Under our regulatory system, a manufacturer of a new drug cannot market or promote the product for any use not approved by the Food and Drug Administration. Because a drug may be safe and effective for one use, but unsafe or ineffective for another, the regulations are a crucial part of the federal scheme for protecting patients from unsafe and ineffective drugs.
In the fall of 2009, Allergan, Inc., the maker of Botox, sued the Food and Drug Administration, seeking to prevent the FDA from enforcing regulations that restrict drug manufacturers promotion of unapproved uses of drugs. Allergan claims that the restrictions violate the company's first amendment right to free speech. Public Citizen filed an amicus brief in support of the FDA, explaining that the restrictions challenged by Allergan are crucial for protecting patient health. In September, 2010, Allergan and the FDA announced that Allergan had agreed to dismiss the case as part of a settlement of several cases involving the company and the government.