Congress to press FDA over drug safety woes

By Lisa Richwine

WASHINGTON (Reuters) - The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.

Lawmakers will examine this week how the FDA and manufacturer GlaxoSmithKline Plc handled data that suggested the pill Avandia might raise the chances of having a heart attack.

The controversy comes as Congress considers legislation meant to bolster the FDA's oversight of drug side effects. Some critics are using the Avandia case to try to build support for tougher safeguards.

On Wednesday, a U.S. House of Representatives committee will question FDA Commissioner Andrew von Eschenbach, London-based Glaxo's research and development chairman, Moncef Slaoui, and Cleveland Clinic cardiologist Steve Nissen, who wrote an analysis linking Avandia to a 43 percent higher chance of having a heart attack.

Chairman Henry Waxman, in a letter to von Eschenbach, said the hearing's goal was "to assess the FDA's role in evaluation of the safety of Avandia." The California Democrat asked for a timeline of actions, communications with Glaxo, and internal analyses related to the drug's heart safety.

After Nissen's study was published by the New England Journal of Medicine last month, the FDA said its own preliminary evaluation put the heightened risk around 40 percent, while Glaxo estimated 30 percent. The company said it provided the information to regulators in August 2006.

Some critics question why neither the FDA nor Glaxo alerted patients while officials kept investigating.

Both say they did not publicize the finding because other studies provided conflicting evidence.

Nissen admitted his research had several limitations, and Glaxo said people overreacted as the chances of having a heart attack were still small at about 0.6 percent if patients took Avandia or not.

Still, the findings sparked a new outcry from members of Congress who have blasted the FDA in recent years as being slow to respond to problems with Merck & Co Inc.'s withdrawn arthritis drug Vioxx and other medicines.

The Senate passed a bill in May to give the FDA more power over drugmakers, including the ability to require post-approval studies and additional warnings for new medicines.

Patient and consumer groups said they met with House staff this week and explained how a variety of additional measures might have set off alarms about Avandia sooner.

Some are pushing for an approach championed by Iowa Republican Sen. Charles Grassley that would give more independence and power to the FDA office that watches for side effects after approval.

"I think (the Avandia case) is a big help in encouraging the House to pass a really good, strong bill," said William Vaughan, senior policy analyst for Consumers Union.

Millions of patients take Avandia, known generically as rosiglitazone, and sales topped $3 billion last year.