President Trump has nominated Scott Gottlieb as the next Commissioner of the U.S. Food & Drug Administration (FDA). We strongly oppose Gottlieb’s nomination and sent the letter below to The Honorable Lamar Alexander, Chairman of the Committee on Health, Education, Labor & Pensions.
Dear Mr. Chairman,
Breast Cancer Action is strongly opposed to the nomination of Scott Gottlieb as the next Commissioner of the U.S. Food and Drug Administration (FDA). Our opposition stems from concerns regarding Dr. Gottlieb’s strong industry ties and resulting conflict of interest, as well as his views on loosening FDA regulations that threaten to undermine patient protection.
Breast Cancer Action (BCAction) is a national education and activist organization working to achieve health justice for all women at risk of and living with breast cancer. Since our founding 27 years ago, we work to ensure that women have access to evidence-based information about breast cancer, free of industry influence. BCAction has over 60,000 members across the U.S.
We have deep concerns about Dr. Gottlieb’s strong ties to the pharmaceutical and biotechnology industries. He serves as a consultant or advisor to companies such as Gradalis, Glytec, Tolero Pharmaceuticals, GlaxoSmithKline, and Vertex Pharmaceuticals. According to ProPublica, he received more than $400,000 in payments from pharmaceutical companies between 2013 and 2015, and Harvard University’s Dr. Daniel Carpenter, who wrote a history of the FDA, stated that if confirmed, Gottlieb would be “the most interest-conflicted commissioner in American history.” We cannot trust someone so deeply connected to industry to be able to put patient interests first and foremost. In addition, his industry ties resulted in his recusal from many key decisions during his previous tenures with the FDA, which gives us great concern were he to serve as FDA Commissioner.
We are specifically concerned that Dr. Gottlieb has been a long-time advocate for loosening approval requirements for new medical products; speeding the process for approving complex generics; and increasing flexibility in the clinical trial process. The FDA already approves new drugs faster than any other developed country. And the agency is currently on the path to even speedier drug approvals; the recently passed 21st Century Cures legislation is a prime example. We are gravely concerned that Dr. Gottlieb’s appointment will focus on accelerating this process at the expense of safety and efficacy standards. Rather than benefitting patients, there is a very real risk that shortchanging the approval process may result in a greater risk of side effects or, worse, lethality with no guarantee of efficacy.
We are additionally opposed to Dr. Gottlieb’s nomination given his criticism of government restrictions on how companies could market drugs for off-label uses. We need an FDA Commissioner who will uphold the agency’s role of ensuring that clinical decision-making is informed by strong clinical evidence on a drug’s intended use.
Patients and consumers depend on the FDA to protect the public’s health and safety. We believe that an FDA Commissioner with such strong industry ties and a history of criticizing regulation is not the right candidate. On behalf of all women at risk of and living with breast cancer, we urge you to reject Dr. Scott Gottlieb’s nomination.
Executive Director, Breast Cancer Action