Quoted from http://www.reuters.com/article/idUSTRE63R5UK20100428
Critics cite Avandia in pushing FDA safety reforms
Wed Apr 28, 2010 5:36pm EDT
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.