The Food and Drug Administration

The Food and Drug Administration

 

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The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. It was officially established in 1906 with the passage of the Pure Food and Drug Act, signed into law by President Theodore Roosevelt. This act aimed to curb the rampant mislabeling and adulteration of food and drug products, largely due to public pressure following muckraking journalism like Upton Sinclair’s The Jungle, which exposed unsanitary practices in the meatpacking industry. While the FDA in its earliest form can trace its roots to a bureau within the U.S. Department of Agriculture in the late 19th century, it wasn’t until the 20th century that it evolved into the more powerful regulatory body we know today.

 

The FDA is fully a government agency, not a quasi-governmental one like the Federal Reserve. It operates under the executive branch of the U.S. federal government and reports directly to the Department of Health and Human Services (HHS). The Commissioner of Food and Drugs, who leads the FDA, is appointed by the President and must be confirmed by the Senate. Therefore, the agency is part of the formal governmental structure and is subject to oversight by Congress, making it different from the semi-independent structure of the Federal Reserve, which has its own board and a unique funding mechanism.

 

Funding for the FDA comes from a mix of congressional appropriations (taxpayer money) and user fees. Over the past few decades, especially since the Prescription Drug User Fee Act (PDUFA) of 1992, a significant portion of its funding has come from fees paid by pharmaceutical companies, medical device manufacturers, and other industries the FDA regulates. These user fees are intended to help the agency speed up review processes for drugs and devices, but they have also raised concerns about regulatory capture and the appearance—or reality—of industry influence over the agency.

 

Checks and balances on the FDA are maintained primarily through congressional oversight, judicial review, and public accountability. Congress holds hearings, audits, and investigations into the agency’s actions and can pass legislation to change how it operates. Courts can review FDA decisions when they are challenged in lawsuits, providing a legal check on its regulatory power. Additionally, watchdog groups, journalists, scientists, and public interest organizations constantly scrutinize its decisions, especially around high-profile drug approvals or recalls. Despite this, critics often argue that the FDA walks a difficult line between protecting public health and being too close to the industries it regulates, particularly given its partial dependence on industry funding.

 

In essence, the FDA is a powerful arm of the federal government charged with overseeing a wide range of products that affect public health, from food and drugs to cosmetics and tobacco. Its authority is vast, but so are the challenges it faces in maintaining independence, transparency, and public trust.

 

As of recent years, the FDA operates with an annual budget of approximately $6 to $7 billion. This budget varies slightly year to year based on congressional appropriations and fluctuations in user fee collections. About 45% of this budget comes from federal taxpayer dollars through congressional funding, while the remaining 55% is generated through user fees paid by the industries the FDA regulates—primarily pharmaceutical and biotech companies, as well as medical device manufacturers. These user fees are intended to support specific functions, such as speeding up the drug approval process or post-market surveillance, though critics have long pointed out the potential for conflicts of interest when a regulatory agency receives substantial funding from the very industries it is meant to regulate.

 

The FDA employs over 18,000 people, including scientists, inspectors, doctors, pharmacists, statisticians, and administrative staff. Its workforce is highly specialized and spread across the United States, with a significant number working at the agency’s headquarters in Silver Spring, Maryland. A large portion of the staff is dedicated to scientific research, laboratory analysis, regulatory affairs, and field inspections. The FDA also maintains several labs and field offices to carry out inspections and research, both domestically and internationally, given the global nature of food and drug supply chains.

 

The FDA’s funds are allocated across several key areas, including drug and biologics regulation, food safety, medical devices, tobacco regulation, veterinary medicine, and research infrastructure. A considerable amount is also devoted to staff salaries, scientific equipment, and maintaining facilities. Specific programs—like the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER)—receive funding for evaluating new drugs and biologics such as vaccines. Additionally, post-market surveillance, adverse event tracking, and international regulatory cooperation consume a substantial portion of the budget.

 

The question of how the FDA approved COVID-19 vaccines for widespread use so rapidly, including the perception that they were not tested on humans, is complex and deeply contentious. In reality, the vaccines authorized for emergency use, particularly the mRNA vaccines from Pfizer-BioNTech and Moderna, did undergo human clinical trials, including Phase 1 (safety), Phase 2 (dosing and side effects), and Phase 3 (efficacy on tens of thousands of participants). What made the process unprecedented was the speed at which these phases were launched—often overlapping—and the speed of regulatory review under Emergency Use Authorization (EUA) powers. EUA allows the FDA to authorize unapproved medical products or unapproved uses of approved products during a declared public health emergency when there are no adequate alternatives available.

 

The sheer scale of the rollout—billions of doses globally—coupled with government mandates, marketing campaigns, and suppression of dissenting views, led to the perception that oversight was either rushed or compromised. Critics argue that traditional vaccine development, which usually spans 5–10 years including long-term safety monitoring, was collapsed into months. Moreover, the FDA relied heavily on manufacturer-supplied data, which some see as a potential conflict, especially given the agency’s partial industry funding. While proponents assert that no corners were cut and the global health emergency justified swift action, others contend that there was a lack of transparency, limited long-term safety data, and inadequate space for public debate or medical dissent, which fueled distrust. Oversight existed, but in a highly politicized and compressed environment, it did not resemble the more deliberative processes of previous decades.

 

The Food and Drug Administration (FDA) has faced numerous lawsuits from various states concerning its regulatory decisions and the actions of pharmaceutical companies. One notable case involved Hawaii, where a court ordered Bristol Myers Squibb and Sanofi to pay $916 million for failing to disclose the reduced efficacy of the blood thinner Plavix in non-Caucasian populations. In Oklahoma, Johnson & Johnson was found responsible for contributing to the opioid crisis and was ordered to pay $572 million for its deceptive marketing practices. Additionally, Amgen settled for $71 million with 48 states and the District of Columbia over allegations of promoting drugs for unapproved uses. ​

 

These cases highlight concerns about the FDA's relationship with the pharmaceutical industry. Critics argue that the agency's reliance on user fees from drug companies creates potential conflicts of interest. For instance, the FDA's Center for Drug Evaluation and Research receives over $1 billion annually from industry user fees, leading some to question whether this financial dependence compromises the agency's objectivity. Furthermore, investigations have revealed that many patient advocacy groups consulted by the FDA receive significant funding from pharmaceutical companies, raising concerns about the impartiality of the input the agency receives. ​

 

The FDA's approval processes have also come under scrutiny. In the case of the opioid epidemic, the agency has been criticized for approving powerful painkillers without sufficient oversight, allegedly contributing to widespread addiction and misuse. Some former FDA advisers have accused the agency of having a "cozy" relationship with the pharmaceutical industry, suggesting that this closeness may have influenced its regulatory decisions to the detriment of public health. ​

 

These instances underscore the importance of ensuring that regulatory agencies like the FDA maintain independence and prioritize public health over industry interests. Ongoing scrutiny and reforms may be necessary to address these concerns and restore public trust in the agency's decisions.​

 

The Food and Drug Administration (FDA) collaborates extensively with non-governmental entities through various contracts, grants, and cooperative agreements. These partnerships are integral to the FDA's mission to protect public health, especially in areas like food safety, medical countermeasures, and regulatory science.​

 

In the realm of food safety, the FDA has established cooperative agreements with organizations such as the Association of Public Health Laboratories (APHL), which received over $500,000 to enhance laboratory procedures and data management systems. Additionally, the Flexible Funding Model (FFM) program supports 43 awardees, including state agencies, with over $9.7 million to advance food safety standards and emergency response efforts. The Association of Food and Drug Officials (AFDO) was also awarded $4.8 million to facilitate training and equipment purchases for state and territorial agencies involved in food safety programs .​

 

Beyond food safety, the FDA engages with non-governmental organizations to bolster medical countermeasures. For instance, the agency collaborates with the National Academies of Sciences, Engineering, and Medicine to coordinate disaster preparedness efforts. It also works with the National Association of County and City Health Officials (NACCHO) to support public health preparedness at various governmental levels. A notable partnership is with the Bill and Melinda Gates Foundation, focusing on developing over-the-counter diagnostics and evaluating vaccines .​

 

Financially, the FDA is a significant grant-making agency. In 2023, it awarded $273 million in federal assistance to various partners, including non-governmental organizations . These funds support a wide range of initiatives, from enhancing laboratory capabilities to improving regulatory compliance.​

 

While specific numbers detailing the total count of non-governmental entities the FDA contracts with are not readily available, the agency's extensive collaborations underscore its reliance on external expertise to fulfill its public health mandate. These partnerships enable the FDA to leverage specialized knowledge and resources, ensuring comprehensive oversight and innovation in its regulatory processes.​

 

To estimate the cost of employing 18,000 people at the FDA, we can use an average government employee compensation package as a benchmark. For federal employees, the average salary is around $90,000 annually, though this varies widely depending on the role, experience, and seniority. When factoring in full benefits—health insurance, retirement contributions, and other federal perks—the total cost per employee typically rises to about $130,000 to $150,000 annually. If we conservatively average that to $140,000, then the total cost of employing 18,000 people would be approximately $2.52 billion per year.

 

Given that the FDA’s total budget is around $6.5 to $7 billion annually, subtracting the $2.52 billion for personnel leaves roughly $4 to $4.5 billion in additional funding. This money is distributed across various programs and departments—drug approvals, food inspections, lab testing, tobacco regulation, veterinary oversight, research, information technology, international operations, and administrative infrastructure. A significant portion of the remaining funds goes to third-party contracts, grants, cooperative agreements, and user-funded fast-track systems like the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Amendments (MDUFA). These programs are partially funded by the industries being regulated, a setup that raises concerns about regulatory capture and misaligned incentives.

 

The potential for financial loopholes and mismanagement exists, particularly in how the FDA distributes grants, enters contracts with non-governmental organizations, and allocates industry-paid user fees. One key vulnerability is the lack of transparency and auditing around third-party relationships. For instance, organizations receiving FDA grants—such as the Association of Food and Drug Officials (AFDO), patient advocacy groups, or private laboratories—could hypothetically be overcompensated for services or serve as pass-throughs for padded consulting fees. Similarly, user fees from pharmaceutical companies are often designated for specific review functions, but the internal allocation of these funds within FDA departments can be opaque, leaving room for budget inflation or unnecessary project expansions.

 

Another questionable area is the FDA’s engagement with industry-funded “advisory” groups. These groups, which often receive millions in both public and private funds, are sometimes involved in policy discussions or fast-track decisions. While not outright fraudulent, these entanglements create a grey area where public funds could effectively serve private interests under the guise of regulatory collaboration. The revolving door between FDA officials and pharmaceutical companies—where former regulators take high-paid roles in the private sector—further fuels suspicions of mutual back-scratching and lax enforcement in return for future job prospects.

 

To prevent misuse, comprehensive independent audits would be required—something that watchdog groups have long advocated for. Yet, with complex and interwoven funding streams, identifying specific instances of fund misappropriation is challenging without insider whistleblowing or an official investigation. In summary, while the FDA’s budget is justifiable on paper due to the scale of its responsibilities, the potential for budgetary manipulation, excessive contracting, and covert influence remains very real and under-scrutinized.

 

Recent developments have raised concerns about the FDA's financial management and allocation of its substantial budget. In April 2025, the Department of Health and Human Services (HHS) implemented significant layoffs, terminating approximately 10,000 employees, including 2,500 from the FDA. These cuts affected personnel involved in critical areas such as food inspections, laboratory testing, and outbreak response. Prior to these layoffs, funding for state-level food safety programs had already been reduced, leading to delays in inspections and weakening the implementation of the 2011 Food Safety Modernization Act. Critics argue that these reductions compromise food safety and public health, especially amid increasing foodborne illness outbreaks. ​

 

Furthermore, the FDA's reliance on user fees from the pharmaceutical industry, which constitute nearly half of its annual budget, has come under scrutiny. Staff reductions have disrupted the agency's ability to review new medical products efficiently, potentially slowing access to new treatments and undermining the FDA's global reputation. ​

 

Concerns have also been raised about the FDA's transparency in budget execution. In a 2024 budget hearing, members of the House Appropriations Committee expressed apprehension over the lack of clarity regarding how the FDA utilizes its funds, particularly in the Foods program. They emphasized the need for more accountability and oversight to ensure efficient use of resources. ​

 

These issues underscore the importance of robust oversight and transparent financial practices within the FDA to maintain public trust and ensure the agency fulfills its mission effectively.​

 

If the FDA ends a fiscal year with unspent funds or what might appear to be a “surplus,” the destination of that money depends largely on the source of the funds and the rules attached to their use. Unlike a private organization, the FDA does not have free rein to save or reinvest excess funds however it chooses. All federal agencies operate under strict budgetary rules established by Congress, and any surplus funds—especially those from taxpayer appropriations—are typically subject to reversion, reallocation, or repurposing within the broader Department of Health and Human Services (HHS).

 

For congressionally appropriated funds, the FDA usually must return unspent amounts back to the U.S. Treasury at the end of the fiscal year unless otherwise authorized to carry them over. Some program-specific allocations, especially for multi-year projects, may be carried over if they were designated as such in the budget legislation. However, if they’re not spent within their allowable window, the funds lapse and cannot be reused unless reauthorized. This system is designed to prevent hoarding or misuse, but it doesn’t always prevent inefficiency or the appearance of financial waste.

 

User fees, which now make up nearly half of the FDA's budget, operate under slightly different rules. These fees—paid by drug makers, device manufacturers, and tobacco companies—are often allocated to dedicated accounts with more flexible usage timelines. In some cases, the FDA can carry over these funds for several years, using them to build up internal review capacity or fund infrastructure upgrades. However, this flexibility has also raised questions about transparency, since it allows the agency to build large reserves that are less scrutinized by Congress. In 2018, for instance, it was reported that the FDA had hundreds of millions of unspent user fees sitting in reserve accounts—money collected from private industry that had not yet been applied to any specific project or staffing effort.

 

Critics argue that this stockpiling of funds, particularly from user fees, creates an environment where the FDA becomes less incentivized to use resources efficiently. It can also blur the lines of accountability, especially when surplus funds are quietly rolled over into internal programs, contract extensions, or consulting fees that receive minimal public visibility. In such scenarios, it becomes difficult for external watchdogs to track whether that money truly benefits public health or simply contributes to bureaucratic bloat.

 

Ultimately, while legal mechanisms are in place to control what happens to surplus funds, the lack of detailed public reporting on year-end financials—particularly around non-appropriated income—means that the FDA retains significant discretion in how those funds are carried forward. This has led many transparency advocates to push for stronger oversight, mandatory audits, and clearer breakdowns of how every dollar—especially user-fee-derived income—is actually spent or reserved.

 

Yes, there have been documented instances where individuals within or associated with the FDA have misused funds or engaged in fraudulent activities, highlighting vulnerabilities in the agency's financial oversight.​

 

In one notable case, an FDA supervisor named Elvis Gordon was charged with bribery and conspiracy for directing FDA contracts to a company owned by a local businessman, Ivan Ponder. In return, Gordon received personal benefits, including a debit card linked to the company's bank account, which he used for personal expenses over several years. This case underscores how individuals in positions of authority within the FDA can exploit their roles for personal gain .​

 

Furthermore, investigations have revealed that the Department of Health and Human Services (HHS), which oversees the FDA, misappropriated millions of dollars intended for vaccine research and emergency preparedness. Funds allocated to the Biomedical Advanced Research and Development Authority (BARDA) were diverted to unrelated expenses, such as administrative costs and office renovations. This practice was so prevalent that it earned the nickname "Bank of BARDA" within the agency .​

 

Additionally, the FDA has faced criticism for approving drugs based on fraudulent research. In one instance, the agency allowed medications to remain on the market even after discovering that the research supporting their approval was compromised due to egregious violations at a major pharmaceutical research laboratory. This situation raises concerns about the FDA's commitment to ensuring the integrity of the data it relies upon for drug approvals .​

 

These examples illustrate that while the FDA plays a crucial role in safeguarding public health, there are instances where its processes and oversight mechanisms have been exploited. Such cases highlight the need for robust internal controls and transparency to prevent misuse of funds and ensure that the agency's actions align with its mission to protect public health.​

 

The claim that the FDA approved a COVID-19 vaccine specifically for a later strain (such as COVID-19 “variant 2” or SARS-CoV-2 subvariants), and not the original strain, is partly rooted in confusion over the language of approval and the process the FDA used during the pandemic. Let’s break this down clearly.

 

Initially, the FDA did not fully approve any COVID-19 vaccine for immediate widespread use. Instead, it issued Emergency Use Authorizations (EUAs)—a legal mechanism that allows the FDA to enable access to medical products during public health emergencies. These EUAs were granted based on preliminary clinical trial data showing that the benefits outweighed the risks during the height of the pandemic. Pfizer-BioNTech, Moderna, and Johnson & Johnson all received EUAs before formal FDA licensure.

 

In August 2021, the FDA fully approved the Pfizer-BioNTech vaccine under the brand name Comirnaty for individuals 16 and older. However, this approval applied to the original strain of SARS-CoV-2 that had already been widely replaced by variants like Delta and later Omicron. Despite this, the manufacturing process, formulation, and safety data were deemed sufficient for approval. This led to some public confusion: people believed they were taking a new or different vaccine than the one approved, when in fact the composition was essentially the same. Critics argued that since the virus had mutated significantly, the vaccine’s real-world efficacy against newer strains was diminished—and thus, people were being administered an outdated formula under the guise of it being “approved.”

 

Complicating things further, the approved version—Comirnaty—wasn’t widely available on shelves right away. Many doses being distributed were still technically under the EUA, leading to public frustration and skepticism. While legally the products were considered interchangeable under FDA guidance, detractors claimed this created a bait-and-switch scenario, where people were encouraged—or even mandated—to take a vaccine that was not technically the one fully approved.

 

Later, updated “bivalent” boosters were developed to better target new variants, and these too received EUAs before some were formally approved. This constantly shifting regulatory and scientific environment left many citizens unsure whether they were being protected by an officially sanctioned product or participating in what some framed as an ongoing experiment.

 

While the FDA maintains that all its decisions were made in accordance with the best available data and under the strictures of federal law, the evolving nature of the virus and the FDA’s layered regulatory language undoubtedly created space for mistrust and claims of impropriety. Whether this was a failure of transparency, messaging, or science-policy coordination remains a hotly debated topic.

 

Sources

 

https://www.fda.gov/food/funding-opportunities-provided-office-domestic-partnerships/grants-cooperative-agreements-food

https://www.fda.gov/food/federal-state-local-tribal-and-territorial-cooperative-human-food-programs/funding-opportunities-provided-office-domestic-partnerships

https://www.fda.gov/emergency-preparedness-and-response/medical-countermeasure-collaborations/other-mcm-collaborations-non-government-organizations

https://www.fda.gov/about-fda/doing-business-fda/grants-and-cooperative-agreements

https://time.com/7275746/food-safety-fda-layoffs/

https://www.axios.com/2025/04/08/fda-user-fees-cuts-drug-reviews

https://appropriations.house.gov/news/statements/harris-remarks-fy24-budget-hearing-food-and-drug-administration-prepared

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/doj-press-releases-involving-fda-oci/november-1-2017-fda-supervisor-and-local-businessman-charged-bribery-scheme

https://osc.gov/News/Pages/21-08-HHS-Misused-Millions-Emergency-Preparedness.aspx

https://www.propublica.org/article/fda-let-drugs-approved-on-fraudulent-research-stay-on-the-market