Allergan Sues FDA for Free Speech Violation

j0395954Allergan, 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.

Further Reading

  • A new TV show in Australia called The Shire recently spotlighted plastic surgery and featured the stars of the show having now qualms about treatments. The show’s stars Sophie and Vernesa aren’t afraid to show off their fake breasts in revealing tops and dresses, and are both sporting the infamous lip-enhanced pouts. Vernesa admits that she’s been told not to have any more filler treatments in her lips to prevent her lips from touching her nose. She undergoes Botox for the first time on camera.

  • Kim Kardashian continues to shoulder rumors about having plastic surgery, and some people report that the star has had multiple procedures including liposuction, breast augmentation, and Botox. Kim has admitted to having Botox, as well as VelaShape treatments designed to treat cellulite and smooth out the skin. She reportedly undergoes laser facial treatments to maintain her smooth skin and ward off the effects of aging. But has she really gone under the knife for more extensive procedures?

  • With only about a month of summer left, you may be considering going under the knife to maintain that bikini body or be in better shape for next season.  While demand for plastic surgery runs high during the winter months so that patients have time to heal before summer, there is still a significant demand for certain procedures over the warm weather months. According to the results of a recent report by RealSelf.com, patients are still flocking to the plastic surgeon’s office to look “red-carpet ready” or undergo a mini-makeover.

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