The Birth of FDA Pay-to-Play

The cozy relationship between Big Pharma and the FDA began in earnest in 1992 with the passage of the Prescription Drug User Fee Act. President Ronald Reagan’s White House viewed regulatory agencies not as caretakers of the public interest, but rather as teammates of industry. As then vice president George H.W. Bush put it, “Government shouldn’t be an adversary [of industry]. It ought to be a partner.”

At the time, the FDA was hardly a partner of industry or patients. Companies could submit the results of clinical trials only to wait years to find out if their drugs were approved — a delay that could cost them millions of dollars in lost revenue, while patients’ health and lives hung in the balance. Along with companies, a few patient advocacy groups, particularly members of the AIDS community, were clamoring for faster approvals. But while public ire was directed at a sluggish FDA, it was the Reagan Administration and Congress that were refusing to appropriate the money the agency needed to hire more staff.

Drugmakers, together with patient activists, began pushing for passage of the Prescription Drug User Fee Act, which would require drug companies to pay user fees to the FDA to beef up its budget. In return, the agency agreed to put the money toward drug approvals, not post-market safety monitoring, and to complete its reviews of drug applications within twelve months.

David Kessler, then the FDA commissioner and a supporter of the legislation, promised Congress the funding scheme would not threaten the agency’s independence. He told the New York Times in 1992, “I am not talking about lowering standards. Or jeopardizing the integrity of product review. I am simply talking about getting the resources we need to keep pace.” By 2001, the agency was able to hire nearly one thousand additional drug reviewers and computerize its systems, slashing review times to fourteen months.

Contrary to Kessler’s assurances, the Prescription Drug User Fee Act has indeed led to lower scientific standards in the name of speedy approvals. Because the bill must be reauthorized every five years, the pharmaceutical industry has had repeated opportunities to lobby Congress and the FDA for ever more concessions, further weakening the agency’s scientific standards and increasing its sense of loyalty to the companies it regulates.

“It’s hard to overstate the value of [the Prescription Drug User Fee Act] for the drug industry,” says legal scholar Aaron, who spent two years at the FDA after medical school.

One FDA drug safety reviewer said in congressional testimony, “FDA culture regards industry as the agency’s primary client rather than an entity in need of regulation.” According to a former FDA reviewer, who asked to remain anonymous for fear of retribution, agency managers are afraid to be seen as an impediment to medical progress, and to risk the ire of their pharmaceutical company “partners.”

That’s one reason pharmaceutical interests lobby hard in the run-up to every reauthorization of the act. In 2024, pharmaceutical manufacturers deployed 738 lobbyists — nearly a lobbyist and a half for every member of Congress. It spent more than $151 million on lobbying, more than any other industry, including oil, banking, and tech, according to OpenSecrets, a nonprofit watchdog group that monitors political contributions and spending.

Thanks to the Prescription Drug User Fee Act, drugmakers also get special access to the FDA. The agency is required to meet with both industry and public stakeholders as it hammers out details of the updated bill, says Reshma Ramachandran, a physician and a codirector of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency. But she says that regulators spend far more time with pharmaceutical representatives than medical experts.

“They met with us six times,” said Ramachandran of the last reauthorization effort. “They met with pharma 150 times. If you actually track what pharma says it wants at the beginning of the negotiations over [the Prescription Drug User Fee Act] and what FDA actually commits to, it very much reflects those sorts of priorities that industry has laid out. By the time public stakeholders are able to weigh in, it’s at the end of the process when FDA has already negotiated everything with industry.”

The FDA did not respond to multiple requests for comment on the matter.

The passage of the Prescription Drug User Fee Act did more than open a door to regulatory capture. It also alerted industry to the power of a potential new ally — one that few would expect.

When Patients Are Paid to Cheer

In 2016, Kim Witczak was sitting in an FDA meeting room in Silver Spring, Maryland, listening to testimony from the families of patients with Parkinson’s disease. A marketing executive and drug safety activist from Minneapolis, Witczak was a consumer representative on the FDA’s drug advisory committee reviewing Nuplazid, a new medication to treat a devastating condition known as Parkinson’s psychosis.

During the public portion of the meeting, patients and family members stepped up to a microphone one by one to tell their stories of the hallucinations, delusions, and personality changes — and to plead for the drug’s approval.

The only problem, Witczak told the Lever, was that Nuplazid did not work very well, if at all. In three separate clinical trials, Acadia Pharmaceuticals, the manufacturer, had failed to show its drug was any better than a placebo. The company then ran a fourth trial using a modified version of the standard twenty-question test for symptoms. Only this time, the test included just the questions that had shown “the most favorable change” in the previous trials. According to this measure, Nuplazid appeared to be effective.

Then there was the problem of deaths. Treated patients were three times as likely to die as patients given a placebo. The company noted in its submission to the FDA that study investigators concluded that most deaths were “unrelated or unlikely connected with the study drug.” Patients on the treatment were also more prone to other serious complications, including psychiatric symptoms. Paul Andreason, the FDA scientist in charge of reviewing Nuplazid, recommended against approval, citing the drug’s questionable clinical trials, its “minimal clinical benefit,” and its “unapprovable safety profile.”

Acadia did not respond to multiple requests for comment.

After the public testimony, Witczak recalls that most of her fellow committee members were more interested in expressing their sympathy for patients than in considering the drug’s flimsy efficacy data and poor safety record.

“They said, ‘This is a serious disease. We need to have options for these patients and their doctor,’” she told the Lever, “As a human being, of course you’re drawn to the emotional. But our job was to look at the science as well as how much need there was.”

Witczak voted against approving Nuplazid, along with only one other committee member (who had Parkinson’s disease). The remaining twelve voted in favor of the drug. When Andreason’s supervisor overruled him and the FDA approved Nuplazid a month later, Parkinson’s advocacy groups cheered the decision. Michael Okun, national medical director of the Parkinson’s Foundation, told the newsletter Parkinson’s News Today, “The approval of Nuplazid represents a major paradigm shift in the treatment of Parkinson’s disease psychosis.”

What Nuplazid’s approval really represented was the power of pharmaceutical money to use patient advocates as proxies, says Adriane Fugh-Berman, a physician and professor of pharmacology and physiology at Georgetown University School of Medicine.

“Some public testimony at FDA hearings is staged and manipulated by industry,” she says. “Drug companies want advisory committees to listen to the emotions and not look at the science.”

An examination of financial disclosure forms filed with the FDA revealed that most patients and family members at the hearing had their travel and lodging expenses covered by either Acadia or a patient advocacy group that received funding from drugmakers. The Parkinson’s Foundation, along with other major advocacy groups in favor of approving Nuplazid, including the Michael J. Fox Foundation for Parkinson’s Research, receives funding from Acadia and other drug companies.

Absent from the meeting were the accounts of patients who died while taking Nuplazid or were too incapacitated from the drug to share their story, as well as the vast majority of patients who likely never knew the meeting was happening. The only way many patients learn of such FDA meetings is through drug companies, which are incentivized to tap only patients who’ve had successful outcomes.

Advocacy groups can do a great deal of good for their members, providing information to newly diagnosed patients, for example, and compiling data on disease rates and treatments. Drug companies gain insight by talking to advocates about what they need from their medicines. But the amount of money that pharmaceutical companies spend on advocacy groups — a whopping $6 billion to twenty-thousand-plus advocacy organizations between 2010 and 2022 — suggests there’s also a financial incentive for drugmakers.

A database compiled by KFF Health News, using publicly available tax documents, tallied $116 million in donations to patient groups in 2015 from just 14 companies — a figure that dwarfs the $63 million those same drug companies devoted that year to lobbying.

A study led by researchers at the University of Pennsylvania found that 83 percent of the 104 largest patient advocacy groups (those with revenues over $7.5 million a year) make as much as half of their revenue in contributions from the drug industry.

“These companies would not be spending that kind of money and time on their relationships with patient advocacy groups if it didn’t improve their bottom line,” says Sharon Batt, an adjunct professor of bioethics at Dalhousie University in Nova Scotia.

Drug company employees with titles like “director of patient engagement” carefully cultivate relationships with advocacy groups. Some patient groups are led by executives on “loan” from industry, according to a study published in 2020, and nearly 40 percent have a pharmaceutical executive on their boards. Another study, by Patients for Affordable Drugs, the rare advocacy group that does not accept money from pharmaceutical companies, found that twelve of fifteen major patient advocacy organizations have pharmaceutical industry representatives on their boards. All but one of the groups failed to fully disclose the amount of money they receive from the industry.

Companies offer their advocacy partners access to lobbyists and public relations experts to help them with marketing and outreach — operatives who also happen to represent the companies. Meanwhile, industry scientists provide these groups information about their drugs, making patient advocates feel like they have the inside scoop on cutting-edge science — science that many people aren’t equipped to understand or interpret.

A best-practices report by a pharmaceutical consulting company based in North Carolina estimates that drugmakers devote, on average, the equivalent of six full-time positions to nurturing relationships with patient advocates.

Batt, a cancer survivor, patient advocate, and author of a book about breast cancer advocacy and the pharmaceutical industry, says patient advocates eventually begin to internalize industry-crafted messages.

“The companies give them money, they train patients how to testify on behalf of industry, and help them flood the FDA with comments,” she says. “Pretty soon, these groups are championing industry narratives. They argue that patients can decide for themselves what to put in their bodies, that newer drugs are the best drugs, that new drugs are worth it, no matter the cost.”

Fran Visco, president of the National Breast Cancer Coalition, agrees.

“Many patient organizations are only interested in more drugs, not better drugs,” she says. “I was in a science meeting and one of the participants from a patient group said, ‘I’m just trying to get more drugs into patients.’ I said that’s not what we’re interested in. We’re interested in drugs that work.”

The Inbox Revolt

Putting their messages in the mouths of patient organizations is a double win for pharmaceutical companies: These groups serve as covert marketers of their sponsors’ drugs to a public that is largely unaware of their industry funding, so their promotional and lobbying efforts for industry-friendly legislation and drug approvals seem to be coming from an independent and highly credible source.

The power of these advocacy groups can also be weaponized to overwhelm the FDA.

In 2015, for example, patient advocates inundated the agency with 2,792 emails and numerous phone calls demanding the approval of a new Duchenne muscular dystrophy drug, Exondys 51. A rare and tragically fatal genetic disorder, Duchenne afflicts mostly boys, preventing their bodies from making enough dystrophin, a protein that’s necessary to keep muscles working. Most people with Duchenne must use wheelchairs as teenagers and die by age thirty.

The drug’s manufacturer, Sarepta, provided the FDA with data showing that Exondys 51 could help patients produce dystrophin, but only in tiny amounts — and the data came from just twelve patients. The company’s studies also failed to demonstrate that Exondys 51 provided any meaningful improvement in the boys’ ability to walk. Ellis Unger, the FDA scientist in charge of reviewing the drug, shredded Sarepta’s results, writing that accelerated approval for Exondys “would lower the evidentiary standard for effectiveness to an unprecedented nadir.”

But Duchenne advocacy groups leaned hard on the FDA to approve the drug, meeting as many as a dozen times with Janet Woodcock, then director of the Center for Drug Evaluation and Research, and Unger’s boss. Some advocates went further, their petitions verging on threats. According to FDA documents, one advocate wrote to then FDA commissioner Robert Califf, “How is it that everyone in and around Duchenne muscular dystrophy understands this simple idea and the science geniuses at FDA don’t? You stupid f-ckers are costing each and every DMD kid days of their lives with your Moronic Dystrophin dance. Time to get a f-cking clue…”

Besides its patient advocacy champions, Sarepta had friends in high places. Rick Santorum, former Republican senator from Pennsylvania, tweeted that he planned to attend an advisory meeting in support of the drug. After multiple meetings with the company, Woodcock began saying she was inclined toward approval because the company “needed to be capitalized.” A lawsuit filed by an FDA watchdog alleges that a total of 109 members of Congress lobbied the FDA in favor of Exondys 51’s approval, according to court documents reviewed by the Lever. Agency leadership approved the drug in September 2016, even after its advisory committee on the matter gave Exondys 51 a decisive 7–3 thumbs-down.

In a formal complaint to his supervisors, Unger called Exondys 51 “a scientifically elegant placebo.” By allowing the marketing of an ineffective treatment, he wrote, the FDA was giving thousands of patients and their families “false hope.” Even worse, he added, “…false scientific conclusions have the potential to mislead the field of medicine, slowing progress in finding and developing therapies that actually are effective. There could also be significant and unjustified financial costs — if not to patients, to society.”

The drug is now priced from $750,000 to $1.5 million per patient, and contributes to the $1.79 billion Sarepta makes each year from muscular dystrophy drugs.

Sarepta has yet to complete a controlled study showing Exondys 51 helps children with Duchenne muscular dystrophy live longer or even walk a few more steps. In response to questions, the company acknowledged it did not have data from a new clinical trial, but said it has “real-world” evidence of benefit.

After Unger left the FDA in 2021, he began working at a Washington, DC–based law firm advising drug companies on product development.

“No one at FDA gets rewarded for stopping a drug,” says Charles Seife, a professor of journalism at New York University and longtime FDA observer. “Protecting the public from drugs that don’t work is not just not rewarded, it’s punished. You’re seen as a troublemaker. When someone does articulate concerns and the agency requires follow-up studies, it doesn’t follow through. I’ve never seen a bureaucracy refuse to exercise the powers it’s been granted like the FDA.”

Spin Doctors

By the time Robert Califf’s name was floated in 2022 by the Biden administration as a possible candidate for FDA commissioner, trust in the agency had plummeted. Still in the grip of the COVID-19 pandemic, the public had been whipsawed by confusing and ultimately discredited FDA decisions during Trump’s first tenure in the White House. By 2022, a poll found that only 27 percent of the public had a “great deal” of trust in the agency and its decisions.

Califf was sold as the balm a pandemic-weary nation and a dispirited agency needed. He had served as FDA commissioner for eleven months during the Obama Administration before Trump assumed office, and he was an experienced clinical trial researcher who had joint appointments at Stanford and Duke universities. In announcing his nomination, President Joe Biden said, “As the FDA considers many consequential decisions around vaccine approvals and more, it is mission-critical that we have a steady, independent hand to guide the FDA.”

The FDA may have gotten a steady hand in the seventy-year-old cardiologist, but it did not appear to get a fully independent one. According to disclosure documents filed in July 2020, Califf had financial relationships with more than two dozen drug companies. Between his first stint as commissioner and his second, he was paid $2.7 million by Verily Life Sciences, a biomedical research organization operated by Alphabet Inc. (Google’s parent company), and his portfolio included millions of dollars in biotech stock.

During his tenure, Califf presided over a series of questionable drug approvals by the FDA, including Exondys and the new Alzheimer’s drugs, which have been found to provide insignificant benefits with serious and sometimes deadly side effects.

But Califf was not the first high-level FDA official to arrive with a conflict of interest that risked influencing their regulatory decisions.

Daniel Troy was appointed chief counsel at the agency in 2001 by President George W. Bush after previously suing the FDA on behalf of drug and tobacco companies. Once installed, Troy invited lawyers from drug and medical device companies to inform him of pending lawsuits, so his FDA office could aid in their defense. At a legal conference in 2003, he told industry lawyers, “We can’t afford to get involved in every case. . . we have to pick our shots.” To ensure that a plea would get his attention, Troy told lawyers to make their case “sound like a Hollywood pitch.”

The tilt to industry-friendly FDA management began in 1969, even before the passage of the paradigm-shifting Prescription Drug User Fee Act. That year, President Richard Nixon changed the role of FDA commissioner from a lifetime civil servant to a political appointee, opening the door to commissioners who could come from industry with significant financial conflicts of interest.

During the past two decades, seven of the agency’s eight commissioners have had financial ties to pharmaceutical and/or medical device companies. The result? FDA decisions and interpretations of legislation have increasingly benefited drugmakers at the expense of public health.

Take Margaret Hamburg, appointed by President Barack Obama in 2009 and hailed by public health organizations as a reformer who could “fix the FDA.” Hamburg had deep financial conflicts of interest with industry, which went virtually unnoticed in the press.

Hamburg’s husband, Peter Brown, was a principal at Renaissance Technologies (RenTec), a multibillion-dollar hedge fund with large investments in numerous pharmaceutical companies. Before taking the helm at the FDA, Hamburg and Brown sold their stock in a number of the drug companies held by RenTec. But the FDA did not investigate the couple’s investments in RenTec’s exclusive, highly lucrative Medallion Fund, which was also heavily invested in pharmaceutical companies, earning the family at least $3 million between 2009 and 2010.

Hamburg, who did not respond to a request for comment, previously told the BMJ that the Office of Government Ethics reviewed any potential conflicts regarding their investments and did not require additional divestments.

During her tenure, the FDA expedited several drug approvals, despite questionable evidence of their efficacy. In 2012, she shepherded a new “breakthrough pathway” for drug approvals, enabling pharmaceutical companies to secure faster approvals than ever before.

On paper, breakthrough status is intended for new drugs that offer a substantial improvement over existing treatments. However, a four-year review by researchers at Harvard found that the breakthrough designation was awarded based on preliminary data “long before the evidence to substantiate such claims is available.”

Once FDA managers and drug reviewers leave the agency, they often take jobs at the very companies they previously regulated. Vinay Prasad, who is currently the FDA’s Chief Medical and Scientific Officer, told KFF Health News in 2016, “If you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate,” Prasad said. “Are you more likely to give [companies] the benefit of the doubt?”

By 2022, nine of the last ten FDA commissioners went to work for a drug company after leaving the agency. A 2018 review by the journal Science found that eleven of sixteen drug reviewers who left the agency between 2009 and 2018 took industry jobs. Some landed at the companies whose drugs they had recently reviewed.

An investigation by the BMJ found that two FDA reviewers who oversaw the approval of COVID-19 vaccines later departed to work for the COVID-19 vaccine maker Moderna. In 2022 and 2023, FDA administrators sent emails to several departing staffers, including the two future Moderna employees, saying they could work “behind the scenes” with the agency, despite federal regulatory prohibitions on former FDA employees lobbying Congress or the agency on “matters on which they had previously worked.”

Patrizia Cavazzoni, a psychiatrist, left Pfizer in 2018 to eventually become the head of the FDA’s drug division. While there, she oversaw the controversial approvals of the Alzheimer’s drugs Aduhelm, Leqembi, and Kisunla. During the course of approving Aduhelm, an internal FDA council, which included Cavazzoni, concluded there wasn’t enough evidence that the drug worked. Yet two months later, the drug was approved under her watch.

In an FDA statement, Cavazzoni praised Aduhelm for giving Alzheimer’s patients “an important and critical new treatment.” The company stopped selling the drug three years later, following a congressional investigation and related criticism of the FDA. Cavazzoni retired from the agency on January 18, 2025, just before Trump’s inauguration. Five weeks later, Pfizer announced she would return as its chief medical officer.

The MAHA Mirage

While FDA critics have proposed multiple avenues over the years to address Big Pharma’s lock on the agency, few, if any, go as far as the reforms pledged this year by Trump and Kennedy, his top health czar.

For example, the nine hundred–page Project 2025 plan to remake the federal government under a second Trump administration called for strict rules prohibiting outgoing FDA employees from immediately getting jobs at pharmaceutical companies. The policy agenda also targeted industry money flowing to agencies like the FDA, stating, “Funding for agencies and individual government researchers must come directly from the government with robust congressional oversight.”

Kennedy echoed these sentiments in his official Make America Healthy Again report, released in May 2025. The document called for the end of “corporate capture,” which it defined as “the systematic distortion of scientific literature, regulatory processes, clinical practices, and public discourse by pharmaceutical and health care industries, all aimed at maximizing profits.”

There was also hope in some quarters that Makary, the administration’s choice to helm the FDA, would raise the agency’s drug-approval standards. Makary, formerly a pancreatic surgeon and researcher at Johns Hopkins University Medical Center, has been so committed to improving science at the agency that he was initially a coauthor on the second part of this investigation. (Makary previously coauthored an article in a medical journal with one of the authors of this story.)

But Makary may be hamstrung by an administration bent on deregulation. While Trump has implemented many parts of the Project 2025 agenda, such as dismantling government agencies and rolling back clean-energy initiatives, eliminating industry ties to the FDA has not been among them.

“The 2025 mandate is a classic bait and switch,” says Jerome Hoffman, professor of medicine emeritus at the University of California, Los Angeles. “They correctly diagnose the problem and seem to propose the right solutions that make them sound like populists to get MAGA and MAHA supporters on board.” But according to Hoffman, the programs they’ve put in place “do just the opposite and actually reinforce the status quo… protecting pharma’s profits. And if anybody complains, they will double down on their decisions and blame the media.”

There are already signs that Hoffman may be right. Far from taking steps to reverse the damage caused by drugmakers paying user fees to the FDA, Makary supported the 11.5 percent FDA budget cuts introduced by Elon Musk’s Department of Government Efficiency, which led to mass firings. He then asked Congress to help offset the reductions by increasing the amount of industry user fees the agency could accept from $3.2 billion to $3.6 billion.

In July, Makary appointed George Tidmarsh to head drug approvals. Before his appointment, Tidmarsh, who has been described as a “serial entrepreneur in biopharma,” headed up multiple drug companies, including Horizon Pharma. Under his leadership, Horizon patented the arthritis painkiller Duexis, a combination of two cheap generic drugs, ibuprofen and famotidine, and then jacked up the price. The generics cost the average arthritis sufferer $57 a month. Duexis went for $3,064. (While Duexis is no longer marketed, there’s a $25-a-month generic version available.)

This past Sunday, Tidmarsh resigned amid allegations that he tried to extort and retaliate against a former business associate.

Makary has made some gestures toward reforms. In April, he announced that the FDA would henceforth bar industry representatives from serving on its advisory committees, a move that Fox News characterized as a “major new policy aimed at limiting conflicts of interest.” In reality, industry representatives have never been voting members, and Makary failed to address the extensive financial conflicts of interest among committee members who do vote on drug approvals.

The Lever reviewed the financial ties of one of the most active panels, the oncology committee, which reviews cancer drugs. Before Makary assumed his post, eight of nine voting panelists had financial ties to industry. When the agency assembled a new oncology committee in late May, nine of eleven voting members received money from drugmakers — and in greater amounts than those on the earlier panel. The highest-paid member of the earlier panel received $189,216 in drugmaker payments, including consulting and speaking fees, since 2018, while the highest-paid member of the new panel netted $301,824 in drugmaker payments over the same period.

Now, all such advisory committees, which have served as one of the few public windows into agency decision-making and a check on FDA missteps, may be a thing of the past. Before his resignation, Tidmarsh told industry executives that he views such committees as “redundant” for individual drug approvals. Meanwhile, Makary launched a series of controversial ad-hoc expert panels on topics like hormone therapy and antidepressants, several members of which have financial ties to the drug industry.

Makary’s FDA has turned down a handful of drug applications this year, to the consternation of Wall Street, but at other times, the agency’s efforts to use sound science have been thwarted. Elevidys, a gene therapy for Duchenne muscular dystrophy patients who can still walk, was approved in June 2023 under the Biden Administration, despite the drug’s clinical trial having “failed to demonstrate” the treatment worked. Sarepta, the company behind Elevidys, began marketing the treatments last year at $3.2 million per patient.

In late July, Prasad, an oncologist chosen to head the FDA’s approval of biologic drugs, paused Elevidys sales as one of his first moves at the agency, after three people, including an eight-year-old boy, died of liver failure after getting the treatment. Two days later, Prasad — who has previously coauthored an article in a medical journal with one of the authors of this story — was forced out by Trump, reportedly on the advice of far-right social media influencer Laura Loomer, who denounced him as a “progressive leftist saboteur.”

But in reality, there had been industry pressure behind the scenes. Sarepta and several current and former lawmakers — including Santorum and Senator Ron Johnson (R-Wisc.) — complained to the White House about the hold on Elevidys. The patient advocacy group Parent Project for Muscular Dystrophy, which has financial ties to Sarepta, also urged the FDA to allow sales to proceed, stating that “families are willing to accept substantial risk.”

Prasad was soon reinstated, but the FDA also lifted the hold on sales of Elevidys. Meanwhile, the agency has approved at least two other drugs with little evidence that they work.

In May, regulators authorized Welireg, a tumor drug, based on an incomplete and preliminary study. Then, in September, the agency endorsed Forzinity, a drug for a rare condition called Barth syndrome, even though the FDA staffer who reviewed the single study submitted with the application concluded it “does not meet the statutory requirement of substantial evidence of effectiveness, even in the context of a rare disease.”

Makary has also rolled out a new National Priority Voucher program that promises to reduce the review timeline for selected drugs to as little as one month.

Speeding up approvals is “not always better, and sometimes worse,” says Rita Redberg, a cardiologist at the University of California, San Francisco, and former editor-in-chief of JAMA Internal Medicine. “We do not want to rush dangerous drugs and devices to the market.” Tidmarsh, the former head of the FDA’s drug division, told the New York Times that he faced agency pushback leading up to his resignation because he criticized the new voucher program for injecting politics into drug reviews.

The National Priority Voucher program and other FDA actions have left many experts discouraged about the agency’s prospects for reasserting its regulatory power and halting the influx of questionable drugs onto the market.

“If you have diminished public input, less FDA capacity, and you’re bringing in folks that are deregulatory and industry oriented, the agency, in effect, is not going to be acting as a regulator,” said Yale’s Ramachandran. “It is essentially going to be a rubber stamp.”

This arrangement may suit many drug companies. The industry continues to fill congressional campaign coffers and deploy an army of lobbyists to influence votes on legislation favored by industry. It spends even more money currying favor not just with patient advocacy groups, but also with medical professionals. Nearly 60 percent of the country’s doctors received payments from drug and medical device manufacturers between 2013 and 2022, with more than $12 billion changing hands. Big Pharma also gives an undisclosed amount to physician groups like the American Medical Association.

Pharmaceutical companies also devote millions of dollars to so-called feel-good or unbranded advertisements, with tag lines like “Driven to the cure” and “You’ll get better.” Instead of marketing specific drugs, such advertisements are designed to burnish the industry’s reputation for caring about patients — and by extension, casting doubt on regulators who rule against their products.

In 2021, the top five unbranded pharmaceutical marketing campaigns — such as Abbott Laboratories’ $66 million “Health and Human Dignity” campaign — totaled $216 million.

“Big Pharma has mastered the art of controlling perception and controlling the narrative,” says Witczak, the former FDA drug advisory committee member. “The industry shapes what everybody, from Congress to the media to doctors and patients, believes.”

Ultimately, the industry will find ways to achieve its goals unless Congress passes stronger regulatory measures — a scenario that seems unlikely without campaign finance reform and a change in administration.

With a weak FDA, drugmakers will be free to continue engaging in a kind of legal corruption — and at times even flaunt it. In a recent pay-to-purchase business report carried by the health news website STAT News titled “Failed Trial, Successful Drug,” a drug company consultant explains how pharmaceutical companies can get their drugs “across the transom” at the FDA, even if their clinical trials don’t pass muster.

The secret, he tells drugmakers, is to cultivate “deep and credible relationships” with agency staff and officials, through as many meetings as possible. That’s often all it takes, he writes, to convince regulators to “overlook, discount, or reinterpret negative trial results.”