Allergan Inc., the makers of Botox, and it's sister product, Botox Cosmetic, are bringing a lawsuit against the United States, the FDA and it's commissioner, Margaret Hamburg, as well as the Kathleen Sebelius, secretary of Health & Human Services. The suit alleges that the country's current stance concerning off-label use of drugs is unconstitutional.
A doctor can legally prescribe a medicine to treat an illness even if that medicine is not approved for that purpose. This is a so-called off-label use. While this practice is legal, drug companies are not allowed to "push" off-label uses to doctors.
Drug companies, obviously find this unfair. They argue, that if a drug works to treat an illness they should be able to promote it even before they have proceeded through the countless clinical trials needed in order to gain approval from the FDA. The basis of their argument - Free speech!
Allergan's complaint claims the FDA "has promulgated a series of overlapping and interlocking regulations that combine to render unlawful virtually all manufacturer communication, through any avenue, to any audience, about the lawful off-label use of a prescription drug." Furthermore, "the inability to share such important information proactively with the medical community violates the First Amendment and potentially diminishes the quality of patient care."
I think the First Amendment argument is a novel approach. The Courts, however, have often limited free speech if necessary for the greater good. One could argue that the FDA is already hopeless in combatting the power of drug companies, and this lawsuit is an attempt to cripple the FDA which serves an important and valid purpose for the general public.
A victory for Allergan clearly creates a slippery slope for drug manufacturers who will be able to enter a product into the market for one purpose and then promote it for countless others without the safeguards created by the FDA.
That's right - 2.3 BIllion.
The settlement brings an end to numerous civil and criminal filings against Pfizer and subsidiary, Upjohn, regarding the painkiller Bextra which was pulled from the market in 2005, as well as a few other drugs. As part of the settlement, the corporation will plead guilty to misbranding Bextra with the intent to defraud.
The Dept. of Justice initially brought the charges alleging that Pfizer promoted Bextra for off-label uses that were not approved by the FDA. The Department also alleged that Pfizer gave kickbacks to doctors to encourage them to prescribe Bextra (a charge that Pfizer still denies).
I'd like to believe such settlements will cause drug companies to re-think the way they rush drugs to the market and promote them to the public, but alas, much like the tobacco companies, such settlements are a small drop in the ocean. I wouldn't be surprised if Pfizer still made a profit on Bextra despite the settlement.
That is the question that a Boston Federal Court will decide as trial is set to begin. Superstar plaintiff attorney Mark Lanier is bringing the suit alleging that the Pfizer anti-epilepsy drug increases a patient's risk of suicide. This case, the first of some 1200 prepared to go to suit in the coming years is predicted to mirror the Vioxx lawsuits.
Attorney Lanier has admitted that he is starting with a tough case to test the waters. He represents the family of Susan Bulger, a thirty-nine year old woman who took the drug before hanging herself in 2004. The case is made difficult by the fact that Ms. Bulger attempted suicide no less than three times previously.
A win for the plaintiffs in this early case would be devestating to Pfizer with over a thousand lawsuits pending.