Critics cite Avandia in pushing FDA safety reforms

WASHINGTON (Reuters) - The controversy surrounding a GlaxoSmithKline Plc diabetes drug points to a need for changes in the way the U.S. Food and Drug Administration handles safety issues, agency critics told lawmakers on Wednesday.

The FDA is taking a new look at the safety of Glaxo’s Avandia pill, which carries a warning about heart risks. The manufacturer says the drug is safe and effective, and the FDA is advising patients to keep taking the drug as directed.

Two drug safety reviewers have recommended that the drug come off the market after concluding it was more dangerous to the heart than rival drug Actos by Takeda Pharmaceutical Co Ltd.

That has prompted new calls for more independence and power for the reviewers who analyze a drug’s risks after it reaches the market, an idea circulating for years. Critics say more authority lies with the staff who approve drugs and are therefore reluctant to withdraw a medicine they supported.

“Individuals in the office responsible for post-market surveillance should be allowed to provide an independent opinion based on the best available evidence,” Republican Senator Charles Grassley told a House of Representatives Appropriations subcommittee.

The FDA has said it is undertaking an internal review of drug safety decision-making in addition to bringing Avandia to an advisory panel of outside experts in July. “This review will make recommendations regarding the agency’s approach to safety issues including Avandia,” FDA spokeswoman Karen Riley said on Wednesday.

A panel that met in 2007 heard from a safety reviewer who felt the drug should no longer be sold. That panel voted 22-1 that Avandia was safe enough to stay on the market.

Representative Rosa DeLauro, the subcommittee’s chairwoman, said the “evidence suggests that we should look into strengthening either the independence or the powers of the FDA’s drug safety office so that its recommendations no longer go unheeded.”

DeLauro said she wanted to provide input to the FDA ahead of the July advisory panel meeting. She also said she might pursue FDA safety reforms when her panel is setting funding levels for the agency.

“We would like to address some of these issues,” she said.

Another witness at Wednesday’s hearing, Dr. Harlan Krumholz, said drugmakers should disclose more clinical trial data so independent researchers can evaluate it.

Companies must release summaries of study results but should also provide raw data with more details, Krumholz said.

“I still don’t think we know the full story (on Avandia). We have not seen the raw data,” said Krumholz, a Yale University cardiologist.

Drugmakers said in a statement the FDA already looks at the raw data. “An independent analysis of the raw scientific data already occurs” as part of the FDA review process, said David Wheadon, a senior vice president at the Pharmaceutical Research and Manufacturers of America.

The FDA scientists are “best equipped” to evaluate the drug benefits and safety and often turn to outside experts on advisory panels for input, Wheadon said.

On Avandia, the FDA decided in 2007 Avandia should carry a warning, saying a review of 42 studies associated the drug with an increased risk of a heart attack or chest pain compared with a placebo. But it said overall data were “inconclusive.”

Avandia returned to the spotlight in February after Grassley and Senate Finance Committee Chairman Max Baucus released internal FDA documents and a report that criticized the handling of the drug by Glaxo and the FDA.

Sales of Avandia topped $3 billion in 2006 but fell to $1.2 billion in 2009.

In a statement, Glaxo said it “stands behind the safety and efficacy of Avandia when used appropriately” and that “the totality of new and existing data” on the drug’s safety would be presented at the July panel meeting.

The company also has said it has been open about providing information on the drug to the FDA.

DeLauro said she did not invite the FDA or Glaxo to the hearing because they are preparing to address Avandia at the July panel meeting.

Reporting by Lisa Richwine; Editing by Steve Orlofsky