Pharmaceutical companies have largely ignored recent federal requirements to compile data and warn doctors and patients of possible side effects caused by their drugs, according to a report from the Department of Health and Human Services’ (HHS) Office of Inspector General.
The report is the first independent report into requirements put in place in 2008 allowing the Food and Drug Administration (FDA) to require drug makers to develop risk-management plans for new drugs. These Risk Evaluation and Mitigation Strategies (REMS) require drug companies to produce patient brochures warning about drug side effects, provide specialized training for doctors who prescribe some drugs, and allow limited distribution of drugs by certain hospitals or pharmacies.
Of the 49 REMS plans reviewed by HHS, 21 were clearly in violation of the guidelines, another 21 were missing too much data to determine performance, and only seven were meeting the goals.
The inspectors did not identify specific companies or drugs, but did say that some manufacturers did not submit enough information about whether patients understood risks associated with their drugs. In other cases, drug makers did not include reports of adverse reactions, and others failed to record the number of doctors were had been certified to prescribe their treatments. Some of the drugs probably would not have received FDA approval had the agency not ordered a REMS, one program analyst said.
While the FDA was granted the power to order REMS, it does not have the authority to penalize drug companies who do not conduct them. The report suggests the FDA be granted this power; however, it is unlikely Congress would pass such a small “fix” to existing health care laws without public pressure.