Lawmakers Take a Hard Look at FDA, Drugs

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As many on Capitol Hill push for an overhaul of U.S. health care, the Food and Drug Administration may be an early target. Members of Congress are taking issue with how the FDA monitors new drugs and how much it is influenced by the drug industry.

RENÉE MONTAGNE, host:

This is MORNING EDITION from NPR News. I'm Renee Montagne. There could be big reform at the Food and Drug Administration. That's what members of Congress seem to think it needs, and they have the power to make it happen. In the new Congress's first hearing about drug safety and the FDA, there was a bipartisan clamor for fundamental change.

Here's NPR's Joanne Silberner.

JOANNE SILBERNER: Senators almost never cross Capitol Hill to testify at House subcommittee hearings. But yesterday, Republican Chuck Grassley of Iowa did. He's that angry about all the things he says are wrong with the FDA.

Senator CHARLES GRASSLEY (Republican, Iowa): First, scientific dissent is discouraged, squashed and sometime muzzled inside the FDA. Second, the FDA's relationship with drug makers is too cozy.

SILBERNER: And he had more complaints. FDA employees are afraid to voice their views publicly and the agency won't make data public. Committee members piled on.

Senator JOHN DINGELL (Democrat, Michigan): FDA is badly broken.

Representative BART STUPAK (Democrat, Michigan): The FDA's ability to ensure a safe drug supply has been greatly compromised.

SILBERNER: That was John Dingell and Bart Stupak, both Democrats of Michigan. The hearing centered around how the agency handled the antibiotic drug Ketek. The FDA approved it in 2004, despite a study that contained fraudulent data. Earlier this week it backtracked, qualifying its previous endorsement. Vioxx came up too. That drug had to be yanked from the market. David Graham had some ideas about how to fix things. He's an FDA employee and whistleblower who was subpoenaed by the committee and was careful to say he wasn't speaking for the agency.

Mr. DAVID GRAHAM (Employee, Food and Drug Administration): If you really want to change the outcome, if you want Vioxx not to happen again and you want Ketek not happen again, you need to work on the structure. You need to focus on how are decisions made.

SILBERNER: Graham said the FDA office that studies drugs after they're on the market needs to be given more authority to take action when it notices problems. There's a good reason to think Congress will step in at some level as early as this summer. That's when the law that provides FDA with a lot of its operating funds expires. Under that law, $305 million of the agency's budget comes from drug companies which pay to have certain products evaluated. The FDA would like to increase those fees by another $87 million. The companies aren't balking. In fact, the pharmaceutical trade group has signed off from the plan. Alan Goldhammer is with that group.

Mr. ALAN GOLDHAMMER (Pharmaceutical Research and Manufacturers of America): This will buy increased access to drugs safety databases, provide more medical officers to the office that reviews post-market drug issues.

SILBERNER: And in general, he says, the agency would have the money to do the things it needs to do. But others say it's a bad idea to increase the FDA's dependency on drug company funding. Jerry Avorn is with Harvard Medical School and author of a book, "Critical of the FDA."

Dr. JERRY AVORN (Harvard Medical School) The best solution would be to no longer have the industry being regulated to pay the bills of the agency that regulates them. We don't do that for most other government agencies, and it probably will be a good idea to stop doing that with FDA and the drug industry because many people within the FDA say that it has changed the climate there to make the FDA people feel like they're basically working for the drug company.

SILBERNER: Still, Avorn suspects some form of the funding plan will pass this year. It is, after all, cheaper for Congress to let industry pay its way. The FDA responded to yesterday's hearing with a written statement saying it's already beefed its safety testing, among other things, and it looks forward to making its own case before the committee soon.

Joanne Silberner, NPR News, Washington.

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