FDA Faulted for Flawed Drug Tracking

When you visit your doctor for an illness or a disease, and they prescribe a drug that is supposed to ease your symptoms or cure your illness, you more than likely take the prescription to your local pharmacy, and take the pills as directed. Many Americans blithely assume that the FDA is making sure that the prescription drugs we take are both safe and effective; however, the Government Accountability Office (GAO) has conducted an investigation at the request of Representative Rosa DeLauro (D-Conn.) about the FDA’s lack of oversight for drugs that have been approved to go on the market. The report raises serious concerns about how effective the agency has been as the overseer of drug safety in the U.S.

The FDA has two expedited approval programs through which about a quarter of all medicines that are approved to go to market were permitted between October 2006 and December 2014. The GAO report, published January 15, 2016, shows how the FDA has failed to address several gaps in its process for monitoring drug safety issues once a drug has made it to market (post-market monitoring). The fast track approval system is said to compromise patient safety because it allows drug manufacturers to delay the presentation of their safety and efficacy evidence until after a drug is already being sold to and consumed by the public. One the FDA approves a drug it is required to monitor the drug’s safety, and the manufacturer’s efforts to study the effect of the medicine once it is made available to the public.

The GAO report looked at how the FDA was managing those requirements, and what they discovered was not good. Some of the issues that the GAO report uncovered included:

• The FDA’s failure to monitor safety issues in its computer database
• Failure to complete a timely review of the follow-up studies it had requested
• A computer database that did not allow for sorting by disease type, FDA action or patient population

GAO investigators found backlogs in the review of reports from drug makers on post-market studies.

The GOA report said, “FDA’s data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult.”

The watchdog agency recommended that the FDA develop in-depth plans to overhaul its database so that it can be updated more easily.

If the majority of the potential safety issues are not being identified and tracked by the FDA, and they are allowing drugs to be fast-tracked to market, then it falls to the public to discover that a drug has safety or efficacy problems. For its part, the FDA said that it has already taken steps to correct some of the problems outlined in the GAO report, which contains the FDA response.

Consumers who have been injured after taking prescription medications may be able to take legal action against the drug’s manufacturer. There may be class actions or multi-district litigation when hundreds or thousands of consumers have received similar injuries after having taken the same drug.