Review: FDA Lacks Compete Data to Determine if Current Strategies Improve Drug Safety


Following a study on the way in which the U.S. Food & Drug Administration (FDA) handles drug safety, the Office of the Inspector General, U.S. Department of Health and Human Services said that its findings raise concerns about the drug safety Risk Evaluation and Mitigation Strategies (REMS) program’s overall efficacy. Specifically, the Office concluded that the agency does not have sufficient comprehensive data to make a determination concerning, or improvements to, REMS.

As we’ve explained, the REMS measure is part of a federal initiative to address the ongoing issues and growing epidemic concerning prescription drug abuse, misuse, and overdose. For instance, REMS introduces new safety measures meant to reduce risks and improve the safe use of opioid drugs while also ensuring access to these medications when needed for patients who are in pain. REMS also mandates companies make FDA-approved patient education materials available with the safe use of specific drugs and also perform periodic assessments of the REMS implementation and program success in meeting its goals. The FDA is supposed to review assessments and may require additional elements to achieve the program’s goals.

The FDA has a mandate in place for drug makers to submit structured plans—the so-called REMS—for any drug linked with known or potential risks that might outweigh the drug’s benefits, the Office explained. Should the agency not appropriately monitor REMS’ performance, it is not able to ensure full protection to consumers of any given drug’s known or possible risks. Meanwhile the FDA does not possess authority to mandate that a drug maker or its sponsor provide specific REMS’ efficacy data; the agency may request this data, however.

The Office reviewed approved REMS since its implementation in 2008 and through 2011. To accomplish this, the Office conducted structured interviews with FDA officials about the way in which the agency evaluates REMS components, reviewing 49 sponsors’ REMS assessments, as well as the agency’s reviews of those assessments. This was done to understand the completeness of the sponsors’ assessments, if the agency submitted the assessments within mandated times frames, and if REMS were meeting its goals. The Office also reviewed if the FDA evaluated the Elements To Assure Safe Use (ETASU) of one drug in each year of the REMS program, which is required under federal law.

The office discovered that the FDA approved 199 REMS from 2008 and 2011; 99 of these were still required in 2012. About half of the sponsor assessments for the 49 REMS the Office did review were missing complete information requested in the FDA’s assessment plans; 10 were never submitted to FDA within mandated timeframes. The agency concluded that 7 of 49 REMS the Office reviewed met all of its goals.

The FDA has not identified any reliable methods to assess REMS efficacy, the Office found. The Office also discovered that the agency’s assessment review times exceeded the required 60-day goal in all but one of the sponsor assessments. This, said the Office, reduces sponsors’ time to implement any suggested changes prior to submitting follow-up assessments.

To address its concerns, said the Office, it made seven recommendations regarding FDA’s evaluation and assessment of REMS and its review of sponsors’ REMS assessments. The FDA concurred with six of the seven recommendations.

For the remaining recommendation, the Office said it will seek legislative authority to ensure that FDA assessment plans are enforceable; the FDA did not state whether it did or did not concur with the recommendation, the Office noted. The FDA did agree that the recommendation be considered if another opportunity arises to pursue legislative changes to the statutory provisions describing REMS assessments requirements.

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