The Drug Safety and Risk Management Committee (DSaRM) is a panel composed of FDA appointed members who advise the agency on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use.
DSaRM consists of a core of 13 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in risk communication, risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management and drug abuse. The voting membership may include one technically qualified member individual who is recommended by either a consortium of consumer-oriented organizations or other interested persons to represent the interest of the consumer on the committee. In addition, the committee includes a non-voting member who identifies with industry interests.
While DSaRM is structured the same as any other advisory committee, it is vastly different in terms of focus and importance. While most other FDA advisory committees meet to discuss matters regarding new drugs, DSaRM was chartered to review and quantitatively evaluate information with regard to safety, efficacy, and abuse potential of drugs that are already on the market. Given the committee’s role in drug review, DSaRM recommendations and FDA’s resulting regulatory decisions can serve as a proxy for understanding the drug safety regulatory environment.
DSaRM has already exceeded the typical number of meetings it holds each year, meeting five times so far, and from these meetings one can gain a sense of the increasing focus on drug safety in 2013. In January, the committee met to discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone. The committee discussed the impact of rescheduling hydrocodone products from Schedule III to Schedule II of the Controlled Substances Act and subsequently voted in favor of rescheduling these hydrocodone products.
In two other meetings held in March and April, the committee joined the Reproductive Health Drugs Advisory Committee (RHDAC) to evaluate the risks and benefits of a currently marketed product (Miacalcin) and a new product (AVEED, NDA 22219). The meetings for Miacalcin (calciton salmon) injection and Miacalcin nasal spray, (Novartis Pharmaceuticals Corporation), and AVEED (testosterone undecanoate) intramuscular injection (Endo Pharmaceutical Solutions, Inc) resulted in split decisions by the committees; highlighting the complexity of safety issues, communication and the ability to achieve consensus not only for new drugs, but also for drugs that have been on the market for many years.
In June, a joint meeting of DSaRM and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) discussed the results of an independent re-adjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial, for NDA 21071, AVANDIA (rosiglitazone maleate) tablets. The joint committee voted to continue to make AVANDIA available to appropriate patients; with the majority of the members voting to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program previously put in place. Over the course of the meeting committee members continually stated their belief that the underlying flaws of RECORD– especially its open-label, non-inferiority design and a large amount of missing data– ensured that it could never definitively eliminate the cloud of uncertainty over rosiglitazone’s safety.
In the most recent meeting of DSaRM, held in July, the committee voted to switch to electronic prescribing for alosetron hydrochloride (LATRONEX) (Prometheus Labs Inc.), in addition to retaining and refining other aspects of the current risk management system that restricts its availability.
Innovative Science Solutions has provided support for sponsors participating in numerous meetings of the DSaRM, including the recent Miacalcin and Ortho Evra AdComms. With both new and old drugs becoming more and more scrutinized, detailed preparation for DSaRM meetings is critical. ISS’ experience with DSaRM sets us apart from others, as we understand the multifaceted issues that affect the outcome of these meetings, especially issues related to risk communication, which may be challenged by patient advocacy groups and affected patients present at these meetings. It is this experience that allows us to provide high quality insight into preparing for these issues and tackling them head on.
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