Drug Side Effects Not Being Adequately Monitored By FDA: GAO Report

A federal government oversight report indicates that the FDA is failing to adequately track side effects of drugs after they hit the market, raising questions about whether the agency is approving drugs before they have been adequately tested. 

The Government Accountability Office (GAO) issued a report on drug safety (PDF) last month, determining that the FDA was approving too many drugs via fast-track approval processes and then failing to monitor those drugs’ effects on patients to ensure they are actually safe. The report was commissioned by U.S. House Representative Rosa DeLauro of Connecticut.

According to the report, since 2007 the FDA has received more than 770 requests for drugs to be given fast-track approval designations. The agency has approved two-thirds of those requests, the GAO found. In all, about a quarter of drugs approved from October 2006 to December 2014 used some form of expedited program, the report indicates.

Those approvals typically come with postmarketing requirements, indicating that the drug will be closely watched once it hits the market, to see whether any serious adverse drug side effects begin appearing among its users. However, the GAO said those requirements are not being met.

“FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systemic oversight,” the report found. “Internal control standards for federal agencies specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes. However, evaluations conducted by CDER (Center for Drug Evaluation and Research) of data in its database revealed problems with the completeness, timeliness, and accuracy of the data.”

The findings are similar to warnings issued in a report released by the Institute of Medicine of the National Academies in 2012, which found that the agency’s current approach to drug oversight after medications are approved is not sufficient and does not ensure that the benefits and risks of drugs are consistently monitored over the life cycle of the product.

While the FDA has said it is working on fixing the problem and that its postmarketing surveillance of drugs is improving, the report points out that most of the possible drug safety issues the FDA already identified as potential problems were not being tracked through the FDA database. This could be because of the nature of the software the agency uses to update that data, which the review found to be problematic and likely made it harder for staffers to enter data.

The report comes at a time when the agency and pharmaceutical companies have called for ways to make it easier and cheaper to get new drugs on the market.

“FDA has supported efforts to shorten development and streamline the agency’s review of drug applications through expedited pathways,” GAO investigators noted. “However, we found problems with the agency’s efforts to oversee and track potential safety issues and postmarket studies once those drugs were on the market. FDA’s data on postmarket safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systemic analysis difficult.”

The GAO report recommended that the FDA have ready access to complete, timely and accurate information and called for the agency to begin additional oversight on drugs to protect public health and allay growing public fears over the safety of their drugs.

GAO investigators called on the Commissioner of the FDA and the Secretary of Health and Human Services to develop comprehensive plans to better track postmarket study data, and to work with stakeholders to improve the FDA’s database or make future technology investments that can be more easily stored and accessed by FDA staff.