FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion

In what's been described as a "surprise move" (here) the FDA recently published a notice that it will hold a 2-day public hearing this November to obtain "input on issues" related to off-label product communications about by pharmaceutical and medical device companies. FDA defines off label use of drugs as, "Use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling."

FDA's authority to prevent or even regulate off-label promotion by pharmaceutical companies is dwindling. After losing to Amarin in court ("FDA Deal with Amarin: Does It Mean More or Less Off-Label Promotion?"), FDA suffered another setback when it settled a case with Pacira Pharmaceuticals (here).

In both cases, the plaintiffs argued that off-label marketing was protected free speech as long as the information was truthful and not misleading. While the FDA still insists it has the ultimate authority to decide what is and is not truthful, other entities - most notably the Washington Legal Foundation (WLF) - have claimed a stake in the debate.

FDA issued some "draft guidance" in February, 2014, but this did not mollify WLF, which claimed that the guidance document is in "direct violation of a 1998 permanent injunction (WLF v. Friedman) it obtained against the agency to prevent it from trampling on industry's purported First Amendment rights." WLF said it "intends to enforce its injunction and will seek contempt of court citations against FDA officials who violate its terms" (read "WLF to FDA Regarding Distribution of Off-Label Reprints: See You in Court!").

The FDA cannot win the "First Amendment" battle and has hinted in the public hearing notice that it may have to allow pharma companies to engage in off-label communications directly to "patients and consumer audiences" and not just to physicians.

If you stay awake reading the Federal Register Notice (here) and get to the questions for which the FDA is seeking input, you'll find this unusual set of questions:

Read more »