Jason Page Chicago, IL January 8, 2026

The Honorable Robert Kennedy Jr. Secretary, U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

President Donald J. Trump's Advisory Council
The White House
1600 Pennsylvania Avenue, N.W.
Washington, D.C. 20500

Dear Secretary Kennedy and Members of President Trump's Advisory Council,

I am writing as a concerned citizen to highlight a critical issue in our healthcare system: the "profit lockhold" that prevents effective medications—whether synthetic, herbal, or otherwise—from reaching American patients simply because they lack patent incentives for pharmaceutical companies to pursue FDA approval. This systemic barrier stifles innovation in affordable treatments and denies access to compounds that have demonstrated high efficacy in other parts of the world, often outperforming modern, patented alternatives in safety and effectiveness.

As an example, consider Phenibut, a compound approved in Russia and other countries for treating anxiety and insomnia with proven results in clinical settings. Similarly, drugs like Piracetam, Tianeptine, and Meldonium are widely used abroad for cognitive enhancement, depression, and cardiac conditions, respectively, backed by international studies showing superior outcomes in some cases. Yet, these remain unapproved in the US not due to inefficacy or safety concerns alone, but because they are off-patent, offering no exclusive profitability to justify the billions in trial costs. This leaves Americans reliant on more expensive, sometimes less effective options, or turning to unregulated supplements with potential risks.

To break this profit-driven lockhold and prioritize patient outcomes over corporate incentives, I urge you to explore and implement the following suggestions:

1. Establish Government-Funded Clinical Trial Grants for Off-Patent Drugs: Create a dedicated HHS fund, perhaps modeled after the Orphan Drug Act, to sponsor FDA trials for promising foreign-approved or off-patent compounds. Prioritize those with robust international data showing efficacy superior to current standards, including herbal remedies like Kava or St. John's Wort if evidence supports them. This could be financed through a small levy on high-profit patented drugs or reallocating existing NIH budgets.

2. Offer Limited Exclusivity Periods for Repurposed or Imported Drugs: Amend FDA regulations to grant temporary market exclusivity (e.g., 3-5 years) to companies or nonprofits that invest in US trials for off-patent medications, even without new patents. This would incentivize private involvement while ensuring affordability post-exclusivity, freeing effective treatments from economic stagnation.

3. Streamline Reciprocal Approval Pathways with Trusted Allies: Develop fast-track FDA approval for drugs already vetted by rigorous regulators like the EMA (Europe) or PMDA (Japan), requiring only bridging studies for US populations. If a medication—herbal or synthetic—works better than modern equivalents abroad, mandate exploratory reviews to "free the lockhold" and make it available here, with safety monitoring.

4. Promote Public-Private Partnerships and Nonprofit Involvement: Encourage collaborations between HHS, universities, and nonprofits to conduct trials, reducing reliance on profit motives. President Trump's advisory council could lead by forming a task force to identify high-potential candidates, focusing on areas like mental health and chronic diseases where current options fall short.

These measures would align with President Trump's emphasis on reducing drug costs and bureaucracy while fostering American innovation. By shifting focus from patents to proven efficacy, we can unlock treatments that save lives, lower healthcare expenses, and empower patients. I respectfully request a response outlining any planned actions and am available to discuss further.

Thank you for your attention to this vital matter.

Sincerely,

Jason Page