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The government’s repeated regulatory failures, especially within the FDA, have severely undermined public trust and contributed to the popularity of agenda-driven counterfactual figures like RFK Jr., Donald Trump, and Elon Musk.
The FDA’s long-standing underfunding and neglect of its public health mandate are evident in its overreliance on industry-supplied data and problematic approval pathways like the 510(k) process, which allows many medical devices to bypass rigorous testing.
These oversight systems, essentially controlled by corporate interests, have generated billions in profits while causing widespread public harm.
Key Examples of FDA Failures
- Purdue Pharma (OxyContin)
Approved in 1995, became a top-selling opioid painkiller because Purdue minimized its addictive risks and the FDA failed its public safety role.- Revenue: $35 billion in sales.
- Settlements: $7.4 billion: for misleading the public about addiction risks.
- Linked to over 500,000 opioid injuries and deaths, including Johnson & Johnson (Janssen Pharmaceuticals) Fentanyl.
- Merck (Vioxx)
Approved in 1999 without clear cardiovascular risk research data.- Revenue: $2.5 billion in sales.
- Settlements: $4.85 billion.
- Linked to 50,000-100,000 injuries and deaths.
- Johnson & Johnson (Talcum Powder) The company was aware of potential asbestos contamination in their talc-based baby powder as early as the late 1970s, decades before it was linked to ovarian cancer and mesothelioma, but the FDA did not intervene.
- Revenue (J&J 2024): $88.24 billion. (top selling since 1894; 2024 total talc market $1.36 billion).
- Settlements: $9 billion.
- Linked to tens of thousands of cancer cases.
- Fen-Phen
Approved in the 1990s, caused severe heart and lung issues, leading to a 1997 recall. The combination of fenfluramine and phentermine was also used for off-label weight loss.- Revenue: $305 million before the recall.
- Estimated settlements: $4.75 billion.
- Linked to 60,000 injuries and deaths.
- Selective Serotonin Reuptake Inhibitors (SSRIs)
Approved in 1987, drugs like Prozac (Eli Lilly), Paxil (GlaxoSmithKline), and Celexa/Lexapro (Forest Laboratories) passed by regulators despite concerns about suicidal tendencies and violent behavior.- Revenue: Billions in combined sales (Prozac: $22 billion, Celexa/Lexapro: $313 million, Paxil: $11.6 billion, Zoloft/sertraline: $3 billion).
- Settlements: Eli Lilly’s Prozac: $50 million, Forest Lab’s Celexa/Lexapro: $313 million, GSK’s Paxil: $3 billion, Pfizer’s Zoloft/sertraline: $0 (case dismissed due to lack of accepted evidence).
- Linked to 125,000+ injuries worldwide, based on existing clinical data, court records, and scientific studies.
- DePuy Hip Implants (Johnson & Johnson)
Approved with minimal testing, these implants caused severe complications, leading to a 2010 recall.- Revenue: $5.4 billion.
- Settlements: $6.2 billion.
- Linked to 93,000 injuries.
Total Estimated Corporate Sales
These examples represent just a small portion of the problem. Estimates suggest that global sales from FDA-approved drugs and devices total $5.5 trillion.
Comparative Financial Oversight Failures
This issue is not limited to just the FDA; large-scale failures in financial oversight include:
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- 2008 Financial Crisis: Cost taxpayers $498 billion and was the result of systemic regulatory failure.
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Enron Scandal (2001): Cost investors $74 billion and cost taxpayers $3.2 billion, was the result of the failures of Sarbanes-Oxley Act.
For decades, Federal regulators, especially the FDA, have prioritized expeditious approvals and corporate profits ahead of public safety, authorizing poorly tested drugs and devices that have generated billions in revenue.
The agency relies almost exclusively on manufacturer-submitted data, frequently delays critical recalls, and even fails to enforce its own standards. Evidence indicates that regulatory capture influences up to 25 percent of its oversight in certain sectors.
The recent illegal firings by the Department of Government Efficiency have only deepened the crisis, further eroding enforcement capacity and suppressing internal dissent.
This is not just fallout from the recent Trump/Musk/DOGE chaos— it’s the culmination of decades of systemic failure.
Real change happens only when the public demands it. Here’s what you can do:
- Stay informed by following updates on FDA.gov and CDC.gov.
- Advocate for independent oversight by reporting concerns on sites like FDA MedWatch.
- Support full transparency through mandatory third-party testing and robust whistleblower protections.
Urge lawmakers to strengthen FDA oversight and enforcement.
FDA Gutted Under Trump, RFK Jr., With More Than Half of Senior Leadership Now Gone
From Biospace: “While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency, and human decency is as well.”
Foreign Government Subsidies and FDA Regulatory Failures Are Causing Drug Shortages in the United States: Here’s How to Fix It
The authors write, “The United States is suffering from the worst drug shortage crisis in recent history. Whether it is basic generic drugs, antibiotics, or chemotherapy drugs, patients, doctors, and hospitals are facing shortages that are claiming American lives and straining our nation’s health care system. … This crisis is the result of decades of offshoring our nation’s drug manufacturing capacity, massive failures by the U.S. Food and Drug Administration (FDA) to properly regulate and oversee foreign drug manufacturers, and a massive system of subsidies used by foreign governments to shift generic drug production away from the United States.”
At FDA Roundtable, Biotech Leaders Call for ‘Modernizing’ Regulation To Compete With China
The author writes, “The FDA hosted a roundtable on Thursday to discuss cell and gene therapy development with two dozen life science researchers and entrepreneurs, along with the heads of US health agencies. Overwhelmingly, the participants voiced concerns that developing treatments for rare diseases can be excessively costly and face unnecessary regulatory hurdles. Two prominent biotech leaders went even further, arguing that over-regulation is allowing China to overtake the US as the dominant biopharmaceutical force.”
FDA’s LDT Final Rule Rejected by Federal District Court in Texas
From Wilson Sonsini: “The US Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT Final Rule, which phases out the FDA’s enforcement discretion policy for laboratory developed tests (LDTs) and phases in device requirements starting in May 2025. But legal challenges against the LDT Final Rule have prevailed. On March 31, 2025, the US District Court for the Eastern District of Texas vacated the LDT Final Rule, declaring that LDTs are not devices regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Rather, the court determined that LDTs are professional services regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).”
Hearing Wrap Up: FDA Must Eliminate Red Tape, Promote Innovation to Root Out Illicit Products and Restore Trust in the Agency
From the House Committee on Oversight and Government Reform: “The FDA stumbled from crisis to crisis during the Biden Administration, failing in its core mission. Bureaucratic red tape, inefficiencies, and weak oversight have led to a surge in harmful products, food safety violations, and counterfeit drugs infiltrating the legitimate supply chain.”
Study Reveals Mismanagement of FDA Medical Device Reviews (From 2011)
From the Competitive Enterprise Institute: “The Food and Drug Administration’s 510(k) review process for medical devices has been severely mismanaged by agency officials, according to a new study published today by the Competitive Enterprise Institute. The FDA has added comprehensive new data and testing requirements that do not enhance patient safety, but the growing lack of transparency and predictability in the review process is leading to an exodus of pioneering research and development from the United States.”
How Will FDA Changes Reshape Drug Approval in 2025 and Beyond?
The author writes, “Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% RIF on April 1, which excluded drug, device, and food reviewers and inspectors, nonetheless sparked concern and speculation across the pharmaceutical industry. Former commissioner Robert Califf posted on LinkedIn, ‘The FDA as we’ve known it is finished.’ Over 200 biotech leaders signed a letter to Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bill Cassidy (R-LA) urging the government to ‘quickly preserve and restore’ the FDA’s core functions and avoid delays to promised drug-approval decision dates. A little over a month later, some of those fears have materialized, but many have not.”
Trump, Musk, & RFK Jr. Hollow Out HHS, Threatening Americans’ Health and Wellbeing
From the minority members of the Senate Committee on Appropriations: “US Senator Patty Murray (D-WA), Vice Chair of the Senate Appropriations Committee and a senior member and former chair of the Senate Committee on Health, Education, Labor, and Pensions (HELP), responded to the Trump administration’s mass firings across the Department of Health and Human Services (HHS) and its many subagencies, which are responsible for protecting Americans’ health and delivering essential health and social services. ‘Today, two billionaires are making good on their vow to take a wrecking ball to the Department of Health and Human Services and put Americans’ health and wellbeing at serious risk — and Republicans are letting them. These firings make a lot of sense if you believe measles spreading like wildfire is good — or think we should be slashing cancer research.”
Most Americans Distrust Trump, RFK Jr. On Health: Axios-Ipsos Poll (From December)
From Axios: “The public trusts Anthony Fauci more than President-elect Trump and his incoming health team as a source of medical information, according to the latest Axios-Ipsos American Health Index. But Robert F. Kennedy Jr.’s focus on safe food and nutrition clearly resonates with many Americans, who see chemicals and unsafe additives as a bigger health risk than climate change or infectious diseases.”
This Could Be RFK Jr.’s Most Costly Mistake
The author writes, “Robert F. Kennedy Jr. has already tarnished his legacy as Health and Human Services secretary with numerous false statements and questionable decisions about vaccines. Last week, he added yet another serious blunder: The federal government, his department announced, will pull more than $760 million committed to developing shots for bird flu. The money was invested by the Biden administration in response to growing concern that the H5N1 avian flu was spreading in farms and infecting workers. Specifically, Biden officials contracted with Moderna to use its mRNA platform — the same technology that enabled the coronavirus vaccines to be produced in record time — to expedite the avian flu vaccine.”
FDA Chief Wary of Federal Recommendations for COVID-19 Vaccines
From Politico: “Dr. Marty Makary, commissioner of the FDA, on Sunday made it clear he was dubious of previous federal recommendations on COVID-19 vaccinations and the agencies who made them. In an interview with host Margaret Brennan of CBS’ ‘Face the Nation,’ Makary responded to repeated requests from Brennan to clarify federal guidance (or the lack thereof) with variations on the same answer. ‘We believe the recommendation should be with a patient and their doctor,’ he said at one point, declining to give specific advice — or specifying how doctors might be able to offer guidance in the absence of informed direction from the federal government.”
The Dizzying Rise of MAHA Warrior Calley Means, RFK Jr.’s Right-Hand Man
From Vanity Fair: “One of the primary architects of the Make America Healthy Again takeover of the federal health apparatus, Means has risen to power in part on the strength of his personal narrative: he was a Big Food and Big Pharma lobbyist who saw the light. Yet, a six-month Vanity Fair investigation raises questions about whether Means has embellished his personal story. ‘Calley Means is not a whistleblower. He is an opportunist, peddling junk science to make millions,’ says his former boss and mentor Steve Schmidt.”
FDA Reform Is Finally Here
From The Michigan Daily: “For decades, the FDA has failed to protect consumers and ensure food safety. Despite overseeing 80% of the US food supply, the FDA has been notoriously slow to respond to public health crises, often neglecting serious health concerns and engaging in troubling levels of industry collusion. In 2022, a government probe found that the FDA had inadequately regulated baby formula, leading to increased severe illness and exposure to lead and heavy metals. This exposure can permanently alter a child’s brain development, leading to lower IQ outcomes and behavioral disorders. For years, the FDA also failed to regulate artificial food dyes, despite repeated scientific studies showing their carcinogenicity in rats and negative behavioral impacts on children. These regulatory errors reveal an incompetent and neglectful FDA that has put American lives at risk.”
