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The GAO Report: FDA Failed to Properly Track Postmarket Drugs Trials

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Maina Mehrotra2 years ago

According to a report by the General Accountability Office (GAO), the US Food and Drug Administration (FDA) has not been properly tracking the clinical effectiveness or safety of drugs approved under their expedited process once the drugs are released into the market.

About the FDA’s Center for Drug Evaluation and Research (CDER)

“FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight.” – GAO Report as published by Medscape

The FDA's CDER has four programs — accelerated approval, priority review, fast-track designation, and breakthrough therapy designation— meant to expedite the approval of new drugs. 

Medications treating serious conditions, which can be expedited through the latter two programs, need formal requests sent to CDER for grants to expedite. When a drug is expedited, it has not undergone the standards review process, meaning there is less known about any adverse effect or clinical benefits of the drug. 

The FDA can ask for a postmarket study from drug companies. If a drug receives the expedited approval, the clinical effectiveness and adverse effect must be studied and reported on. If the drug company fails to do the postmarket study, the drugs approval is supposed to be withdrawn by the FDA.

Postmarket Study Data in CDER's Database Outdated and Inaccurate

There are serval important steps the FDA is required to complete concerning the status of postmarket studies. Firstly, they must publish an annual report in the Federal Register. Secondly, the FDA has to maintain a database listing potential safety issues, the Document Archiving, Reporting, and Regulatory Tracking System (DARRTS), an internal database. Lastly, a quarterly report listing the safety concerns posted in DARRTS must also be published. 

Postmarked study data in CDER’s database was found by the GAO to be outdated and inaccurate.The challenges of data entry and the requirements for conducting structured reviews of postmarket studies maybe the reason behind the outdated and inaccurate data in DARRTS.

Not only that, but the agency's tracking software was found to be insufficient. 

It was recommended by the GAO, that the Department of Health and Human Services order the FDA commissioner to form an all encompassing plan to find all the issues and upgrade the information technology system. 

However, the Department of Health and Human Services did not find it necessary to place the expedited drugs under harsh scrutiny on safety issues, once they are in the market.

In response, the GAO noted that the FDA lacks the important information on whether the drugs  “pose additional safety risks to patients once they are on the market.”  

Statistics and Information on Expedited Approval

The FDA granted about 525 out of 772 (two-thirds) requests for the fast-track designation program from 2006 to 2014. That number has increased from 54 in 2011 to 89 in 2014 the GAO noted.

On the other hand, the FDA has denied 120 of 225 requests for breakthrough therapy designation program from July 2012 to the end of 2014. There were 71 requests granted, but the rest were withdrawn. 

The most common types of products granted for the fast-track or breakthrough therapy designation were the antiviral and oncology drugs.


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