FierceHealthcareFierceHealthITFierceHealthFinanceFierceEMRHospital ImpactFierceMobileHealthcare   FiercePharma

GAO to study FDA's post-approval review process

Tools
Tags
Food and Drug Administration (FDA)
Charles Grassley
heart attacks
drugs

Prompted by calls from Sen. Charles Grassley, the Government Accountability office has set plans to review the current method by which the FDA approves some drugs, including challenged medications like diabetes drugs Avandia and cholesterol drug Vytorin. Right now, the agency bases some approvals on "biomarkers," measurable responses in patients which are believed to predict other outcomes. For example, Avandia was approved because it lowered blood sugar, which was believed to lower heart attack risk, a much quicker route than waiting years to see if patients actually had the heart attacks. Since then, however, research has suggested that Avandia actually raises such risks.

Advocates say using biomarkers is appropriate for several reasons. Among other things, they say the longer trials needed to actually find events like heart attacks might jeopardize patients, as some would have to take a placebo for long stretches. Meanwhile, some critics say using biomarkers isn't necessarily the problem. They contend that the real concern is that the FDA doesn't require follow-up studies which would investigate whether drugs like Avandia and Vytorin delivered on their promised benefits.

To learn more about this issue:
- read this Associated Press piece

Related Articles:
Biotechs eager for FDA approval of biogeneric drugs. Report
FDA streamlining drug approval process. Report
Researcher challenges FDA approval process. Report
Report faults FDA's post-marketing vigilance. Report

Bookmark and Share
Get Your FREE FierceHealthcare Email Newsletter:
Be the first to comment

Comments

Post new comment

The content of this field is kept private and will not be shown publicly.

More information about formatting options

To combat spam, please enter the code in the image.