GAO to Investigate FDA

Senator Charles Grassley (R-IOWA), known for his dramatic antic last June of marching over to HHS to demand answers about the FDA’s handling of the Ketek approval, has moved on to more substantive means to get information he wants for purposes of FDA reform.

CaplogoIn a letter issued last week, about which his office issued a press release yesterday, the Senator is asking the Government Accountability Office (GAO) to investigate approval and post-marketing practices at FDA.

The press release is vague and doesn’t really say much about what the Senator is seeking from the report.  The letter, however is far more insightful, using issues related to Vytorin and Avandia to raise questions about the FDA’s approval process using surrogate endpoints and about Phase IV commitments.

In the letter, excerpted below, he is asking several questions about Phase IV commitments – questions to which he must already know the answer:

The Food and Drug Administration (FDA) has approved several drugs that appear to have little to no effect in protecting lives and increasing health. For instance, FDA recently approved Genentech’s cancer drug, Avastin, to treat breast cancer.[1] Genentech’s studies showed that Avastin halted tumor growth, but that breast cancer patients did not live significantly longer than those that did not receive the drug. Surprisingly, FDA’s own advisory panel argued against the approval over concerns that Avastin’s benefits do not outweigh its toxic side effects.

Further, a study last year found that Avandia, which controls glucose levels, was associated with an increased risk of heart attack. And last month, Schering-Plough and Merck announced that Vytorin, which controls cholesterol levels, provided no benefit to cardiovascular outcomes.

In all three cases, these drugs were approved by FDA because they had an effect on surrogate endpoints (tumor growth for Avastin; glucose levels for Avandia; and cholesterol levels for Vytorin). However, none of these drugs were studied sufficiently to see if they added any benefit to the health and/or lifespan of the patient. Typically, such results can be found through phase IV trials.

Therefore, I request that the Government Accountability Office conduct an inquiry into the FDA’s approval of drugs based on surrogate endpoints, including an examination of FDA’s process to ensure that drugs approved on surrogate endpoints are both safe and effective. In particular, GAO’s inquiry should include an analysis of the following:

The number of drugs that were approved based on surrogate endpoints;

The surrogate endpoints that FDA uses to approve drugs;

For each of these drugs identified, the date each was approved and whether FDA required the companies to complete phase IV trials;

For each of these phase IV trials, the date they were started and the date they were completed and/or are expected to be completed;

Describe the tools that FDA has to compel companies to complete phase IV trials;

Describe any actions that FDA has taken against companies for failing to complete phase IV trials or failing to complete trials in a timely manner; and

Describe any additional powers that FDA may need to compel companies to complete phase IV trials, in the event the tools that FDA has presently are insufficient.

Why ask questions about post-marketing enforcement when it is pretty well-known that the FDA does not have authority to enforce Phase IV studies?  The answer is probably that he wants a document that will provide an official blueprint and basis for proposed reforms for the FDA.  No word available on when the study is released, but look for it if you want insight into the next cycle of FDA reform – at least from one member of the Senate.

(By the way, for anyone interested, the FDA’s CDER has a portion of the Web site devoted to the tracking the progress of Phase IV commitments.)   

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