So no one died from fake heparin on the FDA’s watch? Or suffered AEs from Vioxx? The price of regulation is public complacency and death.

You seem to think it’s out of the question to close down the FDA. That, of course, is one of the problems. If an agency did a good job in 1978, that is not a reason to assume that it works or can work in 2008.

For example, until recently, people wanting a range of opinions (good and bad) about a drug had to rely on word of mouth or official government sources. Now you can check out the sidebar of this blog alone, to get a range of opinion (to say nothing of Facebook patient groups of people actually using the drugs). And a big chunk of people don’t trust any information the government puts out, especially when the president is from the other party. Memo to Bush haters: the FDA isn’t suddenly going to become more competent at spotting fake ingredients because President Obama is in the White House, unless the FDA’s staffers have been deliberately punishing America for Florida 2000.

Tort lawyers are (much of the time) a diabolical nuisance: they create litigation insurance and compliance costs, which are a significant part of the reason prices go up. But are they better motivated to hunt down and punish negligent drugmakers, than the FDA is? You better believe it! One third of the settlement amounts is a powerful motivator. And the payouts hit share prices therefore bonuses. An FDA DTC non-compliance fine two years late? Ha!

On pharmacoviligance, if not the original licensing of a drug, the FDA is not good enough, and I argue, can never be good enough. DTC monitoring is another joke: it would be better if the US public was told: these ads may be full of lies, we don’t know so take them with a pinch of salt. And scrap DTC monitoring.

Look at it another way: if you had to pick only one function of the FDA that it does effectively and could not be done better by Public Citizen, ambulance chasing lawyers and blogger, which would it be? The FDA should focus on the thing it has to do, and not pretend to provide perfect safety all the time for everyone. Unicorns don’t exist.

Some talk about the “price of regulation” and never imagine the price of deregulation - and I’m talking about dollars in this instance, not lives.

I can’t see a solution that doesn’t involve shutting down the FDA and letting drugmakers face the music when they get it wrong. So either pre-emption and the FDA does its job (if that’s possible, which I doubt), or no pre-emption and close down the FDA’s quality oversight role.

As I recall, the issue of a generic company’s responsibilities also came up in Colacicco. At least one court ruled pretty definitively that a generic company cannot be held liable for not making changes brand company didn’t.