H.R.1117 - Responsibility in Drug Advertising Act of 2025 (119th Congress)
Summary
H.R.1117, the Responsibility in Drug Advertising Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act to restrict direct-to-consumer (DTC) advertising of prescription drugs. The bill proposes a three-year moratorium on DTC advertising for newly approved drugs, with a waiver option if the Secretary determines advertising would have affirmative value to public health. It also grants the Secretary authority to prohibit DTC advertising of drugs with significant adverse health effects discovered post-approval.
Expected Effects
If enacted, H.R.1117 would likely reduce the influence of pharmaceutical advertising on consumer demand for new drugs, particularly in the initial years after approval. This could lead to more informed prescribing decisions by healthcare professionals and potentially reduce unnecessary drug use. The bill may also incentivize pharmaceutical companies to focus more on post-market surveillance and risk assessment.
Potential Benefits
- More Informed Healthcare Decisions: By limiting DTC advertising, the bill may encourage patients to rely more on their healthcare providers for information about medications.
- Reduced Unnecessary Drug Use: Restricting advertising could decrease patient demand for drugs that may not be the most appropriate treatment option.
- Enhanced Post-Market Surveillance: The bill incentivizes pharmaceutical companies to focus on post-market surveillance to avoid potential advertising restrictions.
- Public Health Protection: The Secretary's authority to prohibit advertising of drugs with significant adverse effects could protect public health.
- Focus on Evidence-Based Medicine: Limiting advertising may shift the focus towards evidence-based medicine and clinical guidelines.
Most Benefited Areas:
Potential Disadvantages
- Potential Delay in Access to Information: Patients may not learn about new treatment options as quickly without DTC advertising.
- Reduced Patient Autonomy: Some argue that restricting advertising limits patients' ability to make informed decisions about their healthcare.
- Economic Impact on Pharmaceutical Companies: Restrictions on advertising could reduce revenue for pharmaceutical companies.
- Increased Regulatory Burden: The Secretary's office would need to manage waiver applications and monitor post-market drug safety.
- Potential for Unintended Consequences: The waiver process could be subject to political influence or bias.
Most Disadvantaged Areas:
Constitutional Alignment
The bill's restrictions on direct-to-consumer advertising raise potential First Amendment concerns regarding freedom of speech, specifically commercial speech. However, the government has the power to regulate commercial speech that is misleading or promotes unlawful activity, and to ensure public health and safety. The bill attempts to balance these interests by allowing waivers and focusing on drugs with potential adverse effects.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).