Durbin, Braun Introduce Protecting Patients From Deceptive Drug Ads Online Act

09.12.24

Durbin, Braun Introduce Protecting Patients From Deceptive Drug Ads Online Act

With the rise in social media, new bipartisan legislation would address false & misleading prescription drug promotions from influencers & telehealth companies

WASHINGTON - U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Mike Braun (R-IN) today introduced the Protecting Patients from Deceptive Drug Ads Online Act, bipartisan legislation that would protect public health and close 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 prevalence of online promotions and direct-to-consumer advertisements for prescription drugs-such as weight loss, gastrointestinal, or psychiatric medications-has drastically increased in recent years, notably through influencers and telehealth companies on social media platforms such as TikTok and Instagram. FDA oversees manufacturer-sponsored prescription drug advertisements by ensuring that promotions by manufacturers are accurate, risks and benefits are disclosed, and information on the FDA-approved label is shared. However, there is generally a gap in FDA's oversight when it comes to many advertisements by influencers and telehealth companies. Too many of these promotions provide false information, omit key side effects, or fuel demand for medications that may not be appropriate for a patient.

"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 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," saidBraun.

"Young adult patients have been exposed to misleading prescription medicine advertisements for far too long, putting their health at risk. This legislation marks a crucial step in protecting all patients, especially young adults who are more vulnerable to such advertisements, by empowering the FDA with increased capacity and clearer enforcement guidelines. It creates a safer online environment where young patients can more confidently navigate health-related posts. We at Generation Patient proudly endorse this legislation, recognizing its potential to impact both current and future generations of patients positively. Thanks to Senators Durbin and Braun for listening and working with patients to develop this critical legislation." - Sneha Dave, Executive Director, Generation Patient

"American's exposure to health and medical news is exploding. Social media communicators are often extremely skillful at reaching audiences and engendering trust. And many people find messages on social media more accessible, timely, and entertaining than traditional sources. Social media can have a positive influence on public health if it is getting reliable messages out to the public. But because messages are often unreliable, social media can also cause important harm. It is often not easy for audiences to distinguish reliable from unreliable information. This bipartisan bill is an important step in the right direction by trying to address regulatory loopholes that allow social media communicators to disseminate inaccurate or misleading messages about the benefits, harms and uncertainties of prescription drugs."- Dr. Steven Woloshin, Professor of Medicine, Dartmouth Institute & Lisa Schwartz Foundation for Truth in Medicine.

"This legislation offers more transparency for all stakeholders and allows patients to better make informed decisions. The FDA guidance has long been outdated and there needs to be more done to protect patients and vulnerable populations. This legislation demonstrates the need for more guidance and more regulation." - Erin Willis, Ph.D., MPH, Associate Professor, University of Colorado Boulder

The Protecting Patients from Deceptive Drug Ads Online Act would address false and misleading prescription drug promotions by having FDA issue warning letters, followed by fines fornoncompliance, to influencers and telehealth companies that engage in communications that accrue a financial benefit to the speaker and contain false or inaccurate statements, omit labeling or other key facts regarding a medication, or fail to include traditional risk and side effect disclosures. The legislation includes commonsense exemptions to limit the scope of the legislation to flagrantly deceptive commercial speech.

Additionally, the legislation would require pharmaceutical manufacturers to report payments to influencers to the Open Payments database-similar to the existing disclosure of payments to physicians and other health providers-to shine light on promotional activities, including through celebrities. The legislation would enhance FDA's visibility of social media promotions by utilizing new analytical tools, enhancing public education, coordinating with the Federal Trade Commission (FTC), and establishing a process to notify drug manufacturers of violative content.

The Protecting Patients from Deceptive Drug Ads Online Act is endorsed by Generation Patient; American College of Physicians; American Academy of Neurology; American Academy of Family Physicians; American Association of Child and Adolescent Psychiatry; American College of Gastroenterology; American Psychological Association Services; Doctors for America; Public Citizen; Public Interest Research Group; Light Collective; Young People's Alliance; Connecting to Cure Crohn's and Colitis.

In February, Durbin and Braun sent a letter to FDA to take swift action to update its enforcement tools to reflect the current social media platforms and tactics used to promote prescription drugs, and to prioritize the protection of children from harmful and inaccurate medical advice.

A one-pager on the bill can be found here.

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