When Congress Handed Big Pharma the FDA’s Strings
Can an agency that answers to the drug industry protect you?
Note: This is the second in a three-part series examining the structural corruption of the FDA and the challenges facing its new commissioner, Dr. Marty Makary. Part 1 examined the influence of industry over FDA advisory committees. Part 2, below, traces how Congress helped cement that influence through legislation like the Prescription Drug User Fee Act (PDUFA), reshaping the FDA into a partner of the pharmaceutical industry. Part 3 will explore the revolving door between FDA leadership and pharma.
Industry Before Public Safety
Regulatory Capture
The tendency of regulators to identify with the interest of the industry they are supposed to regulate. This occurs when a public authority charged with regulating an industry in the public interest comes to identify the public interest with the interests of producers in the industry, rather than the interests of its customers, or the general public. — Oxford Reference
The above definition of regulatory capture aligns with Dr. Makary's stated understanding of how the FDA is intended to collaborate with the pharmaceutical industry and its mission statement, which delineates the agency's subservience to industry interests. It was also enshrined into law by the PDUFA, as Donald Light and co-authors explained in the abstract of their 2013 paper “Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs,” published in the Journal of Law, Medicine and Ethics:
The authorization of user fees has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. (Emphasis added.)
They explain in the paper (p. 595) that the Act, passed at the behest of pharmaceutical companies demanding quicker agency approval for their drugs, required the companies to pay user fees to the FDA in return for which the agency would speed up the approval process and review priority applications within 6 months and regular applications within 12 months. The result: dangerous drugs reached the market with the FDA’s blessing.
An in-depth analysis found that each 10-month reduction in review time — which could take up to 30 months — resulted in an 18.1-percent increase in serious adverse reactions, a 10.9-percent increase in hospitalizations, and a 7.2-percent increase in deaths.
Agency staffers found themselves under significant stress: shorter deadlines meant less time to review drugs, since a missed deadline could lead to reductions in PDUFA funding. Consequently, drugs approved within two months of the deadline had 3.27 times more black box warnings than drugs approved at other times (i.e., without the pressure of coming up to the deadline) and a 6.92 times greater likelihood that the drug would be withdrawn because of serious adverse events. Furthermore, concerns arising at the end of the review period were not adequately addressed. As a result, tens of thousands of additional people were hospitalized, had adverse reactions, and died.
Studies have shown, as reported by Marina Zhang in a 2022 Epoch Times article, “94 Percent of Medication Not Supported by High-Quality Evidence, Harms Underreported: Study,” that of 1,567 drugs reviewed during the period 2008-2021, 94% lacked high-quality evidence of their benefits, while harms were underreported. During the period 1983-2018 (even before the PDUFA was enacted), the FDA was approving more drugs with less rigorous testing, shortened review periods, and with substantial harms.
What Regulatory Capture Looks Like in Practice
The FDA had already been inclined to serve industry. The PDUFA formalized and deepened that allegiance.
Pharma Dictates the Terms
As part of the PDUFA, Congress required the FDA to negotiate the terms of the agreement with the pharmaceutical companies. Since the PDUFA expires every five years, the FDA is forced to keep renegotiating the terms each time. Currently, the drug industry provides the FDA with 75-80% of its budget for scientific reviews. creating a dangerous conflict of interests.
An investigative report, “Drug Money: FDA Depends on Industry Funding; Money Comes with “Strings Attached,” by David S. Hilzenrath for the watchdog organization Project On Government Oversight (POGO), looks at how the PDUFA has enabled Big Pharma to dictate to the FDA, rather than the other way around. He wrote about PDUFA renewal negotiations for the period from September 2015 to January 2016. Closed to the public, the negotiations included teams of FDA officials in 70 meetings with drug company executives and lobbyists in order to set goals that favored industry.
… [The negotiations] also entailed an extensive review and rethinking of how the FDA does its job. Tentatively, it has set the FDA on a course to increasingly look beyond data from controlled clinical trials—the costly mainstay of medical research—when assessing drugs. In the commitment letter, in buzzwords that track industry’s wish list, the FDA has pledged to pursue the use of “patient-reported outcomes” and “real-world evidence.” The agency also promised to explore “novel clinical trial designs,” including “highly innovative” ones for which “simulations are necessary.” (Emphasis added.)
The meetings served to weaken the FDA’s regulatory abilities and corrupt the science.
Unless “real-world evidence” follows principles of well-designed clinical trials, such as comparing the experimental drug to a placebo and committing to a study design before observing the results, “it should be regarded as simply a deregulatory exercise and a departure from rigorous science,” Harvard’s [Daniel] Carpenter [a professor of government who has published work on the FDA and on “regulatory capture”] said by email. (Emphasis added.)
FDA Prioritizes Industry Over Public Safety
In her 2018 ProPublica report, Chen gave examples of the horrific results when the FDA rushes approval for drugs. The agency approved Nuplazid and Uloric, despite both being more dangerous and deadly than the standard of care or no treatment. Both had failed two out of three clinical trials.
… Uloric’s manufacturer reported last November that patients on the drug were 34 percent more likely to die from heart disease than people taking an alternative gout medication. And since the FDA fast-tracked approval of Nuplazid and it went on the market in 2016 at a price of $24,000 a year, there have been 6,800 reports of adverse events for patients on the drug, including 887 deaths as of this past March 31.
The agency seems to have abandoned the public.
The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease.
This has resulted in more and more unsafe and unproven drugs getting the FDA’s stamp of approval.
The FDA okayed 46 “novel” drugs — whose chemical structure hadn’t been previously approved — in 2017, the most in at least 15 years. At the same time, it’s rejecting fewer medications…
Furthermore, Chen explained, the FDA approves drugs that have not been shown to enhance survival in return for manufacturers agreeing to conduct the research after the drugs are marketed to the public.
The FDA also increasingly allows drugmakers to claim success in trials based on proxy measurements — such as shrunken tumors — instead of clinical outcomes like survival rates or cures, which take more time to evaluate. In return for accelerated approval, drug companies commit to researching how well their drugs work after going on the market.
Are drug companies saving money on drug trials by making the public unwitting and unconsenting trial participants?
Even the former chair of the FDA’s opioid drug review committee, Dr. Raeford Brown, has spoken out. Quoted in the article “Top FDA Official Blows Whistle as Agency Approves Drug 10X Worse Than Fentanyl, Funded by DoD,” by Matt Agorist at The Free Thought Project, Brown said he lost faith in the FDA’s ability to protect the public after more than 25 years of watching it approve increasingly dangerous opioid drugs. Brown accused the agency of serving Big Pharma interests over public safety and described its loyalty to the drug industry as “potentially criminal.”
Listen to Russell Brand read and comment (below) on an article by C. Michael White, Distinguished Professor and Head of the Department of Pharmacy Practice at the University of Connecticut, titled “Why is the FDA funded in part by the companies it regulates?”, published in The Conversation.
Don’t have the FDA funded by the people it’s regulating. Ban lobbying — right now, immediately…
We say it can’t be improved because we’d prefer you didn’t improve it. It’s perfectly good for us the way it is, because we can all make loads of money from it — even if it causes tremendous, unimaginable suffering for ordinary people. That is, in fact, irrelevant.
FDA Leadership Promotes Industry Interests
Exemptions/Waivers
FDA policies don’t just allow for industry influence; they’re structured to manage it in ways that prioritize inclusion over independence. A case in point is a 10-page FDA PowerPoint titled "FDA Advisory Committees: Financial Conflicts of Interest Overview," which outlines how advisory committee conflicts are officially handled.
Before each meeting, members known as Special Government Employees (SGEs) must disclose financial interests such as consulting fees, grants, stock holdings, or leadership roles in companies that could be affected by the committee’s decisions.
This includes not only the company sponsoring the drug under review but also competing companies whose products might be impacted. The FDA reviews these disclosures, but disclosure alone doesn’t disqualify someone. The agency can issue waivers if it deems the person’s expertise more valuable than the risk of bias, or decide that the conflict is too minor to matter.
The solution the FDA utilizes to prevent conflicts of interest is thus to rely solely on the SGEs to keep track of and report their conflicts and then to consider not acting on those conflicts!
In short, the FDA doesn’t eliminate conflicts of interest. It manages them.
Additional Evidence of Institutional Capture
Institute of Medicine Warned of Industry Dependence
A 2006 assessment of the FDA by the Institute of Medicine, at the FDA’s request, included the following:
[The PDUFA] has had some drawbacks, including increasing the agency’s dependence on industry funding for its drug review activities, severely skewing CDER’s [Center for Drug Evaluation and Research’s] focus to facilitating review and approval perhaps at the expense of other center activities, and creating an environment of intense pressure on its reviewers.
DA Official: “Industry Is Our Client”
Hilzenrath's investigative report confirmed that the FDA views industry as its client:
The culture of the FDA “views the pharmaceutical industry it is supposed to regulate as its client. It overvalues the benefits of the drugs it approves, and it seriously undervalues, disregards and disrespects drug safety,” [FDA safety official David] Graham said at the 2004 Senate hearing.
Drug Approval Based on Financial Concerns
The drug manufacturer’s stock price and financial position were the main considerations in the approval of Sarepta, a drug being trialed for Duchenne Muscular Dystrophy. This occurred even though its case for approval was weak, according to [Dr. Ellis] Unger, director of an FDA drug evaluation office.
“The approval of this NDA”—new drug application—“in its present form would have far reaching negative consequences for the public health,” he wrote in a July memo. Unger was overruled by [Janet} Woodcock [head of the CDER]. He appealed to an internal FDA board responsible for resolving scientific disputes. In a presentation to the board, Woodcock talked about the drug maker’s financial condition and stock price. “Dr. Woodcock cautioned that, if Sarepta did not receive accelerated approval for eteplirsen, it would have insufficient funding to continue to study eteplirsen and the other similar drugs in its pipeline,” Luciana Borio, the FDA’s acting chief scientist, wrote in an account of the appeal. Woodcock also “emphasized her view that the agency needs to accept more uncertainty when granting accelerated approval,” Borio wrote. (Emphasis added.)
Promotion Tied to Industry Loyalty
From Chen's report:
“You don’t survive as a senior official at the FDA unless you’re pro-industry,” said Dr. Thomas Marciniak. A former FDA medical team leader, and a longtime outspoken critic of how drug companies handle clinical trials, Marciniak retired in 2014. “The FDA has to pay attention to what Congress tells them to do, and the industry will lobby to get somebody else in there if they don’t like you.”
Staffers know “you don’t get promoted unless you’re pro-industry,” he added.
Resignation Highlights Corruption of Approval Process
A letter written to the FDA in October 2021, by Michael T. Abrams for the Public Citizen’s Health Research Group, regarding the upcoming renewal of the PDUFA included the following:
Resignation over Corrupt Approval Practices
… Aaron Kesselheim M.D., J.D., M.P.H., Director of the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School, resigned from the Peripheral and Central Nervous System Advisory Committee because of the FDA’s decision to approve aducanumab (Aduhelm) for treatment of Alzheimer’s disease in direct opposition to the nearly unanimous opinion of that expert advisory committee. In his resignation letter to Acting FDA Commissioner Janet Woodcock, Dr. Kesselheim wrote: “FDA is not presently capable of adequately integrating the Committee’s scientific recommendations into its approval decisions.” (pp 1-2)
Fast-Tracked Drugs, Reduced Safety
… research that shows that 81% of NDA [New Drug Application] approvals in 2018 involved Accelerated Approval, Fast-Track, or Priority Review and that faster approvals under PDUFA correlated with the marketing of products that were less safe than those marketed before the PDUFA was instituted.
Faster approvals correlate with less safety
… interactive communications established under PDUFA have resulted in inappropriately close collaborations between the Agency and sponsors that have compromised the integrity for NDA/BLA [biologics license applications] reviews. (p4)
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This deep culture of collusion didn’t happen by accident. In Part 3, we’ll look at how the revolving door between FDA leadership and the drug industry turned regulatory oversight into career leverage, and how that impacts the safety of the drugs Americans rely on.