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RFK Jr. has it wrong — the FDA approves too few drugs
To some pundits and politicians, the Food and Drug Administration (FDA) recklessly approves medications that harm patients while padding the pockets of shareholders. For example, the new HHS Secretary Robert F. Kennedy Jr. has tried to get proven vaccines pulled from the market, casts dispersions on “pills and the potions and the powders” plaguing the health care system and thinks there’s some serious corruption between Big Pharma and the FDA. However, fresh evidence from the HHS’ watchdog shows the problem is not a pushover FDA. If anything, the problem is a risk-averse agency too eager to say “no.” The Trump administration needs to make sure patients continue to have access to the life-saving treatments they need. A recent report by the HHS inspector general confirms the FDA’s accelerated pathway for drug approval is working just fine. About nine out of 10 sped-up approvals are green-lit by the book via a “consistent approach” without “formal scientific disputes or informal disagreements.” And, even when the FDA approves more controversial drugs, skepticism by scientists leads to slow sales, insurer skepticism and even approval being yanked. For example, the sponsor of the controversial Alzheimer’s drug aducanumab announced it has stopped sales and further clinical testing of the drug because of (likely misguided) concerns about efficacy.
Arbitrary drug denials — not accelerated approvals — are the real problem at the FDA. In late 2024, the FDA rejected CAM2029, a treatment for a rare hormonal disorder called acromegaly, despite ample evidence that the medication was well-tolerated and improved patients’ lives. Regulators dwelled not on safety or efficacy but rather on “[manufacturing] facility-related deficiencies.” This is just the latest instance in a worrying trend of game-changing drugs being delayed for months or even years because of one-off production concerns with easy fixe According to Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research under the Biden administration, the agency’s approval standards are not getting stricter despite the uptick in manufacturing-related drug denials. Rather, the FDA is seeing “lesser quality in the facilities where these products are manufactured and we really need to work on this.” While Cavazzoni has a point that tainted medications and contamination are a far-too-common fact of life, timely and targeted recalls are a far better alternative to barring an entire medication. Imagine, for example, if the FDA withdrew approval for the diabetes drug metformin every time a manufacturing issue was identified. While patients would be a bit safer from probable carcinogens such as N-nitrosodimethylamine, they’d face a far tougher time keeping blood sugar levels in check. Life expectancy might even take a hit as a result of overly-strict policies. The FDA acknowledges this tradeoff and opts for a smarter and more tailored approach.
When in doubt, the FDA could also look beyond its borders and see what its international counterparts are doing. In January, the agency rejected a drug called zolbetuximab designed to treat gastric/gastroesophageal cancer. Similar to CAM2029, the issue was neither safety nor efficacy. According to clinical trial results, the medication improved median progression-free and overall survival by two to three months compared with just chemotherapy. The drug was held up due to “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility.” These issues apparently weren’t deal-breakers for the FDA’s Japanese counterparts, who green-lit the drug in March. It took the FDA seven months after the Japanese approval to finally grant American patients access to the life-extending medication. In its Oct. 18 approval press release, the agency boasted that the application “was granted priority review, fast track, and orphan drug designation.” When the United States is still falling behind international approval times even after applying three different types of expedited tracks, there is clearly a need for reform. The FDA is not moving too quickly, but rather too slowly to approve game-changing medications. The Trump administration should keep this in mind as it prepares to shake up the U.S. health care system.
Summer Reading: Healthcare
It's tempting for politicians to paint the American healthcare system as private and unregulated. Lawmakers such as Sen. Ed Markey (D-Mass.) claim “Private equity firms and greedy corporate executives are using the health care system as a piggybank. But putting profit over patients results in substandard care, while health workers suffer, and communities are left to clean up the mess.” In reality, the problems facing the American healthcare system are the result of far too much government involvement. As Cato Institute scholar Michael Cannon aptly points out, “Data from the OECD showed that in the United States, the government controls a larger share of health spending than in the average OECD nation, and in all but seven other OECD nations. [...] [The US] Government controls a larger share of healthcare spending than in the United Kingdom or Canada, which have government-run, single-payer systems.” He added, “In other countries, their socialized health systems have budgets. The government puts a limit on how much it will spend. The government of the United States doesn’t do that. Medicare and Medicaid programs don’t have budgets.”
Medicare and Medicaid spending are key contributors to multi-trillion-dollar debts and deficits. According to the Centers for Medicare and Medicaid Services’ (CMS’) analysis of the latest available data (2023): “NHE [National Health Expenditures] grew 7.5% to $4.9 trillion in 2023, or $14,570 per person, and accounted for 17.6% of Gross Domestic Product (GDP). Medicare spending grew 8.1% to $1,029.8 billion in 2023, or 21 percent of total NHE. Medicaid spending grew 7.9% to $871.7 billion in 2023, or 18 percent of total NHE. ... The largest shares of total health spending were sponsored by the federal government (32 percent) and the households (27 percent). The private business share of health spending accounted for 18 percent of total health care spending, state and local governments accounted for 16 percent, and other private revenues accounted for 7 percent.” It certainly doesn’t help that a key trust fund underpinning Medicare is now expected to go broke three years sooner than previously thought—2033 instead of the previously-projected 2036. It also really doesn’t help that Medicare is now on the hook for the gusher of red ink generated by the U.S. Postal Service. Even modest attempts to slow down government healthcare spending are met with hysterical pushback by pundits and politicians. This was especially the case following the recent passage of the One Big Beautiful Bill Act (OBBBA), which instituted work requirements for Medicaid and more frequent eligibility checks. TPA senior fellow Ross Marchand notes, “[OBBBA] has become law, and misconceptions about the legislation are a dime a dozen. While many detractors from the left have slammed the (deeply-flawed) bill as cancelling the health coverage of nearly 20 million Americans, the truth is that the OBBBA’s Medicaid changes are far too small for what needs to be done.... The legislation stipulates that, to receive Medicaid benefits, individuals must be working, engaged in community service (e.g., volunteering) or receiving education or work training at least 80 hours per month.... The hype (both positive and negative) about this provision is simply not warranted. Taxpayers will save about $30 billion per year from the enactment of Medicaid work requirements, and about $100 billion per year once other Medicaid provisions of the bill (e.g., more frequent eligibility checks, curtailing state-directed payments) are taken into account. That still leaves about 90 percent of the pricey program untouched at a time of nearly $2 trillion annual deficits and a national debt of $37 trillion.”
Additional reform ideas “would not only provide more significant savings for taxpayers but also give beneficiaries better coverage. A far better approach would be a means-tested, refundable tax credit of approximately $550 per month for individuals to go out and purchase the private healthcare plan of their choice. This would allow households to purchase mid-tier ‘silver’ health insurance plans (which typically cost less than $550 monthly in low-income states such as Mississippi). Assuming a beneficiary population base of 75 million, this would save taxpayers $300 billion per year. Even if Congress used half of those annual savings to reimburse miscellaneous expenses (e.g., high co-pays, out-of-pocket medication costs), taxpayers would still save $150 billion annually on top of OBBBA savings.”
Not all proposals to reduce government healthcare spending survive closer scrutiny. The 2022 Inflation Reduction Act introduced Medicare drug price “negotiations,” which are little more than government-dictated price controls. As American Action Forum President Douglas Holtz-Eakin notes, “The law’s provision with the broadest – and most troubling – implications for future economic policy is perhaps its process of setting the maximum fair price (MFP) for drugs covered by Medicare. The MFPs delivered by this process are government-mandated price controls, backed by the threat of extremely punitive excise taxes on drug manufacturers – although the public is likely to perceive them as voluntary pricing arrangements. ... Price controls are damaging and short-sighted, and an anathema in a market-driven economy. Lawmakers, however, are regularly tempted to overlook their manifest flaws in the pursuit of short-run political favor. The MFP process is likely to have pronounced implications for future economic policy by making price controls more palatable to the public and thus may see more widespread use as a policy tool.” The artificially low prices resulting from this process will make it all-but-impossible for drug makers to recoup development costs, leading to fewer products being made available to consumers. On average, developing a single drug requires hundreds of millions of dollars and many years of research and clinical trials. Additionally, overly restrictive therapy approval policies pushed by public officials such as the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy (RFK) Jr. and Food and Drug Administration (FDA) Commissioner Marty Makary do not help matters. Patients are left wondering whether they’ll be able to access promising treatments such as Elevidys (a gene therapy for a rare movement-related genetic disorder called Duchenne muscular dystrophy). Hopefully, TPA’s new campaign to hold these officials accountable will lead to a fairer, faster, and cheaper process.
If lawmakers want to enact real savings for taxpayers and make the healthcare system far better for consumers, they’ll ditch costly price controls, commit to comprehensive Medicaid reforms, and push the FDA and HHS to reform approval processes.
BLOGS:
Monday: What You Should Be Reading: July 2025
Tuesday: Consumer Watchdog Unveils Campaign Targeting Secretary Kennedy’s Controversial Health Policies
Thursday: The 340B PATIENTS Act Fails Patients and Taxpayers
Friday: Summer Reading: Healthcare
MEDIA:
July 31, 2025: WBFF Fox45 (Baltimore, Md.) interviewed me about Maryland’s Department of Environment lease and remodel of a building.
August 1, 2025: The Baltimore Sun (Baltimore, Md.) mentioned TPA in their story, “Baltimore County IG nominee criticized for 220-mile commute.”
August 1, 2025: WBFF Fox45 (Baltimore, Md.) mentioned TPA in their story, “20-year lease for Maryland's Environment Department raises concerns over unnecessary costs”
August 1, 2025: News Channel 8 WJLA (Washington, D.C.) mentioned TPA in their story about Maryland’s Department of Environment lease and remodel of a building.
August 1, 2025: Townhall ran TPA’s op-ed, “The UK Goes All-In on Online Censorship."
August 2, 2025: RealClearMarkets ran TPA's op-ed, “Asking the Supreme Court to Reject a "Show Your Papers" Internet.”
August 3, 2025: WBFF Fox45 (Baltimore, Md.) interviewed me for a story on the Baltimore Inspector General selection process.
August 3, 2025: Mindanao Daily (Philippines) ran TPA's op-ed, “Consumer Advocates Say WHO ‘Sin Tax’ Plan Will Harm the Poor.”
August 3, 2025: Business Week Mindanao ran TPA's op-ed, “Consumer Advocates Say WHO ‘Sin Tax’ Plan Will Harm the Poor.”
August 3, 2025: Sun Star Network ran TPA's op-ed, “Consumer advocates push back against WHO’s 'regressive' tax plan.”
August 3, 2025: Business Week National ran TPA's op-ed, “Consumer advocates push back against WHO’s 'regressive' tax plan.”
August 4, 2025: WBFF Fox45 (Baltimore, Md.) mentioned TPA in their story, “Baltimore County Inspector General releases annual report hours before vote.”
August 4, 2025: WBFF Fox45 (Baltimore, Md.) mentioned TPA in their story, “Khadija Walker not approved as Baltimore County Inspector General after vote.”
August 4, 2025: Townhall ran TPA’s op-ed, “Shadowy Insurance Bureaucracy Makes Its Own Rules on Customers’ Dime"
August 4, 2025: WBFF Fox45 (Baltimore, Md.) interviewed me for their story on the Baltimore Register of Wills spending.
August 4, 2025: The Texas Tribune ran TPA's op-ed, "Texas Should Lead on Hemp-Based THC Regulation."
August 4, 2025: WCBM (Baltimore, Md.) mentioned me in their story on the recent audit of Gov. Moore’s budget savings claims.
August 4, 2025: WCBM radio (Baltimore, Md.) mentioned TPA in their news segment on the recent audit of Gov. Moore’s budget savings claims.
August 5, 2025: American Banker ran TPA’s op-ed, “Raising deposit insurance limits would cost consumers over $30 billion"
August 6, 2025: The Baltimore Sun (Baltimore, Md.) mentioned TPA in their story, “Audit raises questions over Gov. Moore's $400M budget savings claim.”
August 6, 2025: WBFF Fox45 (Baltimore, Md.) mentioned TPA in their story, “Tax dollars ultimately paying for $100K settlement for University of Maryland.”
August 7, 2025: WCBM radio (Baltimore, Md.) interview me for their news segment on government rebates.
August 7, 2025: WBFF Fox45 (Baltimore, Md.) interviewed me about tariffs and rebate checks.
August 7, 2025: I appeared on WBOB 600AM (Jacksonville, Fla.) to talk about tariffs and the economy.
Have a great weekend!
David Williams
President
Taxpayers Protection Alliance
1101 14th Street, NW
Suite 500
Washington, D.C.
Office: (202) 930-1716
Mobile: (202) 258-6527
www.protectingtaxpayers.org
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