FDA Bill -- the Good, the Bad and the Ugly

The House passed Food and Drug Administration reform legislation yesterday; the Senate will do so today and send it to President Bush, where a quick signing is assured. Here's what I like in the bill:

* It requires registration of all clinical trials, and the public posting of the results of those clinical trials a year or so down the road (could go as high as 18 months later, if I read it properly). If the FDA writes good regs, and the National Institutes of Health constructs a good website, this will be a tremendous boon to researchers seeking safety clues in the data contained in scattered clinical trials, some of which is currently kept hidden from the public by the companies that sponsored the trials. Dr. Steven Nissen of the Cleveland Clinic, who played a central role in uncovering the dangers associated with Vioxx and Avandia, deserves much of the credit for ensuring this part of the legislation survived intact despite intense drug industry lobbying to remove it from the bill.

* The bill limits the practice of granting conflict-of-interest waivers to scientists and physicians who sit on the FDA's advisory committees, and will slightly reduce their number over the next five years. This is nowhere near the ban that consumer groups pushed for, but it's a start.

* There will be better post-marketing surveillance of drugs by both companies and the FDA, and the office of drug safety will get more money and people to do its job.

Here's what I don't like in the bill:

* The pharmaceutical industry removed a provision that would have taken three months off the additional patent exclusivity granted companies that conduct clinical trials on kids for their blockbuster drugs. For a $1 billion-a-year drug, this is like giving away $250 million in additional sales in exchange for running a trial that may cost $10 million. Even if you figure in the tens of millions of dollars that the drug industry poured into lobbying Congress this year, this one provision alone more than pays their lobbyists' fees.

* The bill does nothing to curb direct-to-consumer advertising, although it does give the FDA a bit more authority to pre-review the ads.

* The bill does almost nothing to subject medical devices like stents to the same scientific rigor that applies to drugs. This is clearly a missed opportunity, and a fit subject for ongoing hearings on Capitol Hill.

* The bill's bottom line is that the FDA will continue to depend on industry user fees for another five years. This is a structural conflict-of-interest that needs to end. You don't want the cop's salary to depend directly on the people who get the tickets.

And the ugly?

The drug industry tried to slip a provision into the bill that would eliminate consumers' right to sue in state courts when they are harmed by unsafe drugs that slip through the FDA safety net. Most product liability suits hinge on what lawyers call the duty to warn. The industry wanted a provision that said that: a) if the FDA failed to tell a company to put a warning on a drug's label; and b) the drug later turned out to be unsafe; and c) the safety concern had been known to the company and it had been communicated in some fashion to the FDA; then the company had met its obligation to warn consumers (by not warning them) and the lack of federal action preempted all state product liability laws.

Sound fair to you? Apply the above proposal to Merck, which spent years dickering with the FDA over the content of the warning label for Vioxx, and you get a picture of what was at stake. Consumers Union and the trial lawyers launched a last-minute lobbying blitz to keep the preemption language out of the bill, and they succeeded.

Posted by gooznews at September 20, 2007 08:05 AM