Does FDA Regulate REMS Enough?

Does FDA Regulate REMS Enough?

February 15th, 2013 // 4:44 pm @


For the past few years, the Risk Evaluation and Mitigation Strategies, or REMS, has been a controversial effort. Designed in the wake of several safety scandals, a REMS program is required when risks are sufficiently worrisome, but there is growing criticism the requirements have become poor substitutes for education. Still worse, a new report finds the FDA lacks comprehensive data to determine whether the program really does improve safety.

In the first independent review of the REMS initiative since it began five years ago, the US Department Health and Human Services Office of Inspector General is not receiving needed information from drugmakers about whether their medicines are being used safely by physicians and patients. The implication, of course, is that drugmakers are ignoring requirements and the FDA has failed to follow up.

A REMS program, you may recall, includes materials for patients that warn about side effects, specialized training for physicians and other healthcare providers who prescribe such a drug and limited distribution by certain hospitals or pharmacies. A REMS program has been required for dozens of drugs but many have since been released (you can see the list here).

In its review, the OIG noted that the FDA approved 199 REMS between 2008 and 2011, including 99 that were still required last year. Nearly half of sponsor assessments for 49 REMS reviewed did not include all data requested in FDA assessment plans and 10 were not submitted on time. The FDA determined seven of the 49 REMS met agency goals, but the FDA has not identified reliable methods to assess the effectiveness of REMS, the OIG states.

There was another problem: FDA assessment review times exceeded the stated agency goal of 60 days for all but one sponsor assessment, which reduces the time a sponsor has to make suggested changes before submitting subsequent assessments. In short, the FDA has done such a poor job of oversight, the OIG is questioning the effectiveness of the entire program (here is the report).

To get REMS back on track, the OIG suggests the FDA devise a workable assessment plan and work with drugmakers and healthcare providers to develop better evaluation tools, rather than rely on sponsor surveys. What else? OIG recommends the FDA remove a drug from market if a REMS fails to meet its goals; evaluate a REMS status annually; nag drugmakers more often to fulfill their requirements; clarify agency expectations of drugmakers and seek legislative authority to enforce assessment plans.

How did the FDA react? The agency largely agreed with the OIG, and noted there has been insufficient experience achieving the various goals, since the program is still relatively new. But the agency intends to write draft guidances on how to write REMS goals and determining proper metrics. The FDA also plans to hold workshops to get more input from drugmakers and physicians, among others.

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