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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Is this the beginning of the end of the off-label marketing ban?

Posted in FDA Regulation, Off Label Marketing

If Allergan is successful in challenging this rule, then FDA approval will become meaningless.  Pharmaceuticals will push drugs for any and every ailment under the sun, regardless of whether the drug has been shown to have safety or efficacy for that use.  Some would say that’s the world we already live in…

Oct. 2 (Bloomberg) — Allergan Inc. is challenging a U.S. government rule that prohibits marketing its wrinkle-smoother Botox for unregulated uses, saying the policy restricts information that is needed for patients’ safety.

Doctors should get dosing guidelines and details of injection techniques to reduce risks when giving patients Botox for uses that haven’t been approved, Allergan said today. The drugmaker announced yesterday that it would file a court order enabling the distribution of such information. This is the first lawsuit challenging this aspect of the FDA’s marketing rules, according to the company.

Source: Allergan Sues FDA to Market Off-Label Botox Uses (Update2) – Bloomberg.com