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GAO-23-106197 1 (2023-09-08)

handle is hein.gao/gaopdd0001 and id is 1 raw text is: U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 September 8, 2023 Congressional Requesters Medical Advertising: Federal Oversight of Devices Advertising of medical devices reaches consumers directly through various media, including broadcast, print, the internet, and social media platforms. The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) and the Federal Trade Commission (FTC) have shared responsibility overseeing direct-to-consumer advertising of medical devices in the United States.1 Medical devices include a broad range of products such as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, or software intended to be used in the diagnosis or treatment of disease.2 There are millions of medical devices on the market that can be sold over-the-counter (e.g., blood pressure monitors and fertility tracking mobile applications), with a prescription (e.g., contact lenses and dental aligners), or in accordance with other regulatory restrictions (e.g., cardiac pacemakers). Since 2009, we have placed FDA's oversight of medical products, including medical devices, on GAO's high-risk list.3 You asked us to review federal oversight and the effects of direct-to-consumer advertising of medical devices. This report describes (1) FDA's and FTC's oversight responsibilities for direct- to-consumer advertising of medical devices and (2) identified effects of direct-to-consumer advertising of medical devices. To describe how FDA and FTC oversee direct-to-consumer advertising of medical devices, we reviewed documentation and interviewed agency officials to understand the agencies' oversight processes and activities related to direct-to-consumer advertising of medical devices. This includes how they coordinate with each other, and how they communicate with consumers and businesses. We also explored FDA data on adverse events and FTC data on consumer complaints to determine if they can be used to provide context for potential advertising issues related to medical devices. The FDA database is designed as part of the agency's post market surveillance effort for identifying potential safety issues. The FTC database is designed to 1The Federal Food, Drug, and Cosmetic Act in 1938 gave FDA regulatory authority over medical devices. See Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 331-397). The Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976) gave FDA new authorities, including premarket review and authority to impose restrictions on the sale, distribution or use of devices. Among other authorities, FDA is responsible for ensuring that devices introduced into interstate commerce are not misbranded, including that their labeling is not false or misleading. See e.g., 21 U.S.C. §§ 331(a) and 352(a). The FTC regulates advertising pursuant to its general statutory authority to govern unfair or deceptive acts or practices under the Federal Trade Commission Act. Specifically, section 5 of the Federal Trade Commission Act prohibits unfair or deceptive acts or practices in or affecting commerce and section 12 prohibits the false advertisement of food, drugs, devices, services, or cosmetics. See 15 U.S.C. §§ 45, 52. 2See 21 U.S.C. §321(h)(1); 15 U.S.C. § 55(d). 3See GAO, High-Risk Series: Efforts Made to Achieve Progress Need to Be Maintained and Expanded to Fully Address All Areas, GAO-23-106203 (Washington, D.C.: Apr. 20, 2023). GAO-23-106197 Direct-to-Consumer Advertising of Medical Devices Page 1

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