According to a recent report from HHS-OIG, pharmaceutical manufacturers are playing games with the FDA when it comes to providing information about how patients and prescribers are using some of the riskiest drugs on the market. Adding insult to injury, there is nothing the FDA can do about it.
The report was done to assess how the FDA is handling so-called “Risk Evaluation and Mitigation Strategies” (REMS), which are supposed to check on whether potentially-dangerous drugs are actually doing what they are supposed to do after the FDA approves them. The REMS can include checking on results, producing brochures to warn patients about side effects, limit which hospitals and pharmacies get especially dangerous drugs and special training for doctors.
However, the entire REMS process seems to operate on an honor-code system, with drugmakers self-assessing and self-reporting. Needless to say, some companies have been slow to report adverse events, especially with revenue numbers climbing in the void of safety concerns.
HHS-OIG noted, “The FDA does not have the authority to take enforcement actions against sponsors [drug companies] that do not include all information requested in FDA assessment plans.” HHS-OIG, in turn, begs Congress to fix this problem during the current legislative session.
If, however, Congress turns a blind eye to the problem, drugmakers undoubtedly, will continue to slow-walk problems to the FDA. Until then, the FDA will need to rely on whistleblowers to report known safety problems that are jeopardizing patients’ lives.
More information for whistleblowers is located at the Nolan Auerbach website.