Justinian Lane

FDA ill-equipped to handle off-label marketing

Also from the following article: The FDA has 44 employees responsible for reviewing almost 70,000 ads per year.  

WASHINGTON - When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot.

When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically takes four more months for the company to fix the problem. During that time, a lot of prescriptions can be written.  [And many millions of taxpayer dollars can be spent on those prescriptions. - JCL]

Source: Off-label Rx draws Senate scrutiny | Philadelphia Daily News | 07/28/2008

Justinian Lane: Author Bio | Other Posts
Posted at 1:43 PM, Jul 28, 2008 in Civil Justice | FDA
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The restriction on off label discussion violates the First Amendment. More than half of all prescriptions are off label. It precludes drug companies from testing and discussing half of medicine.

Posted by: Supremacy Claus | July 28, 2008 7:59 PM

One thing that we all learn in the practice of medicine is that some medications have more than one use. This is especially true in migraine medications as so many other medications can be used to help prevent the disabling headaches. Are these medications approved for this? No. Do they work yes. Why cant the company announce this? Lets look at aspirin. It was approved for headaches and pain management. But wait, we soon learned that it helped with rheumatologic diseases and help prevent and decrease damage from heart attacks.

What is the rational basis for not letting companies present other uses of their products. One thing that we see all the time is when a medication is approved and used in Europe and can be life saving but since it is not approved for that indication in the states, mums the word.

Posted by: throckmorton | July 29, 2008 8:43 AM

This also happens to be the season to propose budgets for next year. I think the need for inspectors to monitor off label promotions in casual conversations, in advertisements is for around an additional 10,000 federal workers.

Posted by: Supremacy Claus | July 29, 2008 11:55 AM

It's worth noting that hundreds of thousands of people died unnecessarily because of the FDA's off-label prohibition preventing aspirin companies from advertising that aspirin helped prevent heart attacks -- more than from any Type I error committed by the FDA.

The Daily News statistic given is meaningless -- cars make millions of stops at thousands of red lights every day in the DC area, yet there are only a few hundred police officers (if that many) tasked with ticketing people who run red lights. That doesn't mean that red lights aren't effective or that the police are underfunded in stopping red-light runners. As I noted in my Spectator article (which Lane claims he read), the criminal penalties for violating off-label prohibitions are so severe that no reputable pharmaceutical manager knowingly risks it.

Posted by: Ted | July 30, 2008 10:37 AM

"... the criminal penalties for violating off-label prohibitions are so severe that no reputable pharmaceutical manager knowingly risks it."

Nice hedging, Ted. Now if I list the variety of pharmaceuticals who engaged in off-label marketing, you'll just claim that it was either unknowing, or the work of a rogue, unreputable manager.

You've still not explained whether you think pharmaceuticals should be liable for failure to warn claims for off-label marketing.

Got a link to any study that supports your "hundreds of thousands of deaths" statistic?

Posted by: Justinian Lane | July 30, 2008 10:51 AM

Let me correct my error: the figure from Dr. Pepine (repeated by Tabarrok and Klein) is tens of thousands, not hundreds of thousands.

Posted by: Ted | July 30, 2008 9:34 PM

Ted is absolutely correct. Off label use of approved medication represents the greatest untapped mine of medical advancement, at minimal cost, with little effort, but massive payoff. The lawyer has deterred this mining by oppressive regulations, by suing people for off label use, and by trying to making such use into some kind of corruption, as in your irresponsible posting.

We could all be far healthier at low cost of generics if we could restrain the cult criminal. I would support, morally and intellectually, the formation of patient groups that bring direct action in self-help to the enemies of clinical care, the regulators, the pro-litigation biased judges, the low class plaintiffs, and both plaintiff and defense bars.

Posted by: Supremacy Claus | August 2, 2008 11:45 AM