In response to President-elect Trump nominating RFK Jr. to become HHS Secretary

Effective age regression interventions hold the potential to not only alleviate but also prevent diseases associated with aging. This groundbreaking assertion has garnered the endorsement of the majority within the scientific community who increasingly view aging not as a disease per se, but as the primary catalyst/cause for nearly all age-related diseases.

Diseases caused by aging represent a staggering 85% of all diseases that plague humanity. The pharmaceutical industry is acutely aware of this catastrophically negative financial inevitability. Although this is recognized as an inevitability it can and is being dramatically delayed through regulatory obstruction.

Approximately 45% of the FDA's total budget comes from user fees paid by biotechs and pharmaceutical companies. These fees are collected for various regulatory oversight activities, including the approval processes for new drugs, generic drugs, biologics, biosimilars, and medical devices. Specifically, 75% of the funding for human drug regulatory activities at the FDA is derived from these user fees.

This financial structure creates a significant dependency of the FDA on these fees. The reliance on user fees means that a substantial portion of the FDA's operational budget is directly tied to the industry it regulates. This dependency can potentially influence the agency's priorities and decisions, as it must maintain a steady flow of these fees to sustain its regulatory functions and meet performance goals.

The arrangement, established and expanded through acts like the Prescription Drug User Fee Act (PDUFA), was intended to expedite the drug approval process, but it also raises concerns about the balance between ensuring public safety and catering to the financial interests of the pharmaceutical industry.

This situation is further complicated by the well-trodden path of FDA senior management transitioning to high-paying roles within the pharmaceutical industry they once regulated. Such movements raise critical questions about the objectivity and integrity of regulatory decisions, especially when those decisions might affect future employment opportunities in the industry.

Simply stated, the FDA is in large part beholden to the pharmaceutical industry for both financial support and career advancement of the employees.

How unbiased and effective are you as a regulator when you are talking to your future employer? One who will be paying you many multiples of your current salary.

Because of this incestuous co-dependance, the FDA is now compromised both from a regulatory perspective and an ethical one. Real conflicts of interest currently color their decisions on which drugs become available or are denied to the general population.

Currently, as you read this, the FDA has been actively preventing Spectrum’s distribution of fully audited and accredited plasma from healthy sex-identified 18-25-year-old donors (yFFP®) outside of Texas since March 25, 2019, a highly effective and quantumly active age regressive therapeutic that has been legally approved for medical use since 1938.

This therapeutic holds the potential to displace a large percentage of drugs currently in the marketplace and already in development for diseases related to aging. This represents a real threat to investors, the pharmaceutical industry, and the FDA.

We possess a treasure trove of FDA documentation and communications that exposes what amounts to a criminal conspiracy to prevent the distribution of this approved, effective, and annually documented for a quarter-century to be extraordinarily safe, therapeutic.

The implications of these findings are vast, not just for the field of gerontology and age-regression, but for public health at large. Medicare is a few years away from running out of funding. Effective age regression therapies can play a large role in resolving this looming healthcare disaster while allowing people to live more fulfilling lives.

The conflict of interest inherent in the current FDA approval process is a fundamental problem, baked into the structure of the system by controlling legislation. This dependency on user fees from the biopharmaceutical industry undermines the integrity of regulatory oversight, potentially compromising the health and well-being of all Americans.

It is crucial that these conflicts of interest are brought to light and addressed, to ensure that the health and well-being of all citizens are prioritized over regulatory self-preservation and pharmaceutical industry profits.

Tom Casey