7 February 2017 - Since 1962, the US 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.