FDA faces more scrutiny amid new warnings on diabetes drug

Troubling questions about the safety of a widely used diabetes medication have given more ammunition to Democrats seeking tougher drug-safety legislation.

Key House Democrats and their staffs yesterday were still digesting the disclosure on Monday that GlaxoSmithKline’s Avandia may be associated with a significantly increased likelihood of heart attacks and other fatal cardiovascular side effects.

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The New England Journal of Medicine published the critical review of studies on Avandia, which was followed immediately by a Food and Drug Administration (FDA) safety alert. The news plays into the hands of lawmakers and consumer advocates who contend that the FDA lacks the authority to ensure that drugs already on the market are safe.
Some of these critics say the pending bill does not go far enough to address the agency’s shortcomings.

Moreover, the apparent fact that the FDA itself already was aware of Avandia’s  safety issues has raised questions about whether the agency acted properly by waiting to issue warnings to doctors and patients until an outside analysis came to light.

Closed-door negotiations among the Democratic members of the House Energy and Commerce Committee on the FDA bill have been taking place for months. The panel already has convened a series of hearings on the FDA and the safety of prescription drugs and medical devices, and it is expected to begin marking up the bill soon after the House returns from
Memorial Day recess.

A spokeswoman for the Energy and Commerce Committee said that the chairman and the staff were still reviewing the study, conducted by the Cleveland Clinic, as well as the FDA’s actions. “It’s something we’re carefully considering” as the panel gets closer to marking up its FDA bill, she said.

On Monday, Energy and Commerce Committee Chairman John Dingell (D-Mich.) issued a written statement strongly criticizing the FDA and vowing action. “Regrettably, it is incidents like this that demand legislative changes in the way FDA deals with drug safety. The committee will address these dangerous shortcomings while writing legislation to reauthorize [the Prescription Drug User Fee Act],” Dingell said.

The underlying bill, considered must-pass by the Democratic leadership, the administration and the pharmaceutical industry, would reauthorize two programs though which prescription drug makers and medical device manufacturers, respectively, pay user fees to the FDA for reviews of their new products.

The Energy and Commerce Committee is expected to add language beefing up the FDA’s authority to monitor drugs already on the market and force corrective actions when safety concerns arise. But it has not determined the extent of that authority.

The Senate passed its version of the bill two weeks ago with only one dissenting vote after Health, Education, Labor and Pensions (HELP) Committee Chairman Edward Kennedy (D-Mass.) and ranking member Mike Enzi (R-Wyo.) collaborated to appease various factions of their respective caucuses.

But a political firestorm over Avandia could undermine that delicate compromise, which expands the FDA’s drug safety authorities but stops short of stronger measures sought by some senators but opposed by the administration and the drug industry.

A Kennedy spokeswoman declined to comment on the Avandia article or the FDA’s actions on the drug.

On Monday, meanwhile, House Oversight and Government Reform Committee Chairman Henry Waxman (D-Calif.) reacted to the news on Avandia by announcing a hearing of his panel on June 6. Waxman invited FDA Commissioner Andrew von Eschenbach, GlaxoSmithKline chief executive Jean-Pierre Garnier and the Cleveland Clinic physician who was the lead author of the Avandia review, Steven Nissen.

Waxman, who also is a senior member of the Energy and Commerce Committee, has a long track record with FDA legislation and is the lead sponsor of a bill that would grant the FDA broad new authorities and enforcement powers.

Rep. Bart Stupak (D-Mich.), chairman of the Energy and Commerce Committee’s oversight subcommittee, vowed on Monday to get to the bottom of the FDA’s actions regarding Avandia. “The FDA is on notice that we have reached the end of our rope on their stonewalling of investigations into their failures to keep Americans safe from dangerous drugs and
poisonous foods,” Stupak said in a written statement.

Three weeks ago, Dingell, Waxman, Stupak and Sen. Chuck Grassley (R-Iowa) sent two letters to von Eschenbach seeking information on the safety of Avandia. Energy and Commerce Committee ranking member Joe Barton (R-Texas), Oversight and Government Reform Committee ranking member Tom Davis (R-Va.) and Rep. Ed Whitfield (R-Ky.), ranking member of the Energy and Commerce Committee’s oversight subcommittee, joined them on the second letter.

Although Kennedy has remained silent so far, two Senate colleagues have already begun an investigation into Avandia. Senate Finance Committee Chairman Max Baucus (D-Mont.) and Grassley, the panel’s ranking member, fired off letters Monday demanding answers from von Eschenbach and Christopher Viehbacher, the president of U.S. pharmaceuticals for GlaxoSmithKline.

The HELP Committee, rather than Finance, has jurisdiction over the FDA, but Grassley has been a frequent critic of the agency. While chairman of the Finance Committee, Grassley regularly used his oversight authority on Medicare and Medicaid, which spend billions on drugs, as a justification for investigating the FDA.