Life Science Compliance Update

April 20, 2017

FDA Public Workshop on Opioid Training


The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with federal efforts to train prescribers on pain management and the safe use of opioids.

The workshop has three major goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. As a part of this discussion, current training efforts by States, hospitals and health care systems, Federal Agencies, professional associations and other groups will be considered in order to strategize how best to facilitate training for these health care providers. Finally, participants will also be asked about issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.

The public meeting, “Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics – Exploring the Path Forward,” is scheduled for May 9th and 10th, 2017, from 8:30 am to 5:00 pm on the 9th and 8:30 am – 4:30 pm on the 10th. The event will be hosted at the Sheraton in Silver Spring, Maryland.

Seating for this event is limited and the FDA may limit the number of participants from each organization. If you are interested in attending, either in person or via webcast, you can register here. Registration closes for the event on May 1, 2017.

During online registration, you may indicate if you wish to provide a statement during the Open Public Comment Period. The FDA will do what it can to accommodate requests to make public comments based on time allocated for public comment. Individuals and organizations with common interests are urged to consolidate or coordinate their comments, and request time for a joint presentation. Following the close of registration date, the FDA will determine the amount of time allotted to each commenter and the approximate time each oral comment is scheduled to begin; commenters should arrive ahead of their scheduled time in case the agenda moves ahead of schedule so as to be sure not to forfeit their speaking time. All requests to make oral comments must be received by the close of registration on May 1, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

If time and space permit, the FDA will allow for onsite registration on the day of the workshop, starting at 7:30 am.

Comments can be submitted either electronically or written by July 10, 2017.  

January 13, 2017

FDA Issues Guidance on REMS


With the passage of the long-awaited 21st Century Cures legislation, we saw Senator Mike Lee (R-UT) vote “no” because the bill did not include language that would allow generic pharmaceutical companies to obtain samples of products under the Risk Evaluation and Mitigation Strategies (REMS) program. Senator Lee an others, including Senator Chuck Grassley (R-IA) and Patrick Leahy (D-VT) had supported an amendment to Cures based on a legislative proposal that would improve the REMS process as a method to control drug prices. This is why it is interesting to review a draft guidance from FDA that tries to further explain the application of REMS regulatory paradigm, which can ultimately delay generic drug competition. A REMS can be a medication guide or package insert or communication plan that is required by FDA to ensure that the benefits of a drug outweighs the risks.

40 percent of FDA approvals are subjected to REMS

In a 2014 report, the Generic Pharmaceutical Association (GPhA) wrote that nearly 40 percent of new FDA approvals are subject to REMS, and brand manufacturers have also begun imposing distribution restrictions on non-REMS products. “Government, consumers, and private payors are already missing out on sizeable health care savings from misuse of these programs. Specifically, REMS and non-REMS strategies to restrict access to brand drug samples represent lost savings on small-molecule drugs of at least $5.4 billion annually,” said the GPhA.

FDA Guidance

The 14-page draft, “FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary,” offers some explanation for how it tries to address the burden of the REMS program.

The FDAAA requires FDA to consider the following six factors in making a decision about whether to require a REMS:

  • The seriousness of any 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;
  • The expected benefit of the drug with respect to the disease or condition;
  • The seriousness of the disease or condition that is to be treated with the drug;
  • Whether the drug is a new molecular entity;
  • The expected or actual duration of treatment with the drug;
  • The estimated size of the population likely to use the drug.

These six factors influence FDA’s decisions with respect to both whether a REMS is required for a particular drug and what type of REMS might be necessary (i.e., what specific elements or tools should be included as part of the REMS). FDA makes decisions about requiring a REMS as part of a benefit-risk determination for a drug after an evaluation that includes integrated consideration of each of the statutory factors. No single factor, by itself, is determinative as to whether a REMS is necessary to ensure that the benefits of a drug outweigh its risks.

The more serious a drug’s known or potential associated risks relative to its benefits, the more likely it is that a REMS will be necessary to ensure a favorable benefit-risk balance, without which the drug could not be approved. In determining whether to require a REMS, FDA considers the source, nature and reliability of available scientific evidence about the adverse events as well as the characteristics of the risks, including the severity, frequency, temporality, preventability, reversibility, background incidence, and likelihood of occurrence of the adverse events.

When assessing a drug’s expected benefits with respect to a specific disease or condition in considering whether a REMS is necessary, FDA may evaluate information about the drug’s effectiveness, whether the drug treats a serious disease or condition, whether it fills an unmet medical need, and whether it can cure the disease or alleviate its symptoms. FDA may also consider the extent to which new dosage forms enhance convenience of administration and/or improve adherence to prescribed regimens, and whether new formulations or delivery mechanisms may extend treatment to patient populations who were formerly unable to use the drug. A drug’s expected benefits, however, are not considered in isolation. In determining whether a REMS is necessary, FDA’s assessment of a drug’s benefit is balanced against consideration of the risks associated with its use.


In the conclusion of its guidance, the agency writes, “FDA understands that REMS, particularly those with ETASU, may impose some measure of burden on patients and/or health care providers. When considering this burden on patient access and the health care delivery system, FDA takes into account existing REMS elements for other drugs with similar risks and whether the REMS under consideration can be designed to be compatible with established medical drug distribution, procurement, and dispensing systems.”

The FDA also looks at patients for whom the drug is indicated currently access health care and whether the REMS may impose additional access difficulties. FDA also takes into account the consequences of potential treatment interruption or delays, particularly where patients have serious or life-threatening conditions and/or have difficulty accessing health care. In such circumstances, FDA claims it takes steps, to the extent possible, to ensure that REMS are designed to minimize delays or interruptions in drug therapy that may have untoward clinical impact.

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.


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