Government Report Finds FDA Is Doing A Bad Job Tracking Drugs

By Victoria Kim 01/25/16

Rep. Rosa DeLauro started an investigation into the government agency.


It may come as no surprise, but a new investigation of the Food and Drug Administration has brought to light the agency’s inefficiency when it comes to tracking drugs after they go on the market.

The report, released by the Government Accountability Office, was commissioned by Rep. Rosa DeLauro to investigate the FDA’s record on keeping tabs on post-market safety issues with new drugs. This is especially relevant in a time when increasing numbers of them are being approved under an expedited process.

As the highest authority on the safety and effectiveness of drugs sold in the United States, the FDA is responsible for monitoring drug safety and overseeing how the drug is doing in the marketplace, including any problems with the drug that may arise.

But according to the report, the agency is having trouble keeping track of the drugs. “The FDA’s data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systemic analysis difficult,” the report concluded.

Issues with data entry (a result of an inefficient computer system) and a backlog in the review of reports from drug makers' post-market studies were among the agency’s flaws. Over half of such reviews were overdue.

And the majority of potential safety issues identified by the FDA were not being tracked in its computer database for drug safety tracing.

The FDA may use one or more of its expedited programs to fast-track drugs to market when there is an unmet need for the treatment of a serious condition. About a quarter of the drugs the agency approved from October 2006 to December 2014 were approved through at least one of the agency’s expedited programs.

When it comes to drugs that have been fast-tracked through the approval process, it is particularly important for the FDA to monitor these drugs once they reach the market, the GAO notes in the report, as there may be a “greater potential for previously unrecognized safety issues to appear once a drug is more widely used.”

Advocates of the fast-track process, which was established in the midst of the HIV crisis to get medicine to patients quickly, say it is increasingly important as science is rapidly advancing. The opioid overdose antidote naloxone is one example of a drug that was fast-tracked to market.

However, the fast-track option is harder to defend if the FDA is not effectively monitoring potential problems with new drugs after they are made available to the public. The GAO recommends the FDA develops a plan to correct any inefficiencies in logging post-market safety data to ensure it can be easily used for oversight.

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