News & Events

FDA In Brief: FDA takes new steps to help ensure clear presentation of health information in prescription drug promotion

For Immediate Release: Dec. 11, 2017

Media Inquiries

  Stephanie Caccomo
  301-348-1956

"Promotional material that drug makers share with patients and providers can be a helpful tool for encouraging patients to seek medical care and raising awareness about new and different treatment options. The FDA plays an important role in helping to make sure these presentations are truthful, balanced, and nonmisleading, and we need to study promotional material to constantly improve our oversight over these activities,” said FDA Commissioner Scott Gottlieb, M.D. “A key to our oversight is recognizing claims in prescription drug promotion that have the potential to deceive or mislead consumers and health care professionals. We also need to have clear rules for how sponsors can present certain information, even elements as straightforward as the product name, and do so without introducing features that could mislead patients. These new efforts are part of an ongoing policymaking process aimed at making sure our practices protect consumers and help ensure that the information provided to them is useful for protecting their health."

Today, the FDA issued two Federal Register notices related to prescription drug promotion from the FDA Center for Drug Evaluation and Research’s Office of Prescription Drug Promotion. The first Federal Register notice announces the FDA’s final guidance on product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. The disclosure of the product name in promotional materials is important for the proper identification of the products to ensure their safe and effective use. The second Federal Register notice is related to an FDA proposal to study the ability of consumers and healthcare professionals to spot and report deceptive prescription drug promotion practices. The ability to spot deceptive prescription drug promotion in the marketplace has important public health implications. Patients may use information from drug promotions, such as information about a product’s efficacy and risks, when exploring treatment options and making treatment choices. Likewise, health care professionals may consider information from promotional materials when making prescribing decisions. In cases where such information is false or misleading, consumers may ask for and health care professionals may prescribe specific drugs that they would not otherwise request or prescribe, respectively. Once completed, the proposed studies will provide data on whether consumers and health care professionals can identify claims as false or misleading, and whether they would be willing to report deceptive drug promotion to the FDA. Although both studies will assess consumers and health care professionals, one study will focus on the degree of deception in an ad while the second study will focus on implied versus explicitly deceptive claims.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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