Doctors Beware: FDA Seeks to Regulate Your Advertising

With a few exceptions, companies that advertise their products across state lines are subject to the jurisdiction of the Federal Trade Commission (FTC) for any ad that the agency believes to be unfair, misleading, or deceptive.    FTC jurisdiction includes the advertising of over-the-counter (OTC) drugs, but does not extend to the advertising of prescription drugs and certain kinds of medical devices such as hearing aids, the lasers used in LASIK procedures, and contact lenses.  The manufacturers and sellers of those products are regulated by the U.S. Food and Drug Administration (FDA) which enforces the Federal Food, Drug and Cosmetic Act (FDCA). 

Until recently, healthcare providers who use drugs and medical devices didn’t have to worry about the FTC or FDA when running ads for their services.  Because their ads are directed solely to the residents of only one state, they fall outside the FTC’s jurisdiction, and the FDA only regulates the manufacturers of drugs and medical devices.  Or does it? 

The FDA recently sent warning letters to several ambulatory surgical centers that advertised the LAP-BAND, an FDA-cleared medical device, alleging that the healthcare providers’ promotions misled and misbranded the device.  The FDA claimed the misbranding occurred in the following circumstances: 

  • 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 they allegedly 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 may seize the medical devices. Despite its desire to extend its regulatory authority, the FDA’s legal authority supporting these actions against physicians’ advertising is unclear.  In a recent case, the FDA sought to enjoin a Florida pharmacy from compounding animal drugs that were not otherwise available through commercial manufacturers.  The federal district court hearing the case ruled against the FDA, holding that 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 appealed the decision.

What does all this mean for the thousands of doctors and surgical centers advertising lasik and lap-band procedures?

Although the FDA may or may not have the authority to do so, if it files suit against a local healthcare provider, it will have to spend a great deal of money to defend the action.  So to avoid this hit to the pocketbook, any healthcare providers who advertise their use of FDA-regulated product should be aware of the agency’s desire to regulate any claims about those products, and change their advertising practices if necessary. 



Author: Seth Heyman
Seth D. Heyman is a California attorney with extensive experience in advertising and marketing law, corporate law, contracts, governmental regulations, international business, and Internet law. He has counseled numerous successful companies, both public and private, and was responsible for regulatory compliance, contract management, corporate governance, and HR best practices for multiple organizations in many diverse industries, including marketing, telecommunications, energy, and technology development. He offers insight and guidance on federal and state direct mail, TV, radio, telemarketing, and Internet marketing laws, as well as online promotions, Internet privacy, data protection regulations, and similar matters.

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