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Protecting Patients from Deceptive Drug Ads Act

USA119th CongressS-652| Senate 
| Updated: 2/20/2025
Richard J. Durbin

Richard J. Durbin

Democratic Senator

Illinois

Cosponsors (1)
Roger Marshall (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The "Protecting Patients from Deceptive Drug Ads Act" seeks to regulate communications regarding prescription drugs by holding social media influencers and healthcare providers accountable for false or misleading statements. It amends the Federal Food, Drug, and Cosmetic Act to impose civil penalties on individuals who knowingly or recklessly make promotional communications on social media for financial benefit that contain false information, material omissions, or fail to include required brief summaries of side effects, contraindications, and effectiveness. The bill defines "false or misleading communications" and explicitly excludes statements made during bona fide patient care or medical research, as well as personal experiences or opinions. It also defines a "social media influencer" as an individual with perceived credibility who promotes information or products on social media. The Secretary of Health and Human Services is directed to issue guidance within 180 days to administer these new provisions, detailing factors for determining misleading communications and compliance. Furthermore, the legislation expands the definition of "manufacturer, packer, or distributor" under drug advertising regulations to include entities that use electronic means to connect patients with prescribers for drug dispensing, such as telehealth providers. It also mandates that payments from drug manufacturers to healthcare providers or social media influencers, and from healthcare providers to social media influencers, for drug promotion must be publicly reported under the Sunshine Act. To bolster oversight, the bill authorizes the Secretary to conduct market surveillance of prescription drug promotion on social media platforms, including using AI for analysis, engaging with platforms, and developing educational materials. It also allows for hiring additional FDA staff and establishing a joint task force with the Federal Trade Commission to coordinate monitoring and compliance efforts. The bill authorizes $15 million annually for fiscal years 2025 through 2029 to support these market surveillance activities and requires public reporting of enforcement actions.
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Timeline

Bill from Previous Congress

S 118-5040
Protecting Patients from Deceptive Drug Ads Online Act
Feb 20, 2025
Introduced in Senate
Feb 20, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S1129-1130)
  • Bill from Previous Congress

    S 118-5040
    Protecting Patients from Deceptive Drug Ads Online Act


  • February 20, 2025
    Introduced in Senate


  • February 20, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S1129-1130)

Health

Administrative law and regulatory proceduresCivil actions and liabilityCongressional oversightDepartment of Health and Human ServicesGovernment information and archivesHealth technology, devices, suppliesInternet, web applications, social mediaManufacturingMarketing and advertisingPrescription drugs

Protecting Patients from Deceptive Drug Ads Act

USA119th CongressS-652| Senate 
| Updated: 2/20/2025
The "Protecting Patients from Deceptive Drug Ads Act" seeks to regulate communications regarding prescription drugs by holding social media influencers and healthcare providers accountable for false or misleading statements. It amends the Federal Food, Drug, and Cosmetic Act to impose civil penalties on individuals who knowingly or recklessly make promotional communications on social media for financial benefit that contain false information, material omissions, or fail to include required brief summaries of side effects, contraindications, and effectiveness. The bill defines "false or misleading communications" and explicitly excludes statements made during bona fide patient care or medical research, as well as personal experiences or opinions. It also defines a "social media influencer" as an individual with perceived credibility who promotes information or products on social media. The Secretary of Health and Human Services is directed to issue guidance within 180 days to administer these new provisions, detailing factors for determining misleading communications and compliance. Furthermore, the legislation expands the definition of "manufacturer, packer, or distributor" under drug advertising regulations to include entities that use electronic means to connect patients with prescribers for drug dispensing, such as telehealth providers. It also mandates that payments from drug manufacturers to healthcare providers or social media influencers, and from healthcare providers to social media influencers, for drug promotion must be publicly reported under the Sunshine Act. To bolster oversight, the bill authorizes the Secretary to conduct market surveillance of prescription drug promotion on social media platforms, including using AI for analysis, engaging with platforms, and developing educational materials. It also allows for hiring additional FDA staff and establishing a joint task force with the Federal Trade Commission to coordinate monitoring and compliance efforts. The bill authorizes $15 million annually for fiscal years 2025 through 2029 to support these market surveillance activities and requires public reporting of enforcement actions.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 118-5040
Protecting Patients from Deceptive Drug Ads Online Act
Feb 20, 2025
Introduced in Senate
Feb 20, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S1129-1130)
  • Bill from Previous Congress

    S 118-5040
    Protecting Patients from Deceptive Drug Ads Online Act


  • February 20, 2025
    Introduced in Senate


  • February 20, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S1129-1130)
Richard J. Durbin

Richard J. Durbin

Democratic Senator

Illinois

Cosponsors (1)
Roger Marshall (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCivil actions and liabilityCongressional oversightDepartment of Health and Human ServicesGovernment information and archivesHealth technology, devices, suppliesInternet, web applications, social mediaManufacturingMarketing and advertisingPrescription drugs