Advocacy Marshall Bursis Advocacy Marshall Bursis

A Letter to Senate HELP Committee Chairman Bill Cassidy on Preserving and Modernizing the FDA

US biomedical innovators, the investors that support them, and the patients who depend on continued medical progress rely on the US Food and Drug Administration’s guidance and rigor to navigate policy and medical standards and to approve new medicines. The agency’s reorganization must preserve the institutional knowledge and core functionality that makes the FDA the world’s leading regulatory body.

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Advocacy Marshall Bursis Advocacy Marshall Bursis

Public Comment: End Unfair Trade Practices in Drug Pricing

When other countries pay less for drugs, they are free-riding on American innovation and our willingness to pay for new treatments. Forcing manufacturers to charge the same price that these other countries do would backfire. Instead, policymakers should use trade negotiations to pressure other wealthy countries to pay their fair share. No Patient Left Behind wrote to the Office of the United States Trade urging an end to unfair trade practices in drug pricing.

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Advocacy Marshall Bursis Advocacy Marshall Bursis

Public Comment: Use tariff and market access tools to force OECD countries to pay their fair share for medical innovation

No Patient Left Behind wrote to the Office of the United States Trade Representative regarding the 2025 Special 301 Review, urging the agency to use its tariff and market access tools to force OECD countries to pay their fair share for medical innovation and end the free-riding of American biomedical innovation.

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Advocacy Marshall Bursis Advocacy Marshall Bursis

Open letter to President Trump from biopharma innovators, investors, and patient advocates regarding proposed FDA budget and personnel cuts.

The independence and autonomy of the Food and Drug Administration (FDA) is a key part of ensuring that the biotech innovation ecosystem can continue to thrive. As an agency, it is the gold standard globally for determining risk-reward benefit in therapies for patients, and the world looks to it to lead the way. The people at the FDA facilitate the medical progress we all enjoy, and their work is a service to the American public.

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Advocacy Marshall Bursis Advocacy Marshall Bursis

Defending the NIH, the NSF, and the foundation of American science

There is an assault on the foundation of U.S. science. Recent actions—including arbitrarily restricting scientists' ability to speak and travel and stalling the dispersal of previously awarded NIH and NSF funds—are more than bureaucratic disruptions. They are an assault on the foundation of biomedical and technological progress.

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Advocacy Marshall Bursis Advocacy Marshall Bursis

Public Comment: Allow Medicare to cover anti-obesity medications (AOMs) and strengthen patient protection “guardrails” through better oversight of Medicare Advantage Part D (MAPD) plans.

No Patient Left Behind (NPLB) wrote to the Centers for Medicare and Medicaid services (CMS) urging the agency to allow Medicare to cover anti-obesity medications (AOMs) and to strengthen patient protection “guardrails” through better oversight of Medicare Advantage Part D (MAPD) plans.

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Advocacy Marshall Bursis Advocacy Marshall Bursis

NEW LETTER: Investors and executives urge the Congressional Budget Office to adopt changes to its modeling

CBO’s ability to correctly model investor decision-making is vital to our country’s ability to establish policies that achieve lasting biomedical affordability and continued innovation. In support of CBO’s efforts to improve its model, this letter emphasizes a number of economic and financial first principles, notably that investment is incentivized by expected returns based on discounted profits, not revenue, and adjusted for expected dilution from financings.

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Advocacy Marshall Bursis Advocacy Marshall Bursis

Sign-on letter: Why Fixing the IRA Matters to all of us

Under the drug pricing provisions of the Inflation Reduction Act, small molecule treatments will face Medicare “negotiation” (price setting) that makes brand medicines functionally generic just 9 years after FDA approval. This policy will unwisely skew investment towards harder to manufacture biologics and away from small molecule treatments for diseases of aging. Without both kinds of medicines, we will all be worse off.

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