Drug Pushing

Usually known as a consumer advocate, Sen. Paul Wellstone is backing a bill that would lower standards and ease safety measures on manufacturers of drugs and medical devices.

PAUL WELLSTONE HAS won the respect of consumer groups, but apparently not their trust. Minnesota's senior senator is the target of a media campaign by Public Citizen and other consumer groups who are blasting him for supporting a Food and Drug Administration reform bill making its way through the Senate.

In the Labor and Human Resources committee, Wellstone voted for the bill, which would radically change the way the FDA does business, making it easier for companies to win approval for new medical devices. Supporters say the measure will save lives by getting new technology into use faster. But critics call it a "Christmas tree piled with goodies for drug and medical companies that improves profits in an already booming business while putting peoples' lives in danger."

"Sen. Wellstone, who usually speaks for consumers, is abandoning his constituents on this legislation," says Public Citizen's president, Joan Claybrook. "I guess this grab bag of goodies is what $33.5 million in campaign contributions (to Congress) from the pharmaceutical and medical device industries over the past six years can buy."

The bill, written with the help of the medical industry, lowers product testing standards, eliminates some FDA-run tests, makes it easier for doctors to use non-approved treatments, and for food companies to make health claims about their products. Similar "reforms" were shot down in the last Congress. So this time around, supporters tied the measures to the renewal of a popular law, the Prescription Drug User Fee Act (PDUFA), which drug companies, lawmakers, and FDA officials want to keep alive. PDUFA requires companies to help the FDA pay for testing new drugs. The extra money has helped the FDA hire 600 new reviewers and cut the time it takes to approve new drugs from 29 months to just 15. PDUFA expires in September, and the ticking clock puts Wellstone and other senators in the uncomfortable position of supporting the baggage piled onto a good idea.

Wellstone's office says his vote in the committee won't automatically translate into a yes vote on the Senate floor. He's written the bill's author, Vermont Republican James Jeffords, about his concerns. "The way the process works here is there's always going to be lots of debate, lots of open communication and strong feelings," says Wellstone's press secretary, Linda Marson. "That's the way that the process works, the negotiations continue, we're talking to the groups to make sure the bill contains adequate consumer protections."

One of the 73 groups opposing the bill is the Minnesota AIDS Project. HIV groups were leaders in getting the PDUFA law passed, but say this bill would make it too easy for drugs to get approved. The law would allow drug approval after one set of clinical tests instead of two, as is now the case. Bob Tracy, Minnesota AIDS Project public policy director, says activists convinced the FDA to approve some drugs after one test, but adds that making this the rule rather than the exception would be a mistake.

Additionally, U.S. Health and Human Services Secretary Donna Shalala says parts of the bill "would undermine the public health protections that the American people now enjoy." Her department opposes allowing medical device makers to hire private product testing companies instead of having the FDA do the research on everything from bandages to pacemakers and artificial limbs. An FDA pilot program is using outside reviewers to test less complicated devices, but the agency doesn't believe it would work on a large scale.

Public Citizen sees the provision as a seedbed for corruption. "It's not rocket science to figure out that companies are only going to go back to reviewers that give them the answer that they want," says Public Citizen spokeswoman Maura Kealy. "And reviewing firms are not going to stay in business if companies don't come back with repeat business." Both consumer groups and the FDA would like to see manufacturers follow the path of drug companies and help fund quicker FDA tests.

Wellstone also opposes outside testing, but his opposition isn't enough for the bill's enemies. They hope to pressure Wellstone to lead the fight to renew PDUFA and delay debate on the other issues. "The only critical thing here is PDUFA. None of the rest of this has to be acted on right now," says Tracy. "We need some public hearings on it and we should find a way to alter the process to make that happen."

 
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