Thanks to the U.S. Food and Drug Administration’s (FDA) management – or mismanagement – of the COVID-19 pandemic, trust in the agency has never been lower. As a trail of industry-enriching COVID-19 drugs are approved and safety questions are labeled “misinformation,” many wonder if the regulatory agency is serving industry rather than consumers. The FDA, like the Center for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), is a division within the Department of Health and Human Services or HHS.
Concerns about conflicts of interest (COIs) at the FDA-drug makers essentially “buying” drug approvals-are not new as the agency is notoriously underfunded and drug makers are highly moneyed. Passage of the Prescription Drug User Fee Act or PDUFA in 1992 – in which drug makers pay “user fees” for their drug candidate to be considered for approval – crystalized the problem.
The user fees constitute “$2.9 billion of the FDA’s $6.5 billion 2022 budget, including two-thirds of the drug regulation budget,” wrote the Kaiser Family Foundation in 2022. “Companies in recent years have paid between $2.5 million and $3 million to have each drug application reviewed.”
“While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs,” Ronald Kavanagh, an FDA drug reviewer from 1998 to 2008, said in an interview.
Another conflict of interest concern derives from the many medically trained people who have financial links to drug makers either through consultancy fees or stock ownership.
FDA Commissioners Have Been Controversial
In March of 2017 President Trump chose Dr. Scott Gottlieb to serve as FDA Commissioner and he was confirmed by Senate. Dr. Gottlieb “has been a frequent consultant to drug companies, serving on advisory boards for large pharmaceutical companies like GlaxoSmithKline and Daiichi Sankyo,” and “paid millions by industry,” wrote the New York Times. “He has also invested significantly in the health care industry, most recently through the venture capital firm New Enterprise Associates and T. R. Winston & Company, an investment bank.”
Dr. Gottlieb did not hide his pro-drugmaker sentiments. After the Bush Justice Department served Eli Lilly with a criminal indictment while Dr. Gottlieb was FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007, he wrote a Wall Street Journal opinion piece titled “Stop the War on Drugs” upon leaving the agency.
But, when it comes to drug maker “foxes” guarding the FDA “hen house,” both sides of the aisle appear to have a high tolerance of ambiguity. In 2021, President Biden nominated (and the Senate confirmed) Dr. Robert Califf to serve as FDA Commissioner, a position he had also held under President Barack Obama.
Dr. Califf’s largesse toward drug makers was no secret either. “Many of us consult with the pharmaceutical industry, which I think is a very good thing,” he said on PBS television in 2004. “They need ideas and then the decision about what they do is really up to the person who is funding the study.” While at Duke university, before his Obama position, Dr. Califf presided over a subsequently-discredited drug trial of the blood thinner Xarelto.
Dr. Margaret Hamburg, the FDA commissioner who preceded, Dr. Califf also came under the ethical microscope after she left office in 2015. A lawsuit charged that “she and her husband, Peter Brown, who became co-CEO of Setauket-based Renaissance Technologies in January 2010, benefited substantially from his firm’s ownership of pharmaceutical stocks whose medications the FDA approved,” reported the Long Island Business News.
The possible conflict of interest was especially ironic in light of the fact that Dr. Hamburg had lamented in 2011 that the government could not find enough experts who were not funded by drug makers to serve on advisory committees (which make recommendations to FDA staff) and suggested that the FDA’s conflict of interest rules be loosened.
Conflicts Are Not Limited to the FDA
Many will remember that President Trump nominated Alex Azar in 2017, former president of Eli Lilly, to be Health and Human Services secretary. The sprawling, Cabinet-level HHS includes 11 agencies that operate more than 100 programs.
While Derrick Z. Jackson, a Union of Concerned Scientists Fellow, cast the nomination as a conflict of interest, concern over high drug prices seemed to override Azar’s drug executive resume. For example, during confirmation hearings, Sen. Ron Wyden (D-Ore.) asked Azar if he ever decided to lower the price of a drug while president of Eli Lilly. Azar was confirmed by the Senate in 2018.
Is anyone surprised that such conflicts of interest result in the approval and marketing of dangerous drugs? The drugs Vioxx, Bextra, Baycol, Trovan, Meridia, Seldane, Hismanal, Darvon, Raxar, Redux Mylotarg, Lotronex, Propulsid, phenylpropanolamine (PPA), Prexige, phenacetin, Oraflex, Omniflox, Posicor, Serzone were all withdrawn after FDA approval, raising questions about why they were ever approved.