Jacob Rogers · August 2008
76 GEO. WASH. L. REV. 1429 (2008)
To be approved by the Food and Drug Administration (“FDA”), a prescription drug must pass a series of rigorous clinical trials. The trials test the drug’s safety and effectiveness for a specific condition and a defined subset of patients. Once approved by the FDA, however, doctors are free to prescribe that drug to treat different illnesses, different patient groups, or both. This is known as “off-label use” and it is limited only by the profession’s standards of responsibility. Far from being insignificant, off-label use accounts for over one-fifth of prescriptions in the United States, with many of these uses having little or no scientific support.
While off-label use itself is a source of controversy, perhaps more controversial is the FDA’s decision to virtually prohibit pharmaceutical companies from marketing those uses to health care professionals. Opponents of the prohibition argue that it infringes upon the companies’ First Amendment right to free speech. This Essay argues that the FDA’s regulations prohibiting pharmaceutical companies from marketing a drug’s off-label uses to healthcare professionals are, apart from being sound public policy, constitutional. The regulations pass the test for commercial speech set forth in Central Hudson Gas & Electric Corporation v. Public Service Commission and curb the industry’s incentives to operate in a manner contrary to the public interest. The Essay begins with a discussion of the relevant regulatory framework, then proceeds to an overview of the arguments for and against the policy. Part III describes the current legal status of the regulations. Finally, Part IV defends both the constitutionality and desirability of the restrictions.
