Federal Watchdog Says Drugmakers Ignore FDA Drug Safety Requirements
The United States Department of Health and Human Services’ (HHS) Office of the Inspector General, after conducting an independent review of a five year-old FDA program has reported that the majority of drug manufacturers have not been meeting their goals of improving patient safety.
In 2008, the Food and Drug Administration (FDA) established a program which required manufacturers to develop risk management plans for new drugs (Risk Evaluation and Mitigation Strategies (REMS). These risk management plans were to include a variety of strategies such as: patient brochures warning about drug side effects, specialized training for prescribing doctors, and/or limited distribution of drugs by certain hospitals. The REMS program was designed largely in response to a series of high profile drug safety problems caused by drugs such as Vioxx, which were pulled from the market after being determined to cause heart attacks and strokes.
According to the DHHS, out of the 49, only seven drug manufacturers met all their goals. The investigators found that 21 of the plans were clearly not meeting their goals. Investigators were unable to evaluate the remaining 21 plans because too much information was missing to perform an evaluation.
The riskiest drugs have special requirements such as mandating special doctor training or limited distribution. Alarmingly, out of the 19 plans for the riskiest drugs, only one plan was meeting its goals. Eight plans were clearly not meeting their goals and the remaining 10 did not have enough information to make a determination.
While the lack of compliance is frightening for American consumers, drug manufacturers appear to have little to worry about. Currently, the FDA has no power to penalize companies that do not submit all the information needed to determine the efficacy of their REMS plans. The Inspector General’s office, however, has recommended that Congress give the FDA the power to impose fines if they do not cooperate.
If you or a loved one has been injured in the pharmaceutical drug, please contact Khorrami, LLP for a confidential consultation.