Allergan, the makers of BOTOX Cosmetic and other skin rejuvenation products, has filed a complaint in federal court in Washington against the U.S. Food and Drug Administration for violation of First Amendment rights.
A recent report in theNew York Times indicates that the Food and Drug Administration has imposed restrictions on Allergan’s ability to promote the unapproved uses of Botox for certain medical conditions. Allergan contends that they are not able to speak freely and truthfully with doctors and distributors about their drug products because of FDA requirements.
According to Jeffrey N. Gibbs, a lawyer in Washington that specializes in food and drug law, “this is the broadest attack on the constitutionality of FDA restrictions on speech brought by an individual drug company. It’s a precedent-setting case…They [Allergan] is seeking relief which would invalidate a number of the F.D.A regulations which restrict the promotion of drugs.”
Allergan is most concerned about Botox, an injectable toxin that has been formally approved by the FDA to treat deep wrinkles in the forehead. However, it is well-known that Botox also has a variety of medical uses including the treatment of excessive sweating (hyperhidrosis) and can also be used to treat muscle spasms. The lawsuit was filed shortly after the FDA required Allergan to warn all doctors and patients about the risk of complications associated with Botox which can include difficulty swallowing and breathing.
Under federal laws, drug makers such as Allergan are allowed to promote products to doctors and consumers after the product has received FDA approval, but they are not allowed to promote unapproved uses of the drug. In this situation, Allergan is not permitted to promote the fact that Botox can be used to treat more than just forehead wrinkles. In order for the company to be able to promote this fact, they would need to receive FDA approval for Botox as a drug that treats each condition.