The FDA’s purpose is to protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices and our nation’s food supply, cosmetics and products that emit radiation. It is also responsible for helping speed innovations that make medicines more effective, safer and more affordable. Additionally, the FDA is also responsible for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use in minors.

There has, however, been a spate of recent cases that make one question whether the FDA has gone from being an organization that protects the interests of consumers to an aggressive organization that is exceeding its own constitutionally-allowed authority. Is the FDA actually exceeding its authority?

Off-Label Advertising

A series of court decisions from the Supreme Court (IMS v. Sorrell) to circuit and district courts (Coronia, Amarin) has informed the FDA that it has exceeded its constitutionally-granted authority in preventing the off-label promotion of drugs. The FDA has finally decided to take a step back and reassess its own position on off-label promotion. Nevertheless until the FDA makes specific changes, companies must exist in the regulatory equivalent of Schrodinger’s cat – act as if rules exist, despite the lack of them.

Surgical Centers

The FDA sent out warning letters to a number of surgical centers for advertising practices. The practice of medicine, like the practice of pharmacy, has traditionally been regulated by the state – not by federal authorities like the FDA. Nevertheless, eight California surgical centers and a marketing firm called 1-800-Get-Thin LLC sent out a promotional piece for a lap band and advertised it for weight loss. The FDA warned that the billboards and advertising inserts for the product failed to provide adequate risks, precautions, side effects and contraindications.

Healthcare providers have traditionally been allowed to prescribe off-label; however, the FDA has declared that by marketing the product, they were exceeding this authority. The FDA was concerned about the advertisements by the surgical centers that focused on a specific product, and hence decided to hold these centers to the same standards as they would a pharmaceutical or device manufacturer who is not allowed to market off-label.

In the case of these surgical centers, the FDA at a recent event suggested that simply talking about a single device automatically put the issue under the FDA’s jurisdiction. If it comes to court, there is a question whether the FDA had the authority to send this warning letter. But until it’s challenged, that warning letter would stand.


As seen by the constitutional limits imposed by Courts on the FDA, it is likely that a court might tell the FDA that it is demonstrating a pattern of limiting speech and/or action outside its own jurisdiction. For more information on this issue, contact the Kulkarni Law Firm.