Senators Dick Durbin of Illinois and Mike Braun of Indiana recently introduced bipartisan legislation aimed at closing regulatory loopholes by having the Food and Drug Administration (FDA) address false and misleading prescription drug promotions by social media influencers and telehealth companies, the Protecting Patients from Deceptive Drug Ads Online Act.
The FDA is responsible for ensuring that promotions by manufacturers are accurate, that risks and benefits are properly disclosed, and that the information on the FDA-approved label is shared with consumers. However, when it comes to influencers and telehealth companies, there is currently a gap in FDA’s oversight and there are many such promotions that provide false information, leave out key side effects, or generate demand for medications that may not be appropriate for a patient.
The Protecting Patients from Deceptive Drug Ads Online Act would essentially allow the FDA to enforce the same accurate information requirement in social media advertising as exists for ads on television, in newspapers, and other consumer-facing media.
Under the legislation, the FDA would issue warning letters – and fines for noncompliance – to influencers and telehealth companies that engage in communications that result in a financial benefit to the speaker/promoter and that contain false or inaccurate information, omit labeling or other key acts regarding a medication, or fail to include traditional risk and side effect disclosures.
Importantly, the legislation specifically excludes statements that are made “in the course of bona fide patient care or medical research that are made by professionals engaged in such patient care or medical research” and “statements that describe the person’s own experience, opinion, or value judgment” from the definition of “false or misleading communications.”
The legislation would also require healthcare providers and pharmaceutical manufacturers to report payments to influencers in the Open Payments database to highlight the promotional activities the companies are engaging in through celebrities. It would also allow the FDA to use new analytical tools, enhance public education, coordinate with the Federal Trade Commission (FTC) by creating a task force to enhance monitoring and enforcement, and establish a process to notify drug manufacturers of content that violates the law.
The legislation directs the FDA to monitor social media communications, including comment sections and viral trends. It also provides $15 million in authorized funds to be appropriated each fiscal year from 2025 through 2029 to carry out the market surveillance of prescription drug advertising or promotion on social media platforms.
“The power of social media and the deluge of false and misleading promotions has meant too many young people are exposed to inaccurate and harmful advice that promises quick fixes from certain medications,” said Senator Durbin. “And when an influencer or telehealth company is communicating for commercial gain and sharing deceptive medical content, this can place consumers at risk of severe and long-lasting side effects. Our bipartisan legislation would close loopholes that are exploited online by empowering FDA to protect patients from prescription drug advertisements lacking basic safety and accuracy information.”
“We need transparency in every part of the health care industry so Americans can make informed decisions about their health. If a company is making misleading claims about their drugs, that can have serious consequences on the health, safety, and wellbeing of Americans,” said Senator Braun.
Multiple associations have endorsed the bill, including the American College of Physicians, the American Academy of Family Physicians, the American Academy of Neurology, and Doctors for America.
For a link to the legislation as introduced, click here. The legislation has been referred to the Senate Committee on Health, Education, Labor and Pensions.