Matthew Herper, 09.24.07
Forbes.com

You wouldn’t know it from the lack of fanfare, but the Food and Drug Administration is getting its biggest overhaul in a decade in a dramatic coda to Merck’s withdrawal of the blockbuster painkiller Vioxx three years ago.

A bill to give the FDA more power passed both houses of Congress with only a handful of no votes, and the president is expected to sign it into law. Because the bill is attached to the re-authorization of an important part of the FDA’s funding, a veto is unlikely. If the law doesn’t pass soon, FDA head Andrew Von Eschenbach is going to have to start informing staffers that their jobs are no longer funded.

The bill represents a victory for advocates of higher standards for making sure that drug side effects are known and promptly dealt with. Before Vioxx was yanked, some of the changes being made would be unimaginable. Until now the claims drug companies like Merck and Pfizer made about their medicines were, to a degree, negotiated. Labeling discussions between Merck and the FDA dragged on, and as a result, the agency will now be able to dictate what claims companies can make with much more force.

Another change: The FDA will be able to force drug makers to do clinical trials even after a medicine is approved and fine them if they don’t follow through. Previously, many big clinical trials regulators asked for weren’t finished. And there will be more money to study side effects of new medicines post-approval. Companies will pay more in fees when they submit drug applications, increasing the amount of money the FDA gets from industry by 25% to $400 million.

One of the farthest-reaching changes may be a new requirement demanding that the drug companies list all of their clinical trials in a registry maintained by the National Institutes of Health accessible to anyone with an Internet browser. After the studies finish, the results will also have to be posted. This will expose drug companies to new levels of scrutiny about the safety of their medicines. (See: Lynch ‘Em)

Rough-and-ready analyses of existing data set off the Vioxx controversy and the recent kerfluffle over the diabetes drug Avandia. Such analyses, where researchers try to combine different studies to get a better idea of what kinds of side effects emerge in incredibly large groups, also linked antidepressants like GlaxoSmithKline’s Paxil to suicide risk and the Johnson & Johnson heart failure medicine Natrecor to kidney problems. In both cases, there are still debates about how real the risks are, but they put a squeeze on sales.

Lots of stuff didn’t go into the bill. The Union of Concerned Scientists, while lauding the bill, worried that it didn’t do enough to deal with the financial conflicts of FDA advisers. It appears to only increase the FDA’s power to regulate direct-to-consumer ads a little bit. Pharmaceutical companies had at one point hoped that the bill would contain language that helped protect products that had been vetted by the FDA from product liability suits.

At one point, it looked as if the bill might address how the FDA should go about approving cheaper copycat versions of biotech protein drugs like insulin and human growth hormone. Right now, there’s no mechanism for approving true generics of these products, which can be extremely expensive. Part of the reason: Complex safety issues arise because proteins are far more difficult to manufacture than the simpler chemicals in pills like Vioxx and Lipitor.

But all of these issues were Johnny-come-latelies to the Congressional debate. The focus was creating a more transparent FDA with the power to better study and regulate drug safety. Legislators were probably smart, in the end, to stick with the issues they had debated the most and approve a bill that is uncontroversial now but would have seemed like a radical step three years ago.

Hopefully, the changes will strengthen the FDA, renewing the public’s shaken faith in the safety of medicines. Drug makers could wish for nothing more.

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