I wish that statement didn't have to be qualified. I wish some drug company would have the cojones to flat out state, once and for all, that the muzzle the FDA puts on every pharmaceutical company that does business in America, is unconstitutional and a violation of rights.
The rep's argument, though, is that he should have been allowed to speak about this particular off-label use because the manufacturer had already submitted data to the FDA for approval of that use. FDA's rationale for violating manufacturers' rights is to say that, if it allowed off-label promotion, manufacturers would have no incentive to conduct clinical trials to provide evidence to support new uses of their drugs. The Jazz rep and his lawyer say that, since the trials were already conducted, there was no need to incentivize Jazz to perform more trials, and therefore the rep's off-label speech wasn't so wrong.
FDA's counterargument is that it's not the speech that's wrong, but rather "the crime is introducing the drug into commerce." I suppose it's easier to convince Americans that governmental activity falls under the commerce clause than it is to convince them that they should sacrifice their First Amendment rights, hence the attempt to call the rep's action something other than what it is, an exercise of freedom of speech.
Where do I begin to point out all the things that are wrong here?
- Why yes, FDA, you have criminalized free speech for years. As I said, I wish pharmaceutical companies had the will to stand up and say so, because from the FDA's eagerness to characterize this "crime" as one of commerce rather than speech, it's clear the enemy is a bunch of mean little men who scurry like rats when presented with the truth.
- Who says pharmaceutical companies wouldn't have incentives to do clinical trials without the FDA? They certainly wouldn't need to deal with the kind of bureaucracy the FDA imposes, but that doesn't mean pharma companies wouldn't want to do trials -- precisely because lots and lots of people won't take drugs without that level of evidence that they work. In order to increase market share, then, companies have to do trials, or find some other way of showing that their products work.
- Pharmaceutical companies aren't the only ones doing trials. In a free market, anyone who wants to answer a particular question about whether a drug works, is free to do so, provided he can recruit enough patients for a trial and doctors to conduct it. Even in our not-at-all-free market, plenty of nonprofit groups and individual hospitals or doctors do this. People want information. That means, in a free market, it's often profitable to be the discoverer of such information. You don't have to muzzle pharma companies to incentivize the release of data.
In any case, I highly doubt that the Jazz rep is going to win his case -- even though it's true, the FDA is violating his and his employer's rights.
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