Representatives Angie Craig, John Joyce Lead Call for GAO Review of Direct-to-Consumer Advertising Practices for Medical Products

WASHINGTON, D.C. — Today, U.S. Representatives Angie Craig (D-MN) and John Joyce (R-PA) led 17 of their colleagues in requesting a review of the regulation of Direct-to-Consumer (DTC) advertising practices for prescription medical products. Over the past several years, an increasing number of companies are selling prescription products, such as contact lenses and orthodontics, directly to consumers. While these companies have the potential to increase convenience and lower costs, reports of poor quality or adverse events have raised concerns among consumers and health care providers.

In a letter to Comptroller General Gene Dodaro, Craig, Joyce and their colleagues requested that the U.S. Government Accountability Office (GAO) perform a study on the current practices and regulation of this emerging market, which could inform future regulatory and legislative action if needed.

"Although selling prescription medical products directly to consumers can create lower costs and increase convenience, the practices of new DTC companies have raised concerns about the safety and regulation of this industry," wrote the Members. "Doctors, former federal regulators and legal experts are concerned that these DTC companies are operating in a regulatory vacuum that could pose risks to public health."

"The rise of internet marketing and the push toward a DTC model of healthcare delivery represents a major change within our healthcare system. We are concerned that with the rapid growth of DTC advertising, appropriate regulatory oversight may be falling behind," the members continued.

Direct-to-consumer prescription medical products are typically marketed via television, social media, and the internet advertising and represent a shift in healthcare delivery. Within the federal government, these companies are generally regulated by the Food and Drug Administration (FDA) and Federal Trade Commission (FTC). However, neither agency has taken regulatory action against prominent DTC companies that sell prescription medical products that have received repeated consumer complaints about product quality and safety. The influence of companies like these has increased during the coronavirus pandemic and this model of DTC sales and marketing is representative of a broader trend in the healthcare industry. In their letter, the Representatives argued that more information is necessary to guide federal regulators and lawmakers as they consider actions to protect the health of American consumers.

The letter to Comptroller Dodaro was signed by Craig, Joyce and Representatives Cindy Axne (D-IA), Kelly Armstrong (R-ND), Brian Babin (R-TX), Gus Bilirakis (R-FL), Tony Cárdenas (D-CA), Tom Cole (R-OK), Diana DeGette (D-CO), Brian Fitzpatrick (R-PA), Ron Kind (D-WI), Morgan Griffith (R-VA), Debbie Lesko (R-AZ), David B. McKinley (R-WV), Jerry McNerney (D-CA), Mariannette Miller-Meeks (R-IA), Tom O'Halleran (D-AZ) Bobby L. Rush (D-IL) Jan Schakowsky (D-IL), Kim Schrier (D-WA) and Lori Trahan (D-MA).

The full text of the letter can be found

December 6, 2021

The Honorable Gene L. Dodaro
Comptroller General of the United States
U.S. Government Accountability Office
441 G Street, N.W.
Washington, D.C. 20548

Dear Comptroller General Dodaro:

We write to request that the Government Accountability Office (GAO) conduct a study of the federal regulation of Direct-To-Consumer (DTC) advertising practices for prescription medical products. Within the federal government, the Federal Trade Commission (FTC) is responsible for protecting consumers and competition and has, for example, issued a Contact Lens rule to lay out consumers' rights to shop around when buying contact lenses. The Food and Drug Administration (FDA) is responsible for the safety and efficacy of medical products and tracking adverse events related to medical products. Additionally, companies are required to submit promotional materials to the FDA for review once they are being used in the marketing of a drug and can take action if the agency finds that a drug advertisement or other promotion is false or misleading.

In recent years, there has been an increase in companies marketing prescription medical products directly to consumers via television, social media, and internet advertising. A previous survey of healthcare providers conducted by the FDA found DTC advertising presented both benefits and challenges to the doctor-patient relationship. While products advertised directly to consumers have the potential to increase convenience and lower costs to consumers, concerns have also been raised about reports of poor quality or adverse events related to these products. Additionally, some DTC products allow consumers to bypass evaluation or supervision by a healthcare provider entirely, which may be appropriate for some products and not for others. Two instances that provide an example of recent issues within this industry, having aroused repeated complaints and calls for each company to be investigated by the Federal Trade Commission and Food & Drug Administration:

• A mail-order orthodontics company that does not require typical in-person orthodontic visits faces allegations that they violated prescription labeling requirements established under the Federal Food, Drug and Cosmetic Act (FFDCA) and endangered consumers by not taking sufficient diagnostic steps prior to selling their orthodontic aligners, which has the potential to lead to long-term dental damage.
• An online distributor of contact lenses is accused of using older materials and switching prescribed lenses for other brands, which doctors allege affect the safety of the lenses. Advocacy groups and other complaints further allege that the company skirts existing prescription verification requirements under the FTC's Contact Lens Rule.

The rise of internet marketing and the push toward a DTC model of healthcare delivery represents a major change within our healthcare system. We are concerned that with the rapid growth of DTC advertising, appropriate regulatory oversight may be falling behind.

A GAO study into the ongoing practices and current regulatory oversight by federal agencies of these activities would provide valuable insight to guide potential regulatory and legislative action, if needed, in the future.

For these reasons, we request that the GAO review the practice of DTC advertising of medical products to consumers. Specifically, we would like you to examine the following:

1. What are the known advantages and concerns of marketing medical products that require prescriptions or other provider evaluation, such as contact lenses, directly to consumers?
2. What actions are federal agencies, such as the FDA and the FTC, taking to address any identified concerns?
3. Are there limitations to FDA or FTC's ability to enforce existing laws and regulations governing DTC advertising of prescription medical products and, if so, what are those limitations?

A GAO review of these issues will be an important step toward protecting consumers and towards mitigating any potential medical or public health harms that may arise from these marketing practices.