Report Indicates Information on Risky Drugs Not Disclosed to FDA

By February 20, 2013 July 9th, 2019 Drug Safety

A recent report by government inspectors indicates that the Food and Drug Administration (FDA) is failing to receive crucial information from drug makers regarding some of the riskiest prescription drugs currently on the market and whether or not these drugs are safely being used by patients and doctors. Recent federal requirements are specifically designed to manage the drug safety of medications that are particularly high-risk, but the findings in the report suggest that these requirements are being largely ignored by pharmaceutical companies.

This report, issued by the Department of Health and Human Services’ Office of Inspector General, is an independent review of the program, which began in 2008. The program gave the FDA the power to require risk-management plans for new drugs from manufacturers. REMS, or Risk Evaluation and Mitigation Strategies include various requirements including brochures for patients that warn about the side effect of the drug, specialized training for prescribing doctors, and a limit on the distribution of drugs by certain pharmacies or hospitals.

Disturbingly, when inspectors reviewed the assessment of the REMS by the FDA, they discovered that the majority had apparently failed to meet patient safety improvement goals. The inspectors reviewed 49 REMS plans and made the following discoveries:

  • Only 7 REMS plans met all their goals
  • 21 REMS plans clearly weren’t meeting goals
  • Conclusions could not be drawn about 21 REMS plans because of missing information.
  • Only 1 of 19 REMS plans for the riskiest drugs met all of its goals.

According to Sarah Langford, a program analyst, “Some drugs would never have received initial FDA approval, or would have to be removed from the market if they did not have a REMS plan.” Langford also asserts in her report that the failure of drug makers to fulfill REMS requirements stems from the lack of enforcement capability of the FDA. Currently, the FDA has no ability to penalize the companies with either fines or other penalties when they fail to cooperate. Individuals taking risky drugs should be concerned about drug safety and conscious of possible litigation should they experience damaging side effects including medical malpractice and product liability settlements.