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KAI RYSSDAL: You get sick in this country, a remedy’s usually not too far away. The pharmaceutical industry’s tried to help with that, so has Congress. Federal laws passed more than a decade ago encouraged development of leading edge drugs, as well as a way to get them on the market faster. Some of them, though, didn’t work out so well. Anybody remember Vioxx? A study out today says that fast track process compromises safety.
From the Marketplace Innovations Desk at North Carolina Public Radio, Janet Babin reports.
JANET BABIN: Say you’re diagnosed with cancer and there’s a breakthrough drug that doctors think could save you. You’d want it right away. Well, the “fast track” laws enacted in 1992 let the FDA speed up the approval process to just six months, but the study found that fast track FDA decisions can cause trouble later on.
JERRY AVORN: These decisions are much more likely to result in drug withdrawals or new safety problems that were not anticipated.
Dr. Jerry Avorn at Harvard Medical School co-authored the paper. It will be published in the New England Journal of Medicine. He says fast track drugs get recalled five times more often than standard drugs, but the FDA has a problem with the Harvard team’s data. Here’s the Agency’s Clark Nardinelli.
CLARK NARDINELLI: We tried to replicate what they did, and we came up with very different numbers, which led us to think that their conclusions don’t hold up.
Avorn stands by his data. He says what doesn’t hold up is the FDA’s funding model.
AVORN: About half of the budget for FDA’s scientists who review drugs does indeed come from the drug industry.
The authors say that creates the sense that the FDA works for big pharma, and calls into question why some drugs, like Vioxx, are fast tracked and others aren’t. Analyst Les Funtleyder at Miller Tabak hopes the study won’t slow down the approval process.
LES FUNTLEYDER: The issue isn’t so much that we need more regulation, it’s that the FDA needs more staff.
The FDA said today, it does not approve drugs before they’re ready.
I’m Janet Babin for Marketplace.
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