Lawsuit Challenges FDA Authority To Regulate Off-Label Promotion

From The Cancer Letter, Jan. 15, 2010:

FDA’s authority to regulate what companies can say about off-label uses of drugs is once again being tested in federal courts.

Allergan Inc., the sponsor of the neurotoxin Botox, has filed a suit that broadly challenges the regulatory agency’s powers in the context of the First Amendment.

Though the issue of off-label promotion is important throughout medicine, it is particularly relevant to oncology, where such use of drugs is widespread. Allergan’s court challenge, filed in the U.S. District Court for the District of Columbia, is taken seriously by legal observers and FDA-watchers familiar with what can happen when the courts apply the constitutional filter to the agency’s regulatory practices.

Also in this issue:

• Harold Varmus plans to leave job as MSKCC president.
  

For the rest of the story, click on The Cancer Letter Archive at left to read the Jan. 15 issue (subscription or day pass required).

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tags: FDA|  drug development