Life Science Compliance Update

May 05, 2016

FDA ER-LA REMS Day 2 of the Drug Safety and Risk Management Advisory Committee

Day Two of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) was lively and full of debate and conversation.

The day started out with comments from the FDA, followed by presentations by Joanna G. Katzman, MD, MSPH, of the University of New Mexico Health Sciences Center and Graham McMahon, MD, the President and CEO of the Accreditation Council for Continuing Medical Education (ACCME).

The bulk of the morning was spent on the "Open Public Hearing" portion, where twenty-three participants, from various walks of life, various viewpoints, and with various reasons for involvement, gave their opinion on modification of REMS. Many of the speakers had positive things to say about REMS and CME, including many who believe that CME should be mandated for prescribers who are trying to obtain or renew their Drug Enforcement Administration (DEA) license, since many physicians and other providers may not voluntarily participate.  The speakers also emphasized the need to expand the current REMS to IR opioids and to expand the scope of the program to target education towards the entire healthcare team and not just prescribers as pain management often requires several layers of help.

Several of the speakers, including Phyllis Zimmer, a board certified nurse practitioner, believe that the current ER-LA Opioid REMS is not an undue burden, nor does it limit patient access to physicians and appropriate care.

Some of the recommendations for updating REMS included: increase transparency for patients; develop a blueprint for patient information; increase the available range of activities, so that physicians and other practitioners can help close their personal gap, not a predetermined gap that may or may not benefit them individually; standardize REMS while allowing for increased flexibility; educate entire healthcare teams, not just physicians; include in the education other treatments that may reduce overall need for opioids; make REMS more comprehensive, including IR; provide education for providers on how to manage "at risk" patients; launch a public health campaign so the entire country is involved; and focus on education that emphasizes fewer patients, shorter duration of prescribing patterns, and lower dosages. Several speakers also mentioned the idea that REMS should include some screening for mental disorders, and provide education to providers on how to handle patients who may suffer from such illnesses.

The afternoon was full of questions to the committee and committee discussion. The committee did not hold a formal vote, but several members of the committee recommend that the FDA should update its education materials to incorporate the new CDC guidelines on opioid prescribing and other material on alternative pain treatments. There was a real concern that the learners were engaged and to do more work to show changes in clinical practice.

The committee also agreed with many morning presenters in recommending the continuing education component be mandatory and tied to DEA licensure, not voluntary, in order to be most effective.

Earlier in the day Graham McMahon, CEO of ACCME outlined how mandatory CME often is not effective in changing clinical practice and called for continuing education for physicians who prescribe opioids to be voluntary.

The committee also urged the FDA to update REMS to include shorter acting opioids, which have the potential to be more dangerous than ER/LA opioids. Critics of that idea believe that opioid manufacturers have too much control and influence over strategy but several of those who expressed concern applauded the REMS Program Committee for their work in supporting this effort.

While the FDA is not required to follow the recommendations of its panelists, history reflects that the opinions and recommendations of panelists have a large effect on the eventual rules.

Exploring Strage New Worlds - FDA’s 2016 Program Alignment and Strategic Priorities

This article provides an overview of the FDA's initiative to realign programs from location-centered structures and specializations to commodities specializations, and its impact on the implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA).

The Food and Drug Administration (FDA) is overhauling its program alignment to shift from a regional structure to commodities-based specializations and vertically-integrated programs. It is an effort aimed at responding to innovations in technology, globalization in FDA-regulated industries, and the demands of new legislation, according to Douglas Stearn, Director of the Office of Enforcement and Import Operations in the FDA's Office of Regulatory Affairs (ORA). As a result, 2016 will be a year of transition for the Agency, which expects to have a program structure in place later this year, Stearn explained to attendees at the 2015 Enforcement, Litigation, and Compliance Conference. These changes will have a profound impact on FDA oversight efforts, especially as they pertain to the Food and Drug Administration Safety and Innovation Act (FDASIA).

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May 04, 2016

FDA ER-LA REMS Day One of Meeting of the Drug Safety and Risk Management Advisory Committee

The Food and Drug Administration (FDA) is hosting a two-day long Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The FDA is seeking comments from the committees as to whether this REMS with Elements to Assure State Use (ETASU): actually assures safe use, does not unduly burden patient access to drugs, and somewhat minimizes the overall burden to the healthcare delivery system.

The day started out with introductory remarks from Janet Woodcock, MD, the Director of the Center for Drug Evaluation and Research (CDER) at the FDA where she outlined the goals of the REMS program and the importance of educating prescribers on safe opioid use.

Next, there were presentations focused on the ER/LA REMS background, history, authority, and a general overview, presented by Terry Toigo, MBA, RPh, and Cynthia LaCivita, PharmD, both of the CDER. Dr. LaCivita noted that there is no national registry tracking which providers have completed the REMS training and which ones have not. Having such a registry where prescribing patterns of all completers could be compared with those of physicians who do not complete the training may offer a clearer picture of the program's total impact.

Wilson Compton, MD, MPE, the Deputy Director of the National Institute on Drug Abuse at the National Institutes of Health, presented on state and federal efforts. Heroin and prescription painkiller abuse tends to be more common in particular areas, such as the Southwest, the Northeast, and rural areas. Additionally, there is a bit of overlap between people who are on Medicaid and those who abuse opioids. As such, Medicaid and individual state budgets tends to shoulder the burden of treating those patients when they are sick. However, as more people become eligible for Medicaid through the federal health law, that burden will likely grow. As such, it will be important in the future for states to create individual plans for combating this epidemic, but also fit their plans in with a larger, federal plan, for all providers.

The morning concluded with presentations by representatives of various REMS Programs Companies (RPC), including Pernix Therapeutics, Albany Medical Center, and Purdue Pharma. Paul Coplan, ScD, delivered program statistics through February 29, 2016, stating a total of 839 CE courses were conducted in the three years of the program, involving a total of 438,461 participants. Of those participants, 66,219 of them who completed the courses were ER/LA prescribers, the target group.

The provider knowledge survey, which assessed whether the education was actually getting through to physicians and prescribers, found that 83% of prescribers understood the material well, as did 86% of their patients.

Discussion ensued as to whether the rate of success is translating into improved outcomes. The discussion seemed as though it was positive for CE and REMS, and that some industry leaders recognize that working with CE providers to help educate providers is beneficial to patients and the healthcare system overall.

The meeting continues Wednesday, May 4, 2016, with discussions that are expected to elicit recommendations from the panel members.


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