Hospitals and physicians might reasonably assume that the Federal Food, Drug and Cosmetic Act (FDCA), administered by the U.S. Food and Drug Administration (FDA), applies to drug and medical device manufacturers and not to them. That would be reasonable, because over the century since its enactment, the FDCA has generally been applied to manufacturers and sellers rather than healthcare practitioners practicing the art and science of medicine and allied health professions. Take note, however, because the FDA appears to be taking an indirect shot at this long-standing assumption and aims to restrict certain advertising by healthcare providers.
The FDA has warned several state-licensed healthcare practitioners that the agency believes their advertising violates federal law. The FDA alleged that the physicians’ advertising of their use of a medical device was misleading, thereby misbranding the medical device under the FDCA. The FDA’s warning comes on the heels of a recent action in the Middle District of Florida, where the FDA and the U.S. Department of Justice unsuccessfully sought to enjoin Franck’s Lab, Inc. from practicing pharmacy under its state pharmacy license. See United States v. Franck’s Lab, Inc., Case No. 10-147 (M.D. Fla. September 12, 2011). In Franck’s Lab, a federal district court held that the FDA did not have the authority to regulate the practice of pharmacy, which of course is heavily regulated by state law. The government has appealed the Franck’s Lab decision to the U.S. Court of Appeals for the Eleventh Circuit.
These regulatory efforts signal the FDA’s desire to further regulate the use of medical devices and pharmaceuticals, even in areas historically overseen by state regulatory agencies. However, decisions from federal courts, including Franck’s Lab and the Supreme Court’s decision in Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002) (overturning on First Amendment grounds congressional efforts to permit FDA regulation of pharmacy companies’ advertising), call into question the FDA’s authority over state-regulated healthcare practitioners, particularly with respect to advertising activities.
FDA’s Warning Letters Regarding Healthcare Marketing Promotions
The FDA’s recent warning letters to several ambulatory surgical centers alleged that the healthcare providers’ promotions misled and misbranded a device called the LAP-BAND, an FDA-cleared medical device distributed by a medical device company.1 The FDA claimed the misbranding occurred because the physicians’ advertisements included materials such as:
- a large photo billboard reading “LOSE WEIGHT WITH THE LAP-BAND! SAFE 1 HOUR, FDA APPROVED 1-800-GET-THIN; 1-800-953-5000; PPO INSURANCE; FREE INSURNACE VERIFICATION”; and
- marketing inserts reading “Significantly Overweight? CALL: 1-800-GET-THIN,” “LET YOUR NEW LIFE BEGIN!” alongside a photograph of a woman with a caption reading “I LOST 130 POUNDS!”
The FDA objected to these advertisements because, in the opinion of FDA staff, they failed to include adequate disclosures and balancing safety information about the LAP-BAND. The FDA alleged these materials to be in violation of the FDCA even where they were followed by information such as the following:
“You may be a candidate for the LAP-BAND® if your BMI is over 40 or between 35 and 40 with other specific medical conditions. The LAP-BAND® procedure has certain risks, side effects and contraindications. Consult your physician before deciding if the LAP-BAND® is right for you. For more information visit, www.1800getthin.com/safety. Typically with the LAP-BAND®, 1-2 pounds of weight loss per week and 50-70% of excess weight lost and maintained at 5 years can be expected.”
If the recipients of these letters fail to heed the FDA’s warning, the agency will presumably seek to seize the medical devices and prevent them from being shipped in interstate commerce. The agency’s legal authority supporting these actions against physicians’ advertising, of course, is unclear.
FDA’s Recent Unsuccessful Efforts at Injunction in United States v. Franck’s Lab, Inc.
In Franck’s Lab, the FDA sought to enjoin a Florida pharmacy from compounding animal drugs that were not otherwise available through commercial manufacturers. The FDA advanced the expansive bright-line position that any bulk compounding of animal medications violated the FDCA. The FDA argued this position despite the fact that compounding is historically an essential skill within the practice of pharmacy and is commonly performed by pharmacists nationwide. The federal district court hearing the case found the FDA’s argument untenable, for it meant, in effect, that “state-licensed veterinarians and pharmacists have, with the FDA’s blessing, been ‘living in sin’ (according to the FDA) for over twenty years.” Calling the FDA’s position “maximalist,” the court held the FDCA did not provide the FDA authority to enjoin the “long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non food-producing animal by compounding bulk substances.”
The government has taken an appeal of the court’s order in Franck’s Lab and the parties are briefing the issue now. The recent warning letters to physicians suggest FDA regulators were apparently unbowed by the Franck’s Lab opinion.
Practical Advice for Healthcare Practitioners
Although on its face, and by historic application, the FDCA primarily regulates manufacturers, packagers and distributors of the drugs and medical devices used by healthcare providers, it is important for healthcare practitioners to understand the FDA’s intentions. These recent enforcement actions indicate the agency continues to seek to expand its authority over the practice of medicine and pharmacy. While the FDA’s statutory authority for such regulation is debatable, healthcare
providers who find themselves in the FDA’s crosshairs may face considerable expense defending themselves. Healthcare providers, particularly those who advertise by extolling the availability and use of FDA-regulated products, should be aware of the FDA’s views regarding the permissibility of claims about those products and conform their advertising accordingly, to the extent practical.