Allergan suing FDA over off-label policy
The San Francisco Chronicle reports that Allergan Inc., the maker of the Botox wrinkle treatment, challenged the government’s ban on off-label drug marketing to doctors, saying it violates the company’s right to freedom of speech. The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses.
Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions. While physicians can legally prescribe a drug for unapproved uses, companies are forbidden from marketing the product, especially to physicians, for any use not sanctioned by the FDA. Part of the logic behind the FDA rule is this: the agency has reviewed detailed clinical trial data, spanning years, before approving a drug’s use for a specific purpose. That same level of scientific, controlled review has not gone into unapproved uses.
In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.
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