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Is the FDA doing enough to protect the public from potentially serious drug side effects?

According to a recently released Government Accountability Office (GAO) report, it doesn’t look like it. Though the administration approved many drugs between 2006 and 2014 through their “fast-track” processes, the GAO report found that it failed to properly track side effects associated with those drugs once they were on the market.

The lack of an efficient tracking system may be leaving patients at risk, as with fast-track approvals, many safety issues don’t emerge until after thousands of patients take the drugs. “The GAO report clearly highlights that FDA is not doing its due diligence in tracking drug safety issues and post-market studies that are critical in ensuring patient safety,” said Congresswoman Rosa DeLaura (D-Conn.).

GAO Takes Issue with FDA’s Fast-Track Approval Processes

The GAO conducted the study in the first place because it was “asked to provide information about FDA’s expedited programs and its postmarket monitoring of expedited and nonexpedited drugs.” The investigation was conducted at the request of DeLaura.

Over the years, critics have pointed to the FDA’s fast-track approval processes as contributing to patient injury several times. The 510(K) approval process, for example, does not require drug companies to conduct clinical trials on certain medications or medical devices. Instead, the manufacturer must only prove that the product is significantly similar to one already on the market.

Several products that have been approved this way have been linked to substantial safety issues. Metal-on-metal hip replacements are an example. Approved through the 510(k) process, injured patients have alleged that they were never adequately tested, and ended up causing injury to thousands of patients. It was such a significant problem that in 2013, the FDA issued a safety communication warning that metal-on-metal hip implants “have unique risks in addition to the general risks of all hip implants.”

The GAO acknowledges that expedited approval programs are used when there is “an unmet need for the treatment of a serious condition,” and patients stand to benefit from getting a drug or device to market quickly. A number of the drugs ushered quickly to market are to treat cancer, for instance. In these situations, however, the FDA is responsible for monitoring the safety of those drugs once patients are taking them—and it’s there that they’re falling short.

FDA Late On Reviewing Post-Marketing Studies

According to the GAO’s report, about a quarter of the drug applications approved for market between October 2006 and December 2014 used at least one expedited program. In many of these cases, the FDA required the manufacturer to perform additional safety studies on the drugs once they’re on the market. Yet the administration apparently lacks the processes and resources needed to obtain readily accessible data on post market safety.

The GAO found that between 2008 and 2013, the FDA received 1,400 follow-up studies that it had requested from manufacturers. It also found that it was late in reviewing more than half of them. Those studies could contain data related to potentially serious side effects. It is critical for the FDA to review the reports in a timely manner, so they can spot any safety issues and take action to protect patients.

This has been an ongoing problem. According to the STAT, similar results were reported in 2008, when an independent contractor found more than 500 postmarket studies that had not been reviewed by FDA staff.

The FDA also revealed that it had failed to upload to its tracking system the majority of the potential safety issues identified by staffers. According to the GAO, the FDA blamed the “high workload” of their review staff. With inaccurate or incomplete data, however, it is difficult to properly identify safety issues. The GAO also noted that the FDA had failed to post quarterly reports listing potential safety issues, despite a statutory requirement that it does so.

The FDA responded to the report, stating that it was taking steps to update their tracking system and quarterly reports. The FDA also added that it had issued advisories and warnings for drugs showing signs of serious risk.

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