Allergan sues FDA (NYSE:AGN)
One of the well known makers of the Botox wrinkle treatment, Allergan Inc, has gathered its courage and challenged the government’s ban on off-label drug marketing to doctors. The company challenges this idea by the FDA saying that it violates the company’s right to freedom of speech. The company has clearly stated in its lawsuit that it they should be able to educate the doctors about the risk and benefits of the drugs when using for unapproved treatments.
The Food and Drug Administration panel has approved Botox for various uses apart from using it as a wrinkle treatment. The FDA has also approved it for the use of eye muscle disorders and excessive underarm sweating. However, it was brought into light that physicians often use it for unapproved conditions like muscle-spasm condition. Hence, the off-label drug marketing policy by the FDA is incorrect in this context.
The lawsuit by Allergan stated that while drugs are being legally prescribed by the physicians for unapproved uses, companies are forbidden from marketing drugs, especially to physicians, for any use not approved by the FDA. So far the FDA has not commented on the pending litigation and the currently the lawsuit is filed in the U.S. District Court for the District of Columbia against the government and the FDA.
The news has definitely hurt the share prices of Allergan, but the company has remained firm on its decision and has said that this was a matter of necessity. It was in September this year when FDA instructed Allergan to implement REMS program which discusses some off-label prescribing guidelines for doctors. However, the company is not happy with the REMS program and has boldly said that this program does not serve public health. However, analysts are concerned over the penalties that government might levy on Allergan during the trial.
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