Comment from San Diego Regenerative Medicine Institute

Docket No. FDA-2026-N-2366 The FDA hasn’t given any details or guidelines or definitions to the public about the critical U.S. national health priorities and what products qualify for or align with the critical U.S. national health priorities, nor has the FDA provided any procedures or guidelines or frameworks to the public about how the FDA is able to maintain FDA's rigorous scientific and regulatory standards with such a ultra-fast review pathway of only 1-2 months. In addition, the FDA has never given any explainable reasons to the public why those products in the CNPV Program need such a ultra-fast review pathway of only 1-2 months, nor has the FDA been transparent with the public about their selection procedures and guidelines for those products in the CNPV Program in compliance with the FD&A Act and the PHS Act). As a result, the FDA CNPV program has taken advantage of those loopholes and become a revolving door for big Pharma and large institutional investors. Its early winners include Lilly, Novo Nordisk, Vertex, GSK, J&J, Boehringer, Regeneron, Sanofi, Merck KGaA, often as a deal in exchange for TrumpRx MFN (Most favored Nation) Pricing, and their smaller peers, all backed by large institutional investors such as Blackrock and Vanguard. All the early CNPV winners are well-known to the public for their lobbyists in both the FDA and the Whitehouse. All the early CNPV winners have been selected by the FDA behind closed doors through FDA internal nominations by FDA review divisions that often have big Pharma ties, and the FDA CNPVs have dramatically enhanced their stock prices. The FDA have never provided to the public any of the review documents or materials of those CNPVs to demonstrate that the FDA maintained its rigorous scientific and regulatory standards. Some of those products in the CNPVs are gene therapy or gene-editing therapy products, genetically engineered or modified products, or small molecule or inhibitor novel products, including Regeneron’s gene therapy product DB-OTO, Vertex’s Casgevy gene-editing therapy for sickle cell disease. Those CNPV novel products or drugs have very-high inherent oncogenic risks and require to follow the FDA strict regulatory guidelines and standard review timelines to ensure they meet the rigorous scientific and regulatory standards for safety and efficacy by the FD&C Act and the PHS Act. Those CNPV novel products or drugs would have never been approved by the FDA if the FDA had followed its standard regulatory guidelines and review processes in compliance with the FD&C Act and the PHS Act. The only common thing that those CNPV novel products or drugs share is that all those CNPV winners are backed by big Pharma and/or the same large institutional investors such as Blackrock and Vanguard, and the FDA CNPVs have dramatically enhanced their stock prices and added a huge chuck of money into their pockets, which violate the FD&C Act, the PHS Act, and government anti-corruption acts. None of the products in the CNPVs really align with the critical U.S. national health priorities. The FD&C Act and the PHS Act never give the FDA the authority to implement such revolving doors for big Pharma and large institutional investors in the FDA in the name of CNPVs. This corrupt CNPV program is apparently not consistent with FDA's mission to promote and protect the public health. To comply with the FD&C Act and the PHS Act, to maintain FDA's rigorous scientific and regulatory standards, to protect public health, the FDA should not use such a ultra-fast review pathway of CNPVs for drugs or products with high healthy risks and/or cancer risks, such as genetically-engineered drugs or products, gene therapy products, gene editing products, any drug or product containing oncogene, oncogenic molecules or chemicals or drugs or products, any drug or product with known risks for myocarditis, dementia, strokes, diabetes, and/or other chronic diseases. The FDA should have oversight, procedures, and guidelines in place to address or mitigate conflicts of interest (COI) and revolving doors in FDA's practice of accepting internal nominations by FDA review divisions and external statements of interest submitted by sponsors and applicants. The FDA should also consider practice of accepting public nominations for CNPVs. The FDA should also consider factors critical to the U.S. national health priorities in CNPV selection, including novel drugs or products that address major unmet health problems; disease urgency, such as ALS, strokes, heart attacks, terminal cancers; no existing treatment or cure available; no alternative life-style change solution; providing better treatment or new cures; really making a high impact on public health; innovative breakthrough therapy that is commonly accepted as safe, such as stem cell therapy product or regenerative medicine advanced therapy product based on a primary, unmodified human stem cell line. X