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.

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.

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.

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.

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.

No Patient Left Behind (NPLB) wrote to the Centers for Medicare and Medicaid services (CMS) urging fixes to its plan for implementation of the Inflation Reduction Act. NPLB suggested fixes that will lower out-of-pocket costs for beneficiaries and protect small molecule innovation.

400+ biotech and pharma executives voice support for the FDA's indispensable role in regulating new medicines. The letter warns that judicial orders undermining the decisions of the FDA would destroy the basic infrastructure necessary for continued medical innovation.

No Patient Left Behind (NPLB) wrote to the Centers for Medicare and Medicaid services (CMS) warning that the exemptions of the Inflation Reduction Act fail to provide adequate protections for orphan drugs and other small molecule treatments.

33 investors whose funds manage $86B in capital detail the ways in which the imbalanced price setting provisions in the Inflation Reduction Act will warp investment in research and development and lead to fewer new cures.

1000+ Investors, researchers, patients, & innovators urge critical fixes to Senate Rx Bill that can lower Medicare Rx deductibles, give the government greater power to set prices, and make sure biopharma research and development remains vigorous for both small molecule treatments and biologics.

Biopharma patient advocates, innovators, and investors continue to urge Congress to fix the proposed Build Back Better (BBB) legislation to improve patient Rx affordability and preserve biopharma innovation.

Investors, economists, academics, and industry executives urge reforms to lower out-of-pocket costs. Price controls, they warn, could cease biopharma investment and prevent future cures.