Money, Fees and the Revolving Door

The figure covers the drug review program, the part of FDA that evaluates new drug and biologics license applications. It does not describe the agency's whole budget. Within that program, the share paid by industry rose from 73 percent in 2020 to 77 percent in 2024. Fees and appropriations together supported 5,001 full-time-equivalent staff in 2024.

FDA is right on the narrow point that the fees are pooled and do not buy a particular decision. The program that reviews industry's products is funded mainly by industry, and Congress must reauthorize the fees every five years.

In a 2022 report the Inspector General found that more than one-third of accelerated approval applications with incomplete confirmatory trials had passed their planned completion dates, four of them by more than five years. Medicare and Medicaid spent more than $18 billion from 2018 to 2021 on accelerated approval drugs whose confirmatory trials were overdue. The figure is total spending on those drugs over the four years; it does not isolate spending after a deadline passed or establish that the drugs failed.

A 2024 study in JAMA followed 46 cancer drug–indication pairs granted accelerated approval between 2013 and 2017 for more than five years. The results are set out below.

In January 2025 the Inspector General reviewed 24 accelerated approvals. Ten were chosen because stakeholders had called them concerning and fourteen were drawn at random, so the result is not a failure rate. The review found concerns in three. For aducanumab, an Alzheimer's drug, and eteplirsen, for Duchenne muscular dystrophy, FDA evaluated analyses outside the sponsor's original plan. FDA approved all three drugs despite concerns from its own reviewers or advisory committees. The Inspector General stated that its review was not a compliance review and did not assess whether FDA's decisions were appropriate.

The three drugs followed different courses. Aducanumab's sponsor stopped sales and ended its confirmatory trial in 2024. Hydroxyprogesterone caproate, approved in 2011 to reduce the risk of preterm birth, failed its confirmatory trial in 2019, and FDA withdrew its approval in April 2023 after a two-year wait for a hearing. Eteplirsen was approved in 2016. Its confirmatory trial, due in 2021, had produced no evidence of clinical effectiveness after eight years. FDA then granted accelerated approval to three similar drugs on the same surrogate marker. The clinical reviewer for one of them concluded that the evidence did not clearly meet the standard, but felt bound by the earlier approvals.

The Inspector General recommended that FDA define when its accelerated approval council must advise on an application, and that it document its meetings with sponsors. FDA agreed to the second recommendation and declined the first. When the recommendations were closed on 18 May 2026, the documentation recommendation was recorded as implemented and the council recommendation as not implemented. Congress gave FDA authority in 2023 to require that confirmatory trials be underway before approval or within a set period after it.

The Office of Vaccines Research and Review is one office within CBER; Kaslow does not head the center. CBER is the FDA center responsible for the 2026 vaccine decisions described in Chapter 3 (Finding 3.9).

The United Soybean Board runs the soybean checkoff under the Soybean Promotion, Research and Consumer Information Act. It is governed by farmer-directors, overseen by USDA's Agricultural Marketing Service, and funds soybean promotion and research. Knupp remained a federal employee until early September 2026 and, according to the board, recused herself from soybean matters until she took up the post. Calley Means has described the board as a glyphosate lobbying group (Finding 6.9); that description does not match its statutory role.

Bayer, through Monsanto, is the only domestic producer of glyphosate-based herbicides. In December 2025 the Justice Department reversed its position on Roundup preemption. In 2026 the President conferred Defense Production Act immunity on glyphosate production, and the Supreme Court held Roundup cancer-warning claims preempted (Findings 5.5 and 5.7). Calley Means cited Ballard's revenue in his account of lobbying influence on the White House (Finding 6.9). Lobbying disclosures report amounts and issues, and they do not record which contacts preceded which decisions.

The New Lede reported that several sections of the strategy adopted policy language sought by CropLife America, the pesticide industry's trade association. Its report quotes critics including Moms Across America, the Center for Food Safety and U.S. PIRG. Another report in the record states that the American Soybean Association and CropLife praised the strategy.

The EPA review procedures the strategy cites had produced no valid cancer evaluation of glyphosate since the Ninth Circuit vacated EPA's 2020 decision in 2022 (Finding 5.6). The May assessment had its own defects of record. Undark, reporting NOTUS's findings, stated that seven of the more than 500 studies and other sources it cited did not exist and that dozens more citations had more mundane errors. A later version replaced the fabricated citations, five with different references and two with real studies by the same authors.

In October more than 80 nutrition researchers urged its release. The nutrition scientist Dariush Mozaffarian attributed the delay to industry pressure, which the industry disputes. Trade press and a law-firm alert report that HHS and FDA sent the definition to the Office of Management and Budget as a white paper in August 2026; Food and Agriculture Finding 1.13 records those reports and their limits. Only the Inquirer reports a cancellation; STAT reports that the definition remained unreleased. STAT describes Calley Means as a top MAHA adviser and a driving force behind many MAHA policy efforts. He resigned on 22 October 2026 with a statement that gave no reason. STAT attributes to POLITICO's reporting the account that the stalled definition was behind his departure.

FDA gave its reason in the guidance: "FDA lacks the resources to pursue enforcement against every product that has not received authorization." Products with features that appeal to children, or with greater safety concerns, remain enforcement priorities. The plaintiffs argue that the guidance permits the marketing of products the Tobacco Control Act prohibits and was issued in violation of the Administrative Procedure Act. Calley Means has said that approval of flavored vapes was a top priority for a senior White House official; that is his testimony, and the official disputes his account (Finding 6.9).

Both came before the May enforcement guidance. Politics, Chapter 5 sets the dates beside the filings of a manufacturer's affiliate and its lobbying firm.

The New York Times reported on 28 October 2026 that DEA had backed down after lobbying by the kratom industry. The American Kratom Association disputes that account and has demanded a correction. Calley Means said the tolerance was raised twentyfold; on a solids basis the change was twofold. The regulators were DEA, which schedules controlled substances, and HHS, which supplies the scientific and medical evaluation.

Wiles's office and other officials have responded. According to Axios, a spokesperson for Wiles called the accusations "outrageous, defamatory, and provably false." James Blair disputed the account. Attorney General Todd Blanche called Means a "disgruntled former administration official." Means asked Wiles, Blair and two lobbying firms to preserve their records, and the incoming chair of the House Oversight Committee, Robert Garcia, said he would examine the claims.

Parts of the account match the public record documented in this chapter and in Chapter 5: the executive order on glyphosate, the Justice Department brief in Durnell, the stalled food definition, the vape guidance and the kratom threshold change. The twentyfold kratom figure and the description of the soybean checkoff are overstated. Means has his own disputed interest. Senator Adam Schiff and Representative Jake Auchincloss wrote in 2025 that Means had financial interests in TrueMed, an HSA/FSA reimbursement company, while advising HHS, and asked HHS for any written waiver or recusal memorandum under 18 U.S.C. 208(b).

The drug review program is paid for mainly by the companies it reviews, and their share rose from 73 percent in 2020 to 77 percent in 2024. The accelerated approval pathway permits sale before benefit is confirmed, and the Inspector General has recorded confirmations delayed by years while public insurers paid. Officials have moved from a vaccine maker's research division into FDA's vaccine review office and from the National Security Council into the soybean checkoff.

Between September 2025 and October 2026, four federal health measures were narrowed or delayed. The MAHA strategy dropped the herbicides its own assessment had named. The ultra-processed food definition was not released, and the Inquirer reported that its planned August release was cancelled. FDA deprioritized enforcement against unauthorized vapes. DEA proposed to double its 7-OH threshold for solid products. The herbicide, food and kratom changes followed reported industry lobbying; for the vape guidance, the account of White House pressure is Means's testimony. No document in this record shows a fee or a lobbying payment buying a specific decision, and the industries involved dispute that pressure caused the changes.