Are You Sure You Want Off-Label Drug Promotion Protected Under Freedom of Speech?

On what planet is Allergan’s lawsuit, which claims the FDA’s off-label drug promotion ban violates the First Amendment right to free speech, a good idea?

Allergan asserts it is stuck between a rock and a hard place.

The FDA is requiring the company to distribute medication guides and other materials to doctors warning of the risks associated with off-label use of anti-wrinkle drug Botox (botulinum toxin type A). According to Bloomberg:

The company said it should also be allowed to proactively provide information on benefits, dosing, patient selection and other information that can help doctors make appropriate treatment decisions.

But providing that information could trigger an off-label marketing lawsuit by the Department of Justice, Allergan whines.

Really? The FDA allows companies to give doctors copies of peer-reviewed journal articles concerning the off-label use of drugs. Allergan can hand out research — vetted by unbiased experts — on the patient populations, dosing and outcomes of Botox studies in unapproved indications. What else exactly does the company feel the need to distribute?  

If it’s information genuinely necessary to ensure patient safety, it’s hard to imagine Allergan couldn’t work with the FDA and DOJ to find a solution. The fact that the company is taking the lawsuit route seems to indicate it’s looking for carte blanche to promote unapproved Botox uses (and if everybody could do that, there wouldn’t be much incentive to conduct the pricey trials to get those uses approved).

The DOJ already subpoenaed Allergan about potential off-label Botox promotion for headaches, and the company spent $7.4 million responding to the subpoena. As my colleague Jim Edwards noted, the FDA lawsuit follows conveniently on the heels of that little tussle.

A lot of drug companies will probably come up with reasons to rally behind Allergan’s cause, but would allowing off-label promotion really serve the public good? After all, pharma has not proven particularly ethical or good about policing themselves in the sales and marketing department.

And beyond that, do drug companies really want to open themselves up to the liability that could accompany being able to promote their products off-label? Because the DOJ’s $2.3 billion settlement with Pfizer over off-label Bextra promotion pales in comparison to the $4.85 billion Merck had to pay to settle its Vioxx civil litigation.

Free Speech photo by Flickr user Randy Son Of Robert, CC