for refusing to provide samples to generics companies. The FTC has, however, filed amicus briefs in two cases involving drugs with REMS.</p> <p>FDA issued waivers and related guidance to address practices that delays negotiations between reference drug manufacturers and generic manufacturers that are intended to create required shared systems. These initiatives allow generic companies to develop a separate, but comparable shared system. Only one generic company said the guidance was helpful, while one reference drug manufacturer said such waivers put additional compliance burdens on healthcare providers.</p> <p>This GAO report is the latest effort related to the issue of generic company access to reference approved drugs. In May 2019, the House passed a <a href="https://www.congress.gov/bill/116th-congress/house-bill/987">bill</a>, entitled the <em>Strengthening Health Care and Lowering Prescription Drug Costs Act, </em>which requires owners of patented drugs to provide generic companies with samples to develop the requisite data for marketing approval applications of competing generics. Given the amount of recent attention, the issue of generic access to approved reference drugs bears watching.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2020/01/gao-report-on-access-to-rems-drugs-shows-mixed-views-on-path-forward.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>FDA Finalizes Revised Guidance on REMS Revisions and Modifications</title> <link>https://www.policymed.com/2019/09/12615.html</link> <comments>https://www.policymed.com/2019/09/12615.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Wed, 11 Sep 2019 09:03:44 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=12615</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="577" height="338" src="https://www.policymed.com/wp-content/uploads/2019/08/REMS.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2019/08/REMS.jpg 577w, https://www.policymed.com/wp-content/uploads/2019/08/REMS-300x176.jpg 300w, https://www.policymed.com/wp-content/uploads/2019/08/REMS-357x210.jpg 357w" sizes="auto, (max-width: 577px) 100vw, 577px" /></div>The US Food and Drug Administration (“FDA”) finalized a revised guidance on making modifications to risk evaluation and mitigation strategies (“REMS”). The document, entitled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” defines the types of changes to approved REMS, how applicants should submit changes to approved REMS and how the FDA […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="577" height="338" src="https://www.policymed.com/wp-content/uploads/2019/08/REMS.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2019/08/REMS.jpg 577w, https://www.policymed.com/wp-content/uploads/2019/08/REMS-300x176.jpg 300w, https://www.policymed.com/wp-content/uploads/2019/08/REMS-357x210.jpg 357w" sizes="auto, (max-width: 577px) 100vw, 577px" /></div><p>The US Food and Drug Administration (“FDA”) finalized a revised guidance on making modifications to risk evaluation and mitigation strategies (“REMS”). The document, entitled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” defines the types of changes to approved REMS, how applicants should submit changes to approved REMS and how the FDA will process these submissions.</p> <p>The guidance divides proposed changes into subcategories based on a consideration of their degree of effect on the information provided in the REMS related to the serious risks of the drug, the safe use of the drug, and/or the actions that the applicant, patients, providers and other stakeholders must take to comply with the REMS. The subcategories are as follow.</p> <p><strong>Revisions:</strong> REMS revisions are editorial changes that do not affect the information contained in the REMS document and/or materials concerning the serious risk of safe use of the drug, and the actions the enumerated parties must take to comply with the REMS. REMS revisions would include, for example, updates to application holder’s name or contact information, and correction of grammatical errors.</p> <p><strong>Minor Modifications:</strong> Minor REMS modifications are changes that have a limited effect on the information contained in the REMS document and/or materials concerning the serious risk of safe use of the drug, and the actions the enumerated parties must take to comply with the REMS. Minor REMS modifications would include, for example, adding approved new strength or dosage information, and adding an authorized generic.</p> <p><strong>Major Modifications:</strong> Major REMS modifications are changes that have a substantial effect on the information contained in the REMS document and/or materials concerning the serious risk of safe use of the drug, and the actions the enumerated parties must take to comply with the REMS. Major REMS modifications would include, for example, adding or removing a REMS goal, or adding a new indication that may alter the serious risks of the drug for the new patient population.</p> <p>The guidance indicates that a “REMS Revision,” which is similar to drug correspondence, should be submitted at the revision is implemented and should be documented in the subsequent annual report. REMS Revisions do not require FDA action, and, consequently can be implemented following FDA receipt of the document. Proposed Minor REMS modifications should be submitted as “changes being effected in 30 days” (“CBE-30”) supplements, and they will be acted on within 60 days of receipt. Applicants can implement those modifications in 30 days, but they are not considered final until approved by the FDA.</p> <p>Proposed Major REMS modifications should be submitted as a prior approval supplement (“PAS”), and they will be acted on within 180 days. These proposed changes may not be implemented until they are approved.</p> <p>This guidance updates a prior guidance with the same title, issued on April 7, 2015.</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2019/09/12615.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary — Final Guidance</title> <link>https://www.policymed.com/2019/04/rems-fdas-application-of-statutory-factors-in-determining-when-a-rems-is-necessary-final-guidance.html</link> <comments>https://www.policymed.com/2019/04/rems-fdas-application-of-statutory-factors-in-determining-when-a-rems-is-necessary-final-guidance.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Mon, 22 Apr 2019 09:05:34 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[Drug Safety]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=12154</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="600" height="338" src="https://www.policymed.com/wp-content/uploads/2019/04/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/2019/04/FDA-Headquarters.jpg 600w, https://www.policymed.com/wp-content/uploads/2019/04/FDA-Headquarters-300x169.jpg 300w" sizes="auto, (max-width: 600px) 100vw, 600px" /></div>Recently the FDA issued final guidance on FDA’s application of the statutory factors in determining when a risk evaluation and mitigation strategy (REMS) is necessary. This guidance clarifies how FDA determines whether a REMS is necessary to ensure that a drug is used in a way where its benefits outweigh its risks. REMS A REMS […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="600" height="338" src="https://www.policymed.com/wp-content/uploads/2019/04/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/2019/04/FDA-Headquarters.jpg 600w, https://www.policymed.com/wp-content/uploads/2019/04/FDA-Headquarters-300x169.jpg 300w" sizes="auto, (max-width: 600px) 100vw, 600px" /></div><p>Recently the FDA <a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM521504.pdf">issued final guidance</a> on FDA’s application of the statutory factors in determining when a risk evaluation and mitigation strategy (REMS) is necessary. This guidance clarifies how FDA determines whether a REMS is necessary to ensure that a drug is used in a way where its benefits outweigh its risks.</p> <p><strong>REMS</strong></p> <p>A REMS is one tool that FDA can develop and utilize to preserve a drug’s benefits while reducing its risks to an acceptable level. For example, a REMS may require health care providers who prescribe the drug to undergo specialized training, or mandate that the drug only be dispensed to patients in certain health care settings, such as hospitals, where the patient can be closely monitored. If FDA determines that a drug’s risks would exceed its benefits even if a REMS is required, FDA will not approve the drug.</p> <p><strong>Six Factors</strong></p> <p>Section 505-1(a)(1) of the FDCA requires FDA to consider six factors when determining whether a REMS should be required: (1) The seriousness and nature of known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug. (2) The expected benefit of the drug with respect to the disease or condition. (3) The seriousness of the disease or condition to be treated. (4) Whether the drug is a new molecular entity. (5) The expected or actual duration of treatment with the drug. (6) The estimated size of the population likely to use the drug.</p> <p>No single factor is determinative, and the relative weight of each factor is a case-specific inquiry. In addition to the six factors listed above, FDA will also consider the potential burdens that a REMS may impose on patients and health care providers, and whether a REMS can be designed that adequately minimizes those burdens</p> <p><strong>Comments</strong></p> <p>As noted by <a href="https://www.raps.org/news-and-articles/news-articles/2019/4/when-a-rems-is-necessary-fda-finalizes-guidance">Regulatory Focus</a>, FDA received <a href="https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&dct=PS&D=FDA-2016-D-2730">six comments</a> on the draft guidance. Commenters sought further information from the FDA on how it weighs the six factors when determining a REMS is necessary. Other comments included minor clarifying remarks on how the factors are applied and comments asking FDA to expand on which REMS elements should be used when it is determined a REMS is necessary.</p> <p> </p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2019/04/rems-fdas-application-of-statutory-factors-in-determining-when-a-rems-is-necessary-final-guidance.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> <item> <title>JAMA Article Outlines REMS Failure, Suggests Reforms</title> <link>https://www.policymed.com/2019/04/jama-article-outlines-rems-failure-suggests-reforms.html</link> <comments>https://www.policymed.com/2019/04/jama-article-outlines-rems-failure-suggests-reforms.html#respond</comments> <dc:creator><![CDATA[Thomas Sullivan]]></dc:creator> <pubDate>Mon, 08 Apr 2019 09:13:42 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[REMS]]></category> <category><![CDATA[NEW]]></category> <guid isPermaLink="false">https://www.policymed.com/?p=12118</guid> <description><![CDATA[<div style="margin-bottom:20px;"><img width="960" height="638" src="https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes.jpg 960w, https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes-300x199.jpg 300w, https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes-768x510.jpg 768w, https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes-450x300.jpg 450w" sizes="auto, (max-width: 960px) 100vw, 960px" /></div>In a recent JAMA article, “Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products,” researchers details how an FDA class-wide Risk Evaluation and Mitigation Strategy (REMS) did not prevent the inappropriate prescribing of transmucosal immediate-release fentanyls (TIRFs), which were approved solely for breakthrough cancer pain in opioid-tolerant patients. Study As […]]]></description> <content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="960" height="638" src="https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes.jpg 960w, https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes-300x199.jpg 300w, https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes-768x510.jpg 768w, https://www.policymed.com/wp-content/uploads/2018/11/CMS-Part-D-and-MA-changes-450x300.jpg 450w" sizes="auto, (max-width: 960px) 100vw, 960px" /></div><p>In a recent JAMA article, “<a href="https://jamanetwork.com/journals/jama/article-abstract/2725233">Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products</a>,” researchers details how an FDA class-wide Risk Evaluation and Mitigation Strategy (REMS) did not prevent the inappropriate prescribing of transmucosal immediate-release fentanyls (TIRFs), which were approved solely for breakthrough cancer pain in opioid-tolerant patients.</p> <p><strong>Study</strong></p> <p>As described in the study’s “Key Points,” the major question in consideration asks if the FDA’s TIRF REMS met its goal of preventing inappropriate use of TIRF products, such as prescribing to patients without opioid tolerance. Since 2007, the FDA has used Risk Evaluation and Mitigation Strategies to support the safe use of prescription medications. Because of their potency and potential for overdose if used inappropriately, on December 28, 2011, the FDA approved a highly restrictive REMS for all transmucosal immediate-release fentanyl products, a class of short-acting fentanyls delivered through sublingual and buccal tablets, lozenges, and sprays approved solely for the management of breakthrough cancer pain in opioid-tolerant patients.</p> <p>The researched reviewed 4877 pages of FDA documents obtained through a Freedom of Information Act request, including 6 annual REMS assessment reports (2012-2017), FDA evaluations of these reports, and FDA-sponsor correspondence about safety issues. The primary outcomes were results of knowledge, attitudes, and behavior surveys of prescribers, pharmacists, and patients; survey- and claims-based prescribing assessments; iterative communication between the FDA and TIRF manufacturers from March 2012, when the REMS was initiated, to December 2017, the date of the last FDA assessment we received; subsequent modifications to the REMS program; and detection and disenrollment of physicians prescribing TIRFs to opioid-nontolerant patients.</p> <p>“Analyses of health plan data indicated that thousands of patients receiving TIRFs were opioid-nontolerant,” the study found. Although surveys of pharmacists, prescribers and patients showed high levels of knowledge about proper TIRF prescribing, some survey items and claims-based analyses “indicated substantial rates of inappropriate TIRF use. Despite these findings, the FDA did not require substantive changes to the program,” the researchers wrote. In addition, the REMS program had a noncompliance plan, but there were no reports of prescribers being disenrolled for inappropriate prescribing.</p> <p><strong>Editorial</strong></p> <p>Accompanying the study is an <a href="https://jamanetwork.com/journals/jama/article-abstract/2725216">editorial</a> from Ameet Sarpatwari, JD, PhD, a professor in the Program On Regulation, Therapeutics, And Law (PORTAL) at Harvard Medical School and Gregory Curfman, the deputy editor of JAMA, who explain how the study raises serious questions.</p> <p>“These findings highlight not just deficiencies with the structure and administration of the TIRF REMS, but problems with the REMS system more generally. Although the FDA has taken steps to improve this system in recent years, including efforts to standardize, integrate, and evaluate REMS programs, additional action is needed,” the editorial says.</p> <p>The authors outline three necessary reforms:</p> <p>“First, REMS should be designed by the FDA with manufacturer input—not vice versa—and be administered by a neutral third party paid by the FDA with newly instituted REMS user fees.”</p> <p>“Second, REMS assessments submitted to the FDA should be publicly available. It is disturbing that it took 5 years for Rollman et al to secure the FDA documents on which they based their review.”</p> <p>“Third, for REMS to ensure safe use of clinically useful prescription drugs with potentially significant adverse effects, the FDA will need to be more assertive in requesting specific analyses pertaining to the performance of REMS programs and in restructuring ETASU in response to concerns the analyses raise.”</p> ]]></content:encoded> <wfw:commentRss>https://www.policymed.com/2019/04/jama-article-outlines-rems-failure-suggests-reforms.html/feed</wfw:commentRss> <slash:comments>0</slash:comments> </item> </channel> </rss>