Report: FDA Lacks Information Necessary to Monitor Risk Evaluation and Mitigation Strategies

Published Online: Friday, March 15, 2013
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In many cases, the FDA is not getting the information it needs to oversee plans submitted by drug manufacturers to ensure that potentially risky drugs are used safely, according to a report released on February 13, 2013, by the Office of Inspector General of the Department of Health and Human Services. The plans, known as Risk Evaluation and Mitigation Strategies (REMS), are required for drugs that have known or potential risks that may outweigh their benefits.

The report involved interviewing FDA officials regarding the agency’s evaluation of REMS and investigating 49 REMS assessments from drug manufacturers and FDA reviews of them to see if the agency had adequate information to determine whether the REMS were meeting their goals. It found that nearly half of the drug manufacturers’ assessments for the 49 REMS reviewed lacked some of the information requested by the FDA, and 10 were submitted late. The FDA found that 7 of the 49 REMS reviewed met all goals.

According to the report, a primary obstacle to FDA oversight of REMS is that the agency can only request, but not require, drug manufacturers to provide particular pieces of information regarding REMS’ effectiveness. The report includes a number of recommendations for improving the FDA’s oversight of REMS, including getting legislative authority to make FDA assessment plans enforceable.

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“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies programs to thwart competition from more affordable generic drugs. The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors. Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales.
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