Senator Charles Grassley (R-IA) has asked the Government Accountability Office (GAO) to investigate how the U.S. Food and Drug Administration (FDA) follows through on drug approvals. The investigation comes at a time when an increasing number of approved drugs, such as Avandia, are later linked to serious injury or death.

The investigation

According to a press release on Senator Grassley’s website, http://grassley.senate.gov/, he has asked for an independent assessment of how the FDA follows up on the effects of medicines that it approves based on narrowly defined benefits. According to the Senator:

The way things have turned out with drugs like Vytorin and Avandia raise enough questions that a review is warranted. It’s not clear if the FDA’s own policies are being enforced internally, where the agency is supposed to require companies to perform follow-up studies. These policies are designed for patient safety. The public relies on the FDA to keep it safe from dangerous drugs and not just stick to narrow judgments that may not incorporate overall health.

Basically, the Senator is saying that the FDA does more on the front end and less on the back end – a practice that can have dire consequences to patients. He has asked that the GAO's inquiry 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.

The FDA has come under fire in the past few months for not being able to do its job and for allowing drug manufacturers a greater say in the approval process. If you’ve been injured due to a defective drug, contact an attorney whose practice focuses in this area of the law to discuss your options. To contact a qualified attorney, please click here.