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Government Office Expresses Concern With FDA Drug Oversight


The federal Food and Drug Administration (FDA) is tasked with the tremendous responsibility of keeping American consumers safe from dangerous drugs and medical devices.

Accordingly, the agency has not only implemented strict pre-market testing and screening measures for new products, but it is required to monitor the products after their introduction to the marketplace. More specifically, the FDA is supposed to keep detailed records of adverse reports, as well as keep track of follow-up studies on some of the more controversial drugs – tasks which investigators believe may be falling to the wayside.

Lack of FDA oversight

In December 2015, the Government Accountability Office (GAO) issued a comprehensive report entitled “FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement.” The report focused primarily on the FDA’s “fast-track” approval processes, which are often implemented either when there is an urgent need for a drug (e.g., life-saving vaccines) or a certain drug has been approved in the past in a substantially similar form.

While the fast-track option may be necessary to help save lives and mitigate the spread of disease, it can also lead to potential problems in the event a certain medication causes unforeseen side effects.

Accordingly, the GAO was asked to evaluate the following with regard to fast-tracking:

  • The number and types of requests for fast track or breakthrough therapy designation;
  • The number and types of FDA-approved drug applications that used an expedited program, and;
  • The extent to which FDA’s data on tracked safety issues and postmarket studies allowed the agency to meet its reporting and oversight responsibilities.

To evaluate this information, the GAO reviewed data pertaining to nearly 1,000 applications for fast-track approvals submitted between October 1, 2006 and December 31, 2014.

Of the approximately two-thirds that were approved by the FDA, the GAO concluded that the FDA lacked “reliable, readily accessible data on tracked safety issues” and lacked a safe level of post-market oversight.

Dangerous drugs fast tracked to market

Among the “fast-tracked” drugs reviewed in the GAO’s study, the highest percentage were oncology medications designed to treat malignancies caused by cancer. However, the study included a broad range of medications across nearly every area of medicine – including some of the more common drugs used by millions of Americans today.

In fact, some of the most commonly fast-tracked drug types include:

  • Anti-viral medications
  • Anti-infective
  • Cardiovascular and renal treatments
  • Psychiatry
  • Neurology

Most notably, the GAO took exception to the FDA’s significant delays in reviewing over 1,400 post-market studies, many of which could possibly highlight post-market issues with drugs and devices that were not known prior.

Dangerous drugs – especially those offered fast-track approval – can present a significant risk of injury or death for patients who are unaware of the potential side effects. Oftentimes, lawsuits are premised on the notion that the plaintiff took a prescribed course of medication without ever being made aware of the inherent dangers, resulting in injuries and complications. Mainstream medications such as Xarelto and Actos were fast-tracked to the market, and both have been associated with life-threatening side effects.

With the added data uncovered by the GAO’s study, it may be possible that certain drugs are simply understudied and unsupervised after being introduced to the market – creating a hazardous situation for patients and consumers alike.

  1., FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement,
  2., Gov't Watchdog: Many Gaps in FDA's Oversight of Drug Safety,