The Claim

Approved 67 new drugs, surpassing both the five-year and 20-year averages.

The Claim, Unpacked

What is literally being asserted?

That the FDA approved 67 “new drugs” in calendar year 2025, and that this figure exceeds both the five-year rolling average and the 20-year rolling average of annual drug approvals.

What is being implied but not asserted?

That the Trump administration’s policies — or its approach to FDA regulation — produced a surge in drug approvals. The placement of this item under “MAKING AMERICA HEALTHY AGAIN” implies that RFK Jr.’s HHS leadership and the administration’s regulatory philosophy accelerated drug approvals beyond historical norms.

What is conspicuously absent?

The definition of “new drugs” used to reach 67. Any acknowledgment that drug development pipelines span 10-15 years, meaning every drug approved in 2025 entered clinical trials years before Trump’s second term. Any mention that FDA career staff — not political appointees — review and approve drugs. Any acknowledgment that the administration fired approximately 3,500 FDA employees in April 2025, a move widely expected to slow future approvals.

Evidence Assessment

Established Facts

The FDA’s Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025 — not 67. ¹ CDER’s 15th Annual New Drug Therapy Approvals Report records 46 new drugs never before approved or marketed in the United States, comprising 34 new molecular entities (NMEs) and 12 biologics. This is the standard measure of “new drug approvals” used by the pharmaceutical industry, regulatory analysts, and the FDA itself. Multiple independent sources — RAPS, Chemical & Engineering News, the Society of Chemical Industry, and a peer-reviewed PMC analysis — all confirm the count of 46.

Adding CBER approvals brings the combined total to approximately 55, still well short of 67. ² The FDA’s Center for Biologics Evaluation and Research (CBER) approved 9 Biologics License Applications in 2025, bringing the cross-center total to approximately 55 novel drugs and biologics. An Endpoints News analysis counted 53 novel drugs and biologics agency-wide. Neither figure approaches 67.

Even adding all CDER biosimilar approvals (18) to the 46 novel drugs yields only 64 — still not 67. ³ CDER approved 18 biosimilars in 2025. Adding these to the 46 novel drugs gives 64. Adding the 9 CBER biologics to 46 CDER novel drugs plus 18 biosimilars gives 73. No standard combination of FDA approval categories produces exactly 67. The White House appears to have used a non-standard counting methodology that cannot be reconstructed from official FDA data.

The 46 novel drug approvals in 2025 did not surpass the five-year average; they fell slightly below it. ⁴ The five-year average of CDER novel drug approvals (2021-2025) is approximately 47.6 per year: 50 (2021) + 37 (2022) + 55 (2023) + 50 (2024) + 46 (2025) = 238 / 5 = 47.6. The 2025 figure of 46 is below this average. Looking at the prior five years (2020-2024): 53 + 50 + 37 + 55 + 50 = 245 / 5 = 49.0 — also above 46.

The 46 novel drug approvals in 2025 did surpass the 20-year average, but so has nearly every recent year. ⁵ The 20-year average of CDER novel drug approvals is approximately 36-40 per year, depending on the exact window. The 2025 count of 46 exceeds this, but this is unremarkable: every year since 2017 (except 2022 at 37) has surpassed the 20-year average. The 20-year average is pulled down by the low-approval era of the mid-2000s (roughly 20-25 per year), making it an easy benchmark for any recent year to beat.

Drug development takes 10-15 years from discovery to approval. ⁶ The average drug spends approximately 12-15 years in development, with clinical trials alone averaging 9.1 years according to a peer-reviewed analysis. Every drug approved in 2025 entered its development pipeline years — often a decade or more — before January 2025. The approval decisions reflect the work of FDA career scientists using established review processes, not political direction from the White House.

Strong Inferences

The administration’s actions in 2025 are more likely to reduce future approvals than to have increased them. ⁷ HHS terminated approximately 3,500 FDA employees on April 1, 2025. CDER lost 746 staff in Q4 of FY2025 alone. While drug reviewers were largely spared from direct layoffs, the loss of project management and support staff has disrupted correspondence, guidance development, and application processing. Industry observers and former FDA officials have warned that these cuts will slow future drug reviews and make approval timelines less predictable.

The 67 figure likely includes some combination of novel drugs, biosimilars, and possibly CBER products, but the exact methodology is unclear. ⁸ The closest standard combinations are: CDER novel (46) + CDER biosimilars (18) = 64; or CDER novel (46) + CBER biologics (9) = 55. Adding all three categories yields 73. None produce exactly 67, suggesting either a counting error, a non-standard methodology, or the inclusion of some selective subset of supplement approvals.

What the Evidence Shows

The central numerical claim — 67 new drugs — does not match any official FDA data. The standard measure is CDER novel drug approvals, which totaled 46 in 2025. No standard combination of FDA approval categories produces 67. The White House either used a non-standard counting methodology it has not disclosed, or the number is simply wrong.

Even setting aside the inflated figure, the framing is misleading on multiple levels. The 2025 approval count (46 novel drugs) did not surpass the five-year average; it fell slightly below it. It did surpass the 20-year average, but this is a low bar that nearly every recent year has cleared. The long-term trend in drug approvals has been rising since the early 2010s, driven by advances in biomedical science, faster regulatory pathways created under prior administrations (breakthrough therapy designation was established in 2012 under the FDA Safety and Innovation Act), and the growth of precision medicine and rare disease therapies.

The attribution problem is fundamental. Drug approvals are the endpoint of a 10-15 year pipeline. The 46 drugs approved in 2025 entered clinical development under the Obama and early Trump-1 administrations. The sitting president has no meaningful role in individual drug approval decisions — these are made by FDA career scientists based on clinical trial data and statutory standards. If anything, the Trump administration’s 2025 actions — mass layoffs at FDA, elimination of support staff, and RFK Jr.’s proposed elimination of PDUFA user fees (which fund 46% of the FDA budget) — pose risks to the future pace of approvals, not benefits to the current one.

The Bottom Line

The claim that the administration “approved 67 new drugs” is not supported by FDA data. The actual count of novel drug approvals by CDER in 2025 was 46, and no standard combination of FDA approval categories yields 67. The assertion that this total “surpassed both the five-year and 20-year averages” is only partially true: the actual 46 fell slightly below the five-year average of approximately 48, though it did exceed the 20-year average — as has nearly every year in the past decade.

To the extent drug approvals occurred in 2025, they reflect the work of FDA career scientists reviewing drugs that spent a decade or more in development pipelines established long before this administration. The president’s relationship to these approvals is the same as any president’s: essentially none. The administration’s actual 2025 actions regarding the FDA — mass layoffs, leadership turmoil, and proposed funding changes — are more plausibly a threat to future drug approvals than a cause of current ones.

Footnotes

1. FDA CDER, “Novel Drug Approvals for 2025,” https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025; FDA CDER, 15th Annual New Drug Therapy Approvals Report for 2025; RAPS, “CDER approved 46 novel drugs in 2025, half for rare diseases,” January 2026; SCI, “The FDA approved these 46 new drugs in 2025,” January 2026. ↩

2. OncoDaily, “FDA CDER Releases 15th Annual New Drug Therapy Approvals Report for 2025” (noting combined CDER+CBER total of 58); Endpoints News analysis cited in The FDA Group, “FDA Drug Reviews Held Steady in 2025 Despite Historic Staffing Losses” (counting 53 novel drugs and biologics). ↩

3. FDA CDER 2025 Annual Report (18 biosimilars); multiple FDA data sources confirm these category counts. ↩

4. Year-by-year CDER novel drug approval data: 2021 (50), 2022 (37), 2023 (55), 2024 (50), 2025 (46). Sources: FDA Novel Drug Approvals pages for each year; PMC analysis (PMC12898419). ↩

5. Historical CDER data compiled from FDA Novel Drug Approvals pages and PMC, “The Pharmaceutical Industry in 2025” (PMC12898419); FDA Compilation of CDER NME Drug and New Biologic Approvals, 1985-2024. ↩

6. PMC, “Clinical development times for innovative drugs” (PMC9869766); Drugs.com, “FDA Drug Approval Process.” ↩

7. Skadden, “Mass Layoffs at FDA Could Have the Greatest Impact on Products in Development,” April 2025; The FDA Group, “FDA Drug Reviews Held Steady in 2025 Despite Historic Staffing Losses” (noting CDER lost 746 staff in Q4 FY2025). ↩

8. Author’s analysis combining official FDA data from CDER and CBER annual reports. ↩