FDA May Change The Way It Regulates Risky Drugs

The U.S. Food and Drug Administration (FDA) just concluded a two-day meeting to look into the implementation of its Risk Evaluation & Mitigation Strategy Safeguards (REMS). According to Reuters, REMS is meant to protect patients from <"http://www.yourlawyer.com/practice_areas/defective_drugs">risky drugs, but with less paperwork and increased stability. Representatives from the pharmaceutical community were in attendance at the meeting.

REMS is a collection of educational and discovery tools designed to safeguard patients from medications with significant side effects, explained Reuters. The drug industry did acknowledge that REMS has benefits, but asked for less regulation, said Reuters, which noted that the agency said it would look at the requests.

“There has to be obviously the most appropriate balance between protecting the safety of patients, which is of the utmost concern, but also doing so in a way that doesn’t cause unnecessary burdens and inefficiencies in the health care system,” Jeffrey Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America, said, quoted Reuters.

According to InvivoBlog, there were nearly 70 presentations providing input into how to enable safe and appropriate drug marketing, including the American Society of Clinical Oncology, a group that has expressed concern over how the FDA handles REMS’ development. ASCO, the American Medical Association, specialty pharmacy executives, Kaiser, the Pharmaceutical Research & Manufacturers of America, the Biotechnology Industry Organization, and Eli Lilly also were on hand and presented, among others, reported Reuters.

REMS have been in place for some time—since 2008—and include, for instance, those patient medication guides that provide consumers with a breakdown of drug risks, said Reuters. With more dangerous medications, even those expected to be rejected or removed from the market, firms are mandated to train prescribers and, sometimes, track patient health, explained Reuters. REMS are currently required for over 120 drugs.

Among other items, presenters urged increased transparency on REMS decisions, requested information earlier during drug development, and asked for the same restrictions on similar medications, wrote Reuters. Eli Lilly and Co. called for limitations on REMS evaluations, urging that these steps occur for the riskiest of medications and not for drugs requiring a medication guide, according to Reuters.

“In place of this one-size fits all approach, we believe that patients and the stakeholders in the health care system could benefit if the FDA were to adopt a more tailored approach to REMS,” said an Eli Lilly spokesperson, quoted Reuters.

No deadlines or schedule are in place for changes; however, some enhancements are expected sooner rather than later, said Reuters. Jane Axelrad, associate director for policy in the FDA’s drug evaluation unit said, “We’ll be looking at our program to see whether some of the suggestions that we’ve heard can be incorporated into REMS that are under development, into new REMS,” quoted Reuters.

FDA reconsidered REMS following external input, including a petition issued by Kaiser last year. And, while industry does not want to see an elimination of REMS, they are generally interested in being involved in the development and change process.

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