💵 The Harley Jacobsen Clinical Trial Participation Income Exemption Act seeks to exclude all payments to participants in clinical trials from being treated as taxable income so welfare benefits are not put at risk.

🕒 Updates to the Family and Medical Leave Act would formally recognize clinical trial participation as a valid reason for medical leave and significantly ease the burden on participants and caregivers alike.

🧠 The Medicare price negotiations under the Inflation Reduction Act (IRA) are adding more risk and uncertainty to an extremely complex field of research. Unlike other disease areas, mental health drug development faces unique scientific, clinical, and regulatory hurdles, and as a result, it takes 20% longer to develop a CNS drug than other types of medications, CNS medicines take 38% longer to receive regulatory approval due to the complexities of mental health research, and clinical trial success rates for CNS drugs are just 6.2%—less than half the success rate of medicines for other conditions (13.3%). This is why the IRA needs to be modified to make CNS medications exempt from the CMS price negotiations.
💊 The EPIC Act would eliminate the so-called “pill penalty” by aligning the IRA’s price-setting timeline for small molecule medicines with that of other therapies—setting prices 13 years after FDA approval rather than 9. This change is critical for the future of brain-focused treatments.

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To our site and pharmaceutical members:

  • Are there policy issues or participant support gaps you’d like to see addressed?
  • Which state policies or decisions would you like advocacy’s support on?
  • What barriers are you facing in study enrollment?
  • What challenges are you having building trust and visibility within the communities you serve?

Let us know and we can work on solutions together!