Congressional Appropriations Subcommittee slaps FDAs wrist

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FDA is under scrutiny from Congress. Source: Truthdig  

The Government Accountability Office (GAO) is going to investigate whether the FDA’s drug-review process cleared two popular medications, the cholesterol drug Vytorin and the diabetes pill Avandia, without sufficient proof of their safety or efficacy.

The Washington Post reported that on March 4, Sen. Charles E. Grassley, R-Iowa, requested that the GAO investigation after recently released studies on the two drugs suggested that Avandia and Vytorin may not lower the risk of heart attack and artery-clogging plaque, as assumed by patients and doctors.

“There’s enough of a pattern of problematic drugs to ask for an independent review of how the FDA follows up on the effects of medicines that it’s approved,” Grassley said.  The question is whether the FDA should approve drugs based on biological measures, such as cholesterol and blood sugar, without evidence that they improve more meaningful measures, such as survival.

In a separate hearing on Feb. 27, Rep. Rosa DeLauro, D-Conn., chairwoman of the Congressional Appropriations Subcommittee that funds the FDA, told FDA authorities that a lack of money is no excuse for the FDA to not enforce drug safety laws.

“The FDA has been starved for resources under seven years of the Bush administration,” DeLauro said in her opening statement. “But increased funding is only part of the challenge. Funds alone cannot fix an agency that routinely fails at its most basic responsibilities — keeping track of clinical trials, preventing conflicts of interest, following up on critical investigations. Sixty-five percent of postmarket studies on new medications have not yet begun. This startling fact makes it clear that we have a long way to go.”

DeLauro and other subcommittee members questioned FDA Deputy Commissioner Janet Woodcock and David Horowitz, deputy associate commissioner for compliance policy in the FDA’s Office of Regulatory Affairs, about FDA inspections of drug manufacturing facilities.

Citing a Government Accountability Office report that identified problems with inspections of foreign facilities in March 1998, DeLauro said, “From 2001 to 2008, we provided a 62 percent increase in [Center for Drug Evaluation and Research’s] budget. During that time, foreign inspections dropped 30 percent and domestic inspections dropped 17 percent. That’s the result of a decision by the agency.”
Horowitz said that the FDA had 232 inspectors who went to 300 foreign manufacturing facilities, approximately 10 percent of the total facilities, in 2007 and visited 1,200 domestic manufacturing facilities.

When questioned by Rep. Steven Rothman, D-N.J., Woodcock said hiring additional inspectors would be a top priority for the agency if money were not an issue, but she could not say how many would be needed.