As we indicated in our November 20th letter, No Patient Left Behind (NPLB)'s coalition of biotech investors, innovators, researchers, physicians, and patient advocates is deeply concerned about the direction of the FDA. We further wish to highlight and emphasize the issues raised in the December 3, 2025 Perspective published in the New England Journal of Medicine by twelve FDA commissioner predecessors.

This cartoon illustrates the absurdity of requiring “skin in the game” for life-saving, prescribed medications.

This cartoon simplifies the conversation on vaccines by reminding us of the obvious truth—vaccines are much better than the diseases they prevent.

This cartoon forces us to imagine a scenario where we let biotech innovation come to a grinding halt.

This cartoon explains the real rationale behind direct-to-consumer advertising for prescription drugs.

This cartoon serves as a stark reminder that measles is not just a childhood rash and should not be treated as such.

This cartoon exposes the truth. No one would fake cancer for free chemo, yet real patients can’t afford it. The satire forces discomfort where it belongs—with those who have the power to fix a broken system.

This cartoon personifies global free-riding on American tax-funded biopharmaceutical innovation.

This cartoon flips the usual debate about vaccines. You don’t need to know everything about vaccines to know one thing for sure: measles kills.

This cartoon tells the story of the MA Paradox—where patients turn against the very industry working to develop life-saving treatments.

This cartoon depicts the home mortgage analogy for drug innovation and the global free-ride on Americans funding the system.

This cartoon compares chemo copays to firefighter copays, showcasing the absurdity of paying drug copays after paying premiums.

US biotech innovators and investors value FDA prioritizing the recruitment and retention of clinical, scientific and regulatory specialists who offer innovators the benefit of experienced, case-specific guidance and problem-solving. This institutional expertise is especially important to small, early-stage, and pre-commercial US biopharma entrepreneurs, who account for the majority of new drug and biologic applications submitted to the FDA.

I know my insurance company’s hold music by heart.

My doctor says I need this. I’ve been paying my premiums. I don’t understand the problem.

So your insurance company decided they know medicine better than your actual doctor?

This Issue Brief presents new data showing that, despite increased federal subsidies and enrollment since 2022, many ACA exchange plans have raised OOP drug costs—undermining the law’s core promise of affordable care.

Our modern world needs a modern FDA with the capacity to accelerate access to safe, effective treatments while sustaining U.S. leadership in biotechnology. PDUFA VIII offers a historic opportunity to make the drug review program faster, more consistent, and more transparent by prioritizing core review activities, modernizing processes, strengthening accountability, and embracing patient-centered science.