Medical Device Direct-to-Consumer Advertising—Will FDA Tighten the Reins?
Following the financial success of direct-to-consumer (DTC) advertisements for pharmaceutical companies, medical device manufacturers have increased their own advertising of device products directly to patients through the Internet, radio, television, and print media over the past few years. DTC advertisements for medical devices, such as blood glucose monitors and hip replacements, have enhanced patients’ awareness of their own medical conditions—thereby causing them to seek necessary treatments, ask informed questions and comply with recommended therapies.
James R. Ravitz, Amy Swift Arent Fox PLLC |
Pursuant to the Federal Food, Drug and Cosmetic Act (FD&C Act), the FDA is authorized to regulate the labeling and advertising of “restricted” medical devices, or those device products that require a prescription. While the FDA has not currently adopted regulations that establish specific requirements for the content or format of medical device advertisements, in general, advertisements for restricted devices must include a “brief statement” of the device’s intended uses, warnings, precautions, side effects and contraindications (21 U.S.C. § 352[r]). In addition, a restricted device advertisement must not be false or misleading (21 US.C. § 352[q]).
In 2004, the FDA further clarified DTC advertisements for restricted devices and issued a draft guidance that recommends methods for companies to follow when stating safety information in DTC broadcast advertisements. These suggestions include displaying an easy-to-understand, written statement of a device’s (1) intended use, warnings, precautions, side effects and contraindications and (2) most serious and common risks.
DTC broadcast advertisements should also provide information on how consumers may obtain package labeling from other outlets. These additional resources include (1) a toll-free telephone number that, upon calling, provides consumers with the choice to have the label mailed to them or have the label read to them over the phone using recorded labeling topics; (2) a reference in the broadcast advertisement to a print advertisement that runs at the same time in publications that reach the same exposed audience; (3) a Web address; or (4) a statement that practitioners may provide additional device information to consumers.
Although the FDA has not adopted specific regulations concerning DTC advertisements for restricted devices, recent events suggest that both the agency and federal legislators could execute a more stringent policy for DTC advertisements for all medical products, including restricted devices.
For example, in 2004, the FDA conducted a study on patient and physician attitudes and behaviors associated with DTC promotions of prescription drugs. While this research indicated that DTC advertising has positive effects, such as increasing patient awareness of medical conditions, it also revealed that some doctors feel pressure to prescribe the advertised products and both patients and doctors believe DTC advertisements overstate drug efficacy and do not present a fair balance of benefit and risk information.
In addition, on September 8, 2005, Representative Sherrod Brown (D-OH) introduced the Medical Advertising Reform Act (H.R. 3696), which would require FDA review and approval prior to a company’s advertising a drug or medical device.
Finally, last November, the FDA held a public hearing on DTC promotions of medical products, including pharmaceuticals, vaccines, blood products and medical devices, to obtain the public’s opinion as to whether and, if so, how the agency’s current regulations and interpretation of those regulations should be modified to better address DTC advertising.
These recent activities suggest that the FDA is considering adopting a more stringent policy to regulate the content of DTC advertisements for restricted devices. The FDA will likely adopt some recommendations from its recent public hearing, including the suggestions that information about risks be presented in an easy-to-understand format and displayed more prominently in advertisements.
The FDA could also require medical device companies to more slowly present risk information in broadcast advertisements and add on-screen text information about these risks to make the information easier to follow.
The FDA might also consider delaying the use of DTC advertisements for new medical devices until physicians have become educated about the products.
It is unlikely, however, that the FDA would require mandatory agency review and approval of restricted devices prior to advertising these products. Pre-review of DTC advertisements would strain the agency’s budget and require an increase in FDA personnel and resources. As an alternative, the FDA could recommend that companies voluntarily submit their DTC advertisements for agency review.
Ultimately, companies that utilize direct-to-consumer advertisements for restricted devices should continue to follow the FDA’s few promotional restrictions. This relaxed regulatory environment, however, may be subject to change, and companies that market restricted devices should pay close attention to whether the FDA takes additional steps toward tightening DTC advertising restrictions.
James R. Ravitz is a partner and Amy Swift is a law clerk with the Food and Drug Practice of Arent Fox PLLC, a general practice law firm based in Washington, DC. For additional information, contact Ravitz.James@arentfox.com or (202) 857-8903.