News & Resources

October 1, 2009. Category: Product Liability, Unsafe Drugs

FDA’s Oversight of Post-Marketing Studies Inadequate

The Government Accountability Office (GAO) has released a new report about the FDA’s lack of post-marketing oversight in a number of the drugs which it conditionally approved.

The FDA normally makes a decision to approve a drug based on clinical trials. If the clinical trials yielded favorable results, the FDA would then likely approve the drug and sales of the drug can be introduced to the U.S. market. The downside to this traditional route, though, is that the clinical trials can take years to complete, and cost the pharmaceutical company millions of dollars.   With this in mind, in 1992 the FDA instituted an optional route to approval: surrogate end-points. Surrogate end-points are the end-results yielded by a drug in a laboratory setting which tend to show positive health benefits. For example, HIV-related drugs are often approved based on its virus-lowering power, a major factor in increased survival for HIV-infected patients. A cholesterol drug could be approved to prevent heart disease, an end-point, by showing that the drug lowers cholesterol – since there is a connection between high cholesterol and heart disease. Utilizing this approval route means that manufacturers can get their drugs to the market faster and patients in need have faster access to the drug.

Unfortunately with surrogate end-point approval there are often many factors unknown, namely long-term effects of the drug’s usage. Long term clinical studies provide this information, but drugs using surrogate end-point trials are often approved so quickly that long-term effects are not known until the drug is on the market - which means that adverse effects may not be known until after the drug’s approval. As such, the FDA approves these drugs conditionally. This means that the FDA will require the manufacturer to conduct ongoing research beyond the drug’s approval, or else the drug’s approval will be revoked.

Despite all of these conditionally approved drugs requiring the conduction of post-marketing studies, the GAO found only 52% of these drugs actually have adequately completed them. 18% haven’t even started, 7% were still ongoing, and 2% were delayed. The remaining 21% were either not yet reviewed or found no longer necessary.

The GAO also noted the FDA’s inability to provide accurate record keeping of post-marketing research. Also, the GAO found that no drug approved under the surrogate-endpoint system has ever been unapproved, despite a large number of delinquent manufacturers.

This is not the first time the FDA has come under fire from the GAO. In 2006, the GAO chastised the FDA for its lack of a clear oversight process, and inability to quickly evaluate post-marketing data.  Clearly, the FDA has a responsibility to demand post-marketing studies be completed and submitted to prove a drug’s long-term safety and efficacy.

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