14. Department of Health and Human Services · Minor
Free NIH, CDC, and FDA regulators from private biopharmaceutical funding
Printed page 452 14. Department of Health and Human Services
“All National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration regulators should be entirely free from private biopharmaceutical funding. … Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”
What has happened
- Not started
FDA moved the other way on the Quote's FDA limb. Its notice opening the reauthorization of the Biosimilar User Fee Act publishes proposed recommendations for BsUFA IV, fiscal years 2028 through 2032, reached after FDA "conducted negotiations with the regulated industry" from April through June 2026. BsUFA "authorizes FDA to assess and collect fees from drug companies that submit marketing applications", and the proposal keeps that arrangement. It modifies review categories, timelines and meeting types, and it adds "financial transparency", but it does not end or phase down the fees. The Quote asks that agency funding "come directly from the government"; the administration's own proposal to Congress is to renew the biopharmaceutical industry's funding of FDA's biosimilar review for five more years. A proposal, not an enactment. It is the agency's stated position, and Congress has not yet acted on it.
- Not started
The CDC limb, read directly at last. CDC's ACIP membership criteria page (`/acip/apply-for-membership/index.html`, read 2026-09-03) carries its own date of 2024-12-20 — it has not been revised since before the evidence window — and its conflict-of-interest regime is the pre-existing one: annual confidential financial disclosure, disclosure called at the opening of every meeting and before every vote, and recusal by members with declared interests. The words "pharmaceutical", "divest" and "cooling-off" do not appear anywhere on it. No industry-funding bar, no divestment requirement and no criterion of any kind was added after the June 2025 removal of all seventeen members. What did happen inside the window is disclosure, not separation: CDC published a new *Conflicts of Interest Disclosures of ACIP Members* web tool on 2025-07-09 listing declarations from 2000–2024. And the reconstituted roster, dated 2026-07-24, shows the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization still holding non-voting liaison seats. Both are dated in-window Primary CDC documents on this ask's object that do not satisfy it — moved nearby, not delivery: ACIP members are outside advisers rather than the NIH/CDC/FDA regulators the Quote names, and nothing here frees any regulator from private biopharmaceutical funding.
- Not started
Congress moved the other way on the Quote's second sentence. The FY2026 Agriculture/FDA appropriation re-enacted industry funding of FDA's drug programs: of the $6,957,972,000 appropriated to FDA, $1,556,039,000 is derived from prescription drug user fees (21 U.S.C. 379h), $670,900,000 from human generic drug user fees (21 U.S.C. 379j-42) and $55,841,000 from biosimilar biological product user fees (21 U.S.C. 379j-52) — roughly $2.28 billion of private money, with collections above the FY2026 limitations appropriated automatically. The Mandate asks that agency funding "come directly from the government"; the enacted appropriation does the opposite for the FDA's biopharmaceutical review.
- Not started
The nearest directive of the window does not reach this ask. EO 14212 establishing the Make America Healthy Again Commission states as policy that all federally funded health research "should avoid or eliminate conflicts of interest that skew outcomes" (§2(a)) and tasks the Commission with "eliminating undue industry influence" (§5(a)(ix)) — but its operative instruction on industry money is to "establish a framework for transparency and ethics review in industry-funded projects" (§5(a)(x)), which assumes industry-funded projects continue. It ends no funding stream, names no agency's funding, and creates no restriction on NIH, CDC or FDA staff. Disclosure and ethics review are not the separation the Quote asks for.
Research log
What was searched, and what didn’t count as evidence
Research notes
- The boundary call. EO 14212 could be read as attempted: it is a government-wide policy directive naming conflicts of interest and industry influence, and the chapter already levels #1216 at attempted on a comparable government-wide order (EO 14182). It is held at not started here because the order’s only operative instruction about industry money is a transparency-and-ethics-review framework, which is disclosure rather than separation, and because the enacted FY2026 appropriation moves the funding question the other way.
- The June 2025 removal of all seventeen ACIP members, and the litigation over it, are the window’s most visible conflict-of-interest action touching CDC. They are not Evidence here: ACIP members are outside advisers, not the NIH/CDC/FDA regulators the Quote names, and the removal imposed no rule about industry funding. The only allowlisted Primary trace found is a passing description in American Academy of Pediatrics v. HHS, D.D.C. 25-cv-4505, memorandum opinion of 2026-01-11 (https://www.courtlistener.com/opinion/10773011/american-academy-of-pediatrics-v-us-department-of-health-and-human/), a grant-termination case that recites “HHS administrative actions to remove all seventeen members of ACIP” as background. Kept as a lead.
- cdc.gov and hhs.gov were recorded as refusing to open through 2026-09-01. Both can be read. CDC’s ACIP membership-criteria, roster and disclosures pages were read on 2026-09-03 and are now in the Status note above.
- HHS’s own standards-of-conduct rulemaking of the window (FR 2025-16129, 45 CFR part 73, published 2025-08-22) is a housekeeping revision — gifts, foreign-government employment, workplace conduct, Public Health Service political activity — and adds nothing about biopharmaceutical funding.
- The companion asks are #1212 (CDC Foundation pharmaceutical money) and #1251 (decommission the CDC and NIH Foundations), both not started.
- BsUFA IV (found 2026-09-27, read on review). FR 2026-19660 was read in full. Its Section III, “Proposed BsUFA IV Recommendations”, keeps fee collection for FY2028-2032 and changes only how the review works, so it is recorded above as a moved-the-other-way event. The prescription-drug (PDUFA) and device (MDUFA) programs expire on the same schedule; their notices, when they publish, would belong on the same event or a later one.
- One search, run 2026-09-01, covered the four p. 452 asks: this one, #1203, #1204 and #1205.
- Action
- restrict
- Object
- private biopharmaceutical funding of NIH, CDC, and FDA regulators
- ID
- 1202