Prohibit & Criminalize Private Funding of FDA
Criminalizing Private Funding of the FDA to Ensure Regulatory Integrity
Executive Summary
The Food and Drug Administration (FDA) is tasked with protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. However, the influence of private funding on the FDA raises significant concerns about conflicts of interest and the agency's ability to operate independently. This executive summary outlines the rationale for criminalizing private funding of the FDA to ensure regulatory integrity and proposes actionable steps to achieve this goal.
Rationale for Criminalizing Private Funding
Conflict of Interest:
Independence: Private funding from pharmaceutical companies and other stakeholders can lead to conflicts of interest, compromising the FDA’s independence and objectivity. Criminalizing private funding ensures that the FDA's decisions are based solely on scientific evidence and public health considerations.
Public Trust: Eliminating private funding enhances public trust in the FDA. When the public perceives the FDA as a neutral and unbiased regulator, confidence in approved drugs, vaccines, and medical devices increases.
Regulatory Capture:
Preventing Regulatory Capture: Private funding can lead to regulatory capture, where the agency becomes more aligned with the interests of the industry it is supposed to regulate. Criminalizing private funding helps prevent this capture and maintains the FDA's role as a watchdog for public health.
Ensuring Rigorous Standards: Without the influence of private funding, the FDA is more likely to enforce rigorous safety and efficacy standards, ensuring that only safe and effective products reach the market.
Scientific Integrity:
Focus on Science: Ensuring that the FDA is funded exclusively by public sources prioritizes scientific integrity and evidence-based decision-making. This focus is crucial for maintaining high standards in drug and device approval processes.
Transparency and Accountability: Public funding enhances transparency and accountability within the FDA. It allows for clearer oversight and more straightforward scrutiny of the agency's operations and decisions.
Legislative and Policy Recommendations
Enact Legislation to Ban Private Funding:
Federal Ban: Introduce and pass federal legislation that explicitly bans private funding of the FDA. This legislation should criminalize any form of direct or indirect private financial contributions to the agency.
State-Level Measures: Encourage states to adopt complementary measures that reinforce the federal ban and ensure no loopholes for private funding at state or local levels.
Establish Alternative Public Funding Mechanisms:
Increased Federal Budget Allocation: Ensure the FDA receives sufficient funding through federal budget allocations. This increase in public funding will allow the FDA to operate effectively without reliance on private contributions.
Public Health Levy: Implement a modest public health levy on pharmaceutical sales to fund the FDA. This levy should be structured to avoid direct financial ties between specific companies and the FDA, thus maintaining the agency’s independence.
Strengthen Oversight and Governance:
Independent Oversight Body: Create an independent oversight body to monitor the FDA's funding and operations. This body should ensure compliance with the ban on private funding and provide regular reports to Congress and the public.
Transparency Requirements: Mandate rigorous transparency requirements for all FDA funding and expenditures. The agency should publicly disclose detailed information about its financial sources and how funds are utilized.
Enhance Public Engagement and Accountability:
Public Advisory Committees: Establish public advisory committees to provide input on FDA policies and decisions. These committees should include representatives from patient advocacy groups, healthcare professionals, and independent scientists.
Regular Audits and Reports: Conduct regular audits of the FDA’s financial and operational activities. These audits should be made publicly available to ensure accountability and build public trust.
Case Study: Approving Untested Drugs
https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html
Case Study: Denying Citizens Petition for Protection
In July 2023, the U.S. Food and Drug Administration (FDA) denied a petition requesting that the agency reconsider its denial of a citizen petition issued on May 19, 2022. The citizen petition requested a ban on the use of eight ortho-phthalates and revocation of the prior sanctioned uses for five ortho-phthalates in food based on alleged safety concerns.
Ortho-phthalates, often referred to as “phthalates,” are chemicals used in plastic products (most commonly in the specific type of plastic named polyvinyl chloride, also known as PVC or vinyl) to make the material soft and less brittle.
The FDA has authorized the use of nine phthalates in food contact applications, such as food packaging and processing materials, for decades. However, phthalates can leach into food and beverages, including milk, meat, seafood, and baked goods. In 2016, nonprofit organizations filed petitions with the FDA to ban phthalates, but the FDA denied them in 2022 and again in 2023.
The European Union (EU) bans phthalates and acknolwedges their health risks to their citizens.
This example is one of countless that demonstrate the FDA exist to maintain regulatory capture on behalf of corporations while sacrificing the well-being of We The People of the United States.
Conclusion
Criminalizing private funding of the FDA is essential to safeguard the agency’s integrity, independence, and ability to protect public health effectively. By implementing these legislative and policy recommendations, we can ensure that the FDA operates free from conflicts of interest, maintains high standards for safety and efficacy, and enjoys the public trust necessary for its critical role in the healthcare system.
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