Two researchers are calling for the US Food and Drug Administration (FDA) to take a stand against off-label promotion in light of recent legal proceedings, and urge the courts to reject the precedent set in United States v. Caronia.
The call comes during a time of uncertainty for the future of off-label promotion and just one week before FDA's upcoming two-day public hearing on off-label communications.
In Caronia, the Second Circuit Court of Appeals reversed the conviction of Alfred Caronia, a former Orphan Medical sales representative, for conspiring to promote the drug Xyrem (sodium oxybate) for unapproved uses. According to the ruling, Caronia's statements promoting the drug were protected under the First Amendment as commercial speech.
The case is seen as opening to door for later challenges against restrictions on off-label promotion, including Amarin Pharma, Inc. v. FDA and Pacira Pharmaceuticals, Inc. v. FDA.
For its part, industry has welcomed looser regulation of off-label promotion. In July, the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) issued a set of principles that seek to promote the sharing of "truthful and non-misleading" information.
Argument Against Caronia
In an article published in the New England Journal of Medicine on Wednesday, University of Arizona Law Professor Christopher Robertson and Harvard Associate Professor of Medicine Aaron Kesselheim, argue that the court's decision in Caronia "subverted decades of presumptions about how the government could oversee the behavior of the pharmaceutical and medical device industries."
However, the authors say that the precedent set under Caronia is set to face its "first real test," in an upcoming appeal in the case of United States v. Facteau et al. In July, a jury convicted ex-Accelarent CEO William Facteau and Vice President of Sales Patrick Fabian of 10 misdemeanors related to marketing a device for unapproved uses. The device in question, the Relieva Stratus Microflow Spacer was cleared by FDA to maintain an opening to a patient's sinus; however, prosecutors argued that the company had marketed it as a drug delivery device.
"We believe the First Circuit and other courts need to reject Caronia on its merits," the authors write.
Instead, the authors argue that speech can be justifiably used to demonstrate intent, giving the following example:
"It may be perfectly legal to buy a gun or drive across state lines, but if a defendant's own speech reveals he or she did so as part of a conspiracy to sell cocaine or a murder-for-hire plot, that speech is routinely used to prove the illegal intent."
The authors go on to argue that this precedent will lead to a situation where courts are left to determine the truthfulness of companies' promotional claims.
"Congress established the FDA's premarketing approval process to channel claims about safety and efficacy into an expert agency, where the claims can be evaluated rigorously and independently on the basis of submitted evidence," the authors write.