Since 1962, the US Food and Drug Administration (FDA) has required companies to establish, with adequate and well-controlled clinical trials, a drug’s safety and efficacy for each intended use and has prohibited the “off-label” promotion of drugs. For companies to market an approved medicine for new indications, they must first conduct trials and submit data to establish safety and efficacy, as was the case for the initial approval.
The FDA’s approach to off-label promotion is in jeopardy, however. In response to recent US Supreme Court decisions strengthening First Amendment protection for companies, the pharmaceutical industry has framed off-label marketing as a free speech right. Drug companies have won several important court cases that have weakened the FDA’s authority to regulate off-label marketing. Although the legal issue—whether the FDA’s restrictions on off-label marketing are unconstitutional—remains unresolved, the agency has initiated a comprehensive review of its approach to off-label marketing. On November 9 and 10, 2016, the FDA will convene a public hearing to address “its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products.”1
Kim J, Kapczynski A. Promotion of Drugs for Off-label UsesThe US Food and Drug Administration at a Crossroads. JAMA Intern Med. 2017;177(2):157-158. doi:10.1001/jamainternmed.2016.7151