Tuesday, March 25, 2008

Pharma, the FDA, and Legal Immunity

A helpful article on how Pharma is winning its battle in the U.S. court system to effectively destroy consumers' rights to bring suits for faulty or unsafe drugs:


One of the nasties in this piece is Daniel Troy, the pro-industry lawyer appointed by the Bushies to a high FDA post, now a powerful industry lobbyist. I have never seen a photo of Troy, but from what all of us have read about him, I imagine he wears a black cloak and has a long mustache with curly ends, like Snidely Whiplash, the stereotyped villain of melodrama in the old Rocky and Bullwinkle TV cartoon show.

Anyway, the way I try to put this in perspective--as I explained briefly in HOOKED, the industry and the FDA have a funny sort of relationship. The industry needs the FDA to be just powerful enough and not too powerful. If the FDA is too powerful, it will force the industry actually to shape up, which is bad for profits. (The industry of course does not see this as "shaping up" but rather as "meddlesome government regulation that stifles entrepreneurial creativity.") But if the FDA is too weak, then it is very clear to all parties that the industry is having its own way, which means that if something goes wrong, then the industry knows the blame will land squarely on its own doorstep. In a pinch the industry wants to be able to say, "Don't blame us, we were just doing what the FDA told us to." In the past, when the GOP small-government zealots in Congress actually seemed ready to abolish the FDA, Pharma had to rush to the agency's rescue.

The legal immunity battle reveals the ideal industry strategy. What if you could do two things at once--actually emasculate the FDA, and still persuade the outside world that the agency is an 800-pound gorilla? Then you get the best of both worlds. Blame the agency when things go wrong, but in the meantime, do whatever the hell you please.

The current Troy theory that the pro-corporation court system is eagerly lapping up is just such a two-faced strategy. The companies cannot be sued for an unsafe drug or device that kills thousands of people, because the drug or device would not be on the market in the first place if the FDA had not approved it. How could a court substitute its puny scientific expertise for the FDA with its extensive staff and advisory committees? But, in actuality, we have seen plenty of evidence that today's FDA is largely a creature of the industry, dependent on industry funds for more than half its drug approval and review budget, very easily manipulated by the drug companies--just as Troy and the Bushies want it.

The good news in all this is that there does not seem to be any basic constitutional right in play. The legal rationale the courts are using for declaring the companies immune from suits appears to relate solely to FDA regulatory law. That means that Congress has the power to amend those laws in response to court decisions that are unduly tilted pro-industry. The drug lobby will doubtless spend millions to fight off such amendments, so we will see what happens if the Congress remains under Democratic control. (On the failure of the Dems to face up to the powerful Pharma lobby so far see the previous post, http://brodyhooked.blogspot.com/2008/03/dems-equally-putty-in-phrmas-hands-more.html.)

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