US FDA Loss In Device Case Might Have Implications For Agency’s Work On Off-Label Rx Promotion
Executive Summary
While the statutes at issue in the case, which revolved around banning just one use of a medical device, do not govern drugs, experts on FDA law said the decision addressing a product’s intended use and regulation of the practice of medicine could have some impact on the agency’s Rx oversight powers.
A recent appeals court decision that limits the US Food and Drug Administration’s authority to ban medical devices for a particular use if the product is otherwise approved turned on a statute that is very device specific, but legal experts say the opinion could still have implications for the agency’s pharmaceutical work, particularly enforcement of off-label promotion restrictions.
The US Court of Appeals for the District of Columbia Circuit ruled 2-1 against FDA in the case of The Judge Rotenberg Educational Center, Inc. v. FDA, arguing that the ban of a medical device for a particular purpose regulates the practice of medicine in violation of 21 U.S.C. § 396. The Rotenberg Center challenged an agency rule banning electrical stimulation devices used to treat aggressive or self-injurious behavior. The rule allowed electrical stimulation devices to be legally marketed for other purposes.
The 6 July decision says that while 21 U.S.C. § 360f, authorized FDA to ban medical devices, it only permits FDA to ban the product in its entirety, and “speaks of no authority to place a device in an intermediate state of ‘banned in some uses.’”
FDA law experts noted that the two statutes at play are both device specific, limiting the direct impact of the case to drug makers. But they said elements of the ruling could still have ramifications for pharmaceutical regulation and FDA’s authorities, particularly in the space of off-label promotion.
“One thing that’s going on here is that the majority opinion is disagreeing with FDA’s interpretation that the statute permits FDA to distinguish between devices based on their use. And that might have some implications for how other courts approach questions around off-label promotion,” said Patti Zettler, an associate professor of law at the Ohio State University Moritz College of Law and a former associate chief counsel in FDA’s Office of the Chief Counsel.
FDA often distinguishes between different risk and benefit profiles when a product is used in different manners, Zettler said.
“Skepticism about how far FDA can go in distinguishing between different uses might have implications for off-label promotion.”
Zettler noted that the legal definition of a new drug is tied to the intended use in the labeling, making this issue a bit clearer on the drug side of things.
However, she said that given the challenges FDA has faced recently with off-label promotion, some of the court’s skepticism of the agency’s arguments and policies in this opinion “might bleed over,” to the drug world.
“There’s no direct connection [to drugs], but courts will cite a decision like this and say ‘see also Judge Rotenberg case.’ So whether it’s a direct line or an indirect line, it’s not a black and white question. This does put a thumb on the scale,” said Christopher Robertson of Boston University School of Law.
Robertson said that the DC Circuit holds a particular position of authority when it comes to federal agencies and that this decision will likely seek to remind the agency of the limits of its authority.
“The spirit of it, or the Zeitgeist of it, definitely would restrict the FDA,” he said.
Following the 2012 US Court of Appeals for the Second Circuit Caronia decision that held that the government cannot prosecute pharmaceutical manufacturers “for speech promoting the lawful, off-label use of an FDA-approved drug,” and in the Trump-era there’s been a drop in the federal government going after off-label promotion, Robertson added. (Also see "US FDA Advertising Citations Remain Rare In 2018" - Pink Sheet, 9 Jan, 2019.)
“If the Biden administration were to reinvigorate its efforts to prosecute off-label promotion, this is a warning that maybe they shouldn’t,” Robertson said.
Some worried that this decision tips the balance too far in favor of states and individual physician rights over the federal government’s ability to regulate.
“The thing that concerns me the most, is that we’ve sort of elevated the practice of medicine to this sacred untouchable thing. Maybe it shouldn’t be,” said Jonathan Darrow of Harvard Medical School.
“This opinion is yet another attack on FDA’s ability to regulate with nuance as opposed to adopting a ‘once the horse is out of the barn, we are done,’ kind of theory of regulation,” said I. Glenn Cohen, deputy dean and professor of law and Harvard Law School and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, citing the Caronia decision in particular.
Cohen believes FDA is likely to pursue a rehearing en banc with all the appellate judges as he said the three-judge panel that initially heard the case was more conservative than the entire court. But if a rehearing is denied he is less certain whether the agency would go to the Supreme Court.
“In Caronia and a few other cases FDA has been a bit gun shy about going to the Supreme Court for fear that they will cement a loss,” Cohen said. But because of the unique nature of the DC Circuit in this case, FDA may think it is worth the risk of going to the Supreme Court.
Because the statute at issue can be appealed either in the DC Circuit or in the circuit for which the person challenging reside of has their place of principal business, any similar challenger to FDA on the topic would likely go to the DC Circuit where the case is binding law, Cohen explained.
“As a result, FDA will basically treat this as binding on it across the country,” Cohen said.
Nathan Cortez of Southern Methodist University Dedman School of Law argued that this type of rigid textualist reading could backfire in terms of total products available, saying that there has long been an argument that the more you tie FDA’s hands – by weakening their post-marketing authority or limiting how they can tailor an approval – the more the agency might end up taking a more cautious approach and approving fewer products.
The dissenting judge, Sri Srinivasan, the chief judge of the DC Circuit’s Court of Appeals, also made the case that allowing the agency to fashion a less intrusive ban is also less intrusive because if FDA has an all or nothing choice it might completely ban a device, “affecting state regulation of the practice of medicine more than is necessary.”
Srinivasan argued that FDA already regulates devices differently depending at least in part on their intended use, pointing out that cranial electrotherapy stimulators are Class II devices when they treat insomnia or anxiety but Class III which, requires a more rigorous premarket approval process, when intended to treat depression.
“In light of the use-specific operation of the FDA’s regulatory authority over devices more generally it stands to reason that the agency’s banning power can be understood to functioning the same way,” he wrote.