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.

Bipartisan Policy Center Holds Panel Discussion on Drug Pricing

The Bipartisan Policy Center has plans to host three educational forums over the next several months, focused on the national conversation on affordable prescriptions. The purpose of these forums is to inform the conversation, and to help provide an understanding of how private sector decisions and public sector policies impact the prices of drugs and their costs to the healthcare system.

The first of these scheduled forums addressed how drugs are priced and re-priced, who gets what rebate, and how payer actions affect patient access. Dr. Jack Hoadley, a research professor at the McCourt School of Public Policy at Georgetown University, offered the opening remarks, and a panel discussion with Kirsten Axelsen, the Vice President in Worldwide Policy at Pfizer; Mary Dwight, the Senior Vice President for Policy and Patient Assistance Programs at the Cystic Fibrosis Foundation; Tom Moriarty, the Executive Vice President, Chief Health Strategy Officer, and General Counsel of CVSHealth; Dr. Edmund Pezalla, the Vice President and National Medical Director for Pharmaceutical Policy and Strategy at Aetna; and Dr. Wayne Riley, the President of the American College of Physicians.

Opening Remarks

Dr. Hoadley began his opening remarks with a graph of drug spending growth from the 1970s through a projected 2024 amount. He noted that spending growth had remained flat for a period of time, but growth has recently increased fairly quickly and that growth is projected to be high going into the future. He attributed the rise in drug spending, at least in part, to single-source, high-cost drugs, and the likely continuance of rising drug prices can be attributed to specialty drugs in the current pipeline.

Dr. Hoadley believes that drug prices are impacted by the way drugs are paid for. Historically, he said, drugs were not a benefit covered by insurance, and even if they were, the patient could expect to pay upfront for the prescription and hope to be reimbursed by their insurance company. As times changes, and drugs became a covered cost, the price of drugs went up and beneficiary out-of-pocket costs went down.

Dr. Hoadley used his opening remarks to encourage stakeholders to consider the many possible definitions of "price": ranging from list prices, prices as calculated by large institutional payers, or prices after manufacturer discounts. He also encouraged a review of prices from both the supply side, and the demand side, as well as a more transparent process as to how prices are set.

Panel Discussion

Drug Pricing

Ms. Axelson stated that while the list price is easy to understand and identify, a drug's true price should consider several factors, including: the value of the drug according to the health plan, the portion of the drug cost the patient will be responsible for, the availability of patient assistance programs, discounts offered, and the availability of hardship exemptions. She also noted that drug pricing becomes more realistic and accurate over time as clinical information becomes available.


Related to drug pricing is the subject of rebates. Mr. Moriarty suggested that competition is key and that historically, price competition has resulted in better quality and more access. He also noted that tier placement of a medication had an impact on the rebate received and that oftentimes, the majority of the rebate goes to the plan sponsor who is underwriting the benefit.

Prescribing Practice

Price has an impact on prescribing habits of physicians, too, as noted by Dr. Riley. He noted that one way to drive down prescription costs is to prescribe generic medications more often. However, he also mentioned that some generics are beginning to get extraordinarily expensive as well, concerned that high generic drug prices could lead to a lack of patient adherence and ultimately, patient outcomes.


Transparency has been a huge issue and each panelist brought a different perspective to the discussion. For example, Ms. Dwight discussed patient registries, which would allow insight into which treatments are effective for specific individual patients, and which ones tend to be more effective across the board. Ms. Axelsen mentioned that she felt drug pricing is "very transparent" since list prices are available and most companies publish their research and development costs. She believes that when looking at medical services in the healthcare system, drug pricing actually stands out as one of the most transparent. She mentioned that it is oftentimes hard for companies to be even more transparent than they already are since there are regulatory hurdles that are preventing manufacturers from sharing specific information about the medication outside of what can be gathered from clinical trials that support the drug's approval.


As mentioned, there are several more educational forums to come from the Bipartisan Policy Center over the next several months. There will be one on May 10, 2016, on the way existing federal statutes and regulations impact pharmaceutical innovation, market competition, and costs. The final one is scheduled fro June 16, 2016, which will focus on how pharmaceuticals fit into value-based payment and whether or not there are models for financing breakthrough treatments. These topics are all timely and relevant, and we encourage our readers to stay abreast of discussions revolving around the hot topic of drug pricing.


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).

To Read the Full Story, Subscribe, Download a Sample Issue, or Sign In


Preview | Powered by FeedBlitz


May 2016
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30 31