An Oversight Committee hearing on the diabetes drug Avandia brought new questions to the Food and Drug Administration just as the agency is about to face reauthorization of its drug approval program by the House.

The hearing was called in response to a New England Journal of Medicine study last month written by Cleveland Clinic cardiologist Steve Nissen. Nissen’s analysis of Avandia, known generically as rosiglitizone, concluded that the drug was responsible for greatly increased risk of heart attack and death in diabetes patients taking the drug.

Oversight and Government Reform Committee Chairman Henry A. Waxman, D-Calif., criticized the FDA’s drug safety process, saying the agency “dropped the ball,” in the case of Avandia.

“Avandia is a case study for the need for reform of our nation’s drug safety laws,” Waxman said.

Several Republicans did what they could to scuttle the hearing. Darrell Issa of California and Virginia Foxx of North Carolina accused Democrats on the committee of collaborating with Nissen prior to his study’s release to manufacture a scandal, an accusation Waxman denied.

Waxman was obviously irked, making a point of rapping his gavel and telling Foxx her time had expired just as she was thanking the chairman in the final words of her statement.

The FDA’s handling of Avandia drug safety issues is almost certain to become a topic as the House debates its FDA overhaul bill in a few weeks. The House is expected to pass a bill with far stricter drug safety provisions than were in a bill (S 1082) the Senate passed in May.

Waxman said before the hearing that he will offer his own, stronger drug safety bill (HR 1561) as an amendment to the FDA overhaul bill when it comes before the House. The bill would reauthorize the Prescription Drug User Fee Act, the program by which the FDA approves new drugs.

At other points, Republicans questioned Nissen’s methodology, known as a meta-analysis. A meta-analysis pulls together several studies to extrapolate data on a question that is not the focus of the individual studies being used. Meta-analysis is not considered as accurate as a dedicated study designed around a specific inquiry. Republicans used this fact to question whether Nissen’s study should really be the sole basis of concern.

Dr. Gerald Dal Pan, the director of the FDA’s Office of Surveillance and Epidemiology, gave a measure of credibility to Nissen’s analytic methods. At the hearing, he said the FDA did a re-analysis of a recent GlaxoSmithKline study in which the agency found the methodology lacking, and reached a similar conclusion to Nissen about Avandia’s cardiovascular risks.

While the FDA does not use meta-analysis to approve new uses for a drug or test its efficacy, Dr. John K. Jenkins, director of the Office of New Drugs, said the agency had in the past used meta-analysis to make a safety ruling and even pull a drug from market.

Rep. John Yarmuth, D-Ky., said FDA staff had briefed the committee before the hearing that if Nissen’s analysis proved accurate, it “would be a very big deal” and of great concern.

The FDA is still completing its final analysis of the drug’s safety, but since Nissen’s study was published, pressure has mounted from Congress to quickly re-evaluate the drug’s safety.

In FDA Commissioner Andrew von Eschenbach’s written testimony, he confirmed that two days after the publication of Nissen’s study the FDA had sent letters to GlaxoSmithKline and another maker of a similar drug instructing them to change the packaging on the drugs to include a “boxed warning” that would “more prominently address the risks of congestive heart failure associated with these drugs in certain patients.”