In an attack on the regulation of drug marketing, Allergan, the makers of the antiwrinkle shot Botox, as well as popular Ophthalmic drugs Restasis and Lumigan, have filed a free-speech lawsuit against the federal government. In the Complaint, filed in federal court in Washington, Allergan charged that restrictions on promoting unapproved uses of Botox for medical conditions like spasticity violate the company’s First Amendment rights to speak freely and truthfully with doctors about its drug products. Allergan is suing the Food and Drug Administration (FDA), which is responsible for regulating drug promotion, and the Justice Department, which has prosecuted companies for unlawful drug promotion.
The Food and Drug Administration approves medicines for specific therapeutic indications. Once a drug is approved for a specific use, doctors are then free to use their medical judgment to prescribe the drugs for other nonapproved, or off-label, uses. Manufacturers, however, are prohibited from promoting off-label uses to medical providers or advertising such uses directly to the public.
Companies that violate off-label marketing rules face prosecution and fines. Last month, for example, Pfizer agreed to pay fines of $2.3 billion to settle charges that the company had illegally promoted several drugs, including the painkiller Bextra, which has been withdrawn.
Allergan is seeking in its lawsuit invalidate federal regulations which prohibit drug manufacturers from promoting their drugs for off-label uses to medical providers or advertising such uses directly to the public. The lawsuit filed by Allergan comes in the wake of a Department of Justice probe of Allergan’s alleged off-label marketing of Botox, which has reportedly already cost the company $7.4 million.
Although Allergan denies that there is any connection between its suit against the FDA and the Justice Department investigation, the timing is certainly curious. Allergan’s broad assault on the FDA’s core authority, especially given the ongoing Justice Department probe, raises the serious question of whether there is far greater, yet undisclosed, off-label promotion of drugs going on at Allergan.
For more information on the Allergan lawsuit: http://www.nytimes.com/2009/10/03/business/media/03drug.html