As the U.S. government cracks down on advertising off-label uses of drugs, one company is fighting back. Allergan, Inc., which makes the drug Botox, has filed a legal action against the government, seeking the right to “share truthful, relevant information” with physicians about off-label therapeutic uses of its drugs.
Off-label use of approved drugs by doctors is not illegal. But a drug company isn’t supposed to push off-label uses. In its complaint, the Irvine, California, drug company contends that the government’s legal position — that it’s a crime for a drug company to communicate truthful information to physicians about off-label uses of its products — violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act.
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