Washington Legal Foundation Examines Off-label Promotion
A Washington Legal Foundation legal backgrounder examines the recent convictions of two Acclarent (Johnson & Johnson subsidiary) executives in U.S. v. Facteau (see story) and the questionable boundaries that currently separate speech from criminal conduct. Authored by Sedgwick attorneys Anthony J. Anscombe and Mary Beth Buckley, the backgrounder notes how the convictions “underscore how speech rights, due process, and public health could be better protected through reform of FDA’s regulatory scheme. Such reform should favor more speech, not less.”
In July, former Acclarent chief executive officer William Facteau and vice president of sales Patrick Fabian were acquitted by a Boston jury of felony charges that they illegally marketed a medical device for off-label uses. While cleared of the felony charges, the jury did find the two guilty of less serious misdemeanor charges of introducing adulterated or misbranded medical devices into interstate commerce. Acclarent also agreed to pay $18 million to settle a federal whistleblower false claims lawsuit alleging that the company marketed a sinus device for a drug delivery use not approved by FDA, and causing healthcare providers to submit false claims to Medicare and other healthcare programs (see story).
“The Facteau convictions send a harrowing message to drug and device company executives that they can be criminally punished for conduct that was not, in itself, illegal, and that only became illegal based on truthful, non-deceptive expression,” the backgrounder contends. “The unimpeded flow of truthful speech helps patients. The Supreme Court has urged time and again that more speech, not less, is the appropriate remedy when truthful speech has a potentially negative societal impact. FDA fears that off-label promotion will cause physicians to prescribe medications for uses that have not been established by rigorous science, and that industry will no longer have financial incentives to conduct that rigorous science. The Caronia and Amarin courts, however, pointed out that FDA has numerous tools at its disposal to ensure that medical professionals receive full disclosure of off-label risks. For example, FDA could mandate affirmative statements that it has not reviewed off-label uses and that doctors should proceed with caution.”
The authors recommend that FDA align its regulations and enforcement priorities to focus on preventing promotional speech that misleads physicians, which would still give industry substantial financial incentives to seek approval for new product uses. “Doctors mediate treatment options, and they are both scientifically sophisticated and concerned about their own potential liability,” they write. “For these reasons, firms which invest in scientific research in support of new uses that win FDA approval should still enjoy a competitive advantage in the market for medical products.”