Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group
Note: Today, Public Citizen’s Dr. Michael Carome joined U.S. Sens. Edward Markey (D-Mass.) and Sherrod Brown (D-Ohio) in a telephone press conference to express concerns about Scott Gottlieb, nominated to head the U.S. Food and Drug Administration (FDA). Below are Dr. Carome’s remarks. Gottlieb’s nomination hearing before the U.S. Senate Health, Education, Labor and Pensions Committee is scheduled for 10 a.m. Wednesday.
During his second week in office, President Donald Trump met with senior executives from several of the world’s leading pharmaceutical companies and promised to cut federal regulations from 9,000 pages to 100 pages, streamline the FDA and accelerate the agency’s review process.
Trump’s nominee to be the next FDA commissioner, Dr. Gottlieb, is entangled in an unprecedented web of close financial and business ties to the pharmaceutical industry and was no doubt chosen because he is well-suited to carry out the president’s reckless, ill-informed vision for deregulating the FDA’s review and approval process for prescription medications, including opioids.
Dr. Gottlieb’s deeply rooted ties to Big Pharma span more than a decade. Since 2007, he has been a venture partner at New Enterprise Associates, which proclaims to be “one of the world’s largest and most active venture capital firms.” According to the firm’s website, New Enterprise Associates invests in biopharmaceuticals medical devices and health care services, among other things.
Moreover, at the time of his nomination, Dr. Gottlieb was serving or had recently served on several pharmaceutical companies’ boards, including the Product Investment Board of GlaxoSmithKline — one of the world’s largest drug manufacturers. According to the federally mandated Open Payments database that tracks industry payments to physicians, from August 2013 (when the database began operating) through December 2015, Dr. Gottlieb received a total of $414,000 from multiple drug and medical device companies – including Pfizer (the maker of an extended release oxycodone opioid product), AstraZeneca, GlaxoSmithKline, Bristol-Myers Squibb and Valeant Pharmaceuticals – mostly for consulting and speaking fees. These relationships certainly would frame his thinking and approach to the FDA’s oversight of drugs and other medical products.
Dr. Gottlieb’s recently released letter to the U.S. Department of Health and Human Services designated ethics official indicates that if confirmed as FDA Commissioner, he will recuse himself for specified periods of time from particular matters involving approximately 20 companies with which he has had financial or other ties. But this is not sufficient: Dr. Gottlieb will be involved in numerous broad policy and regulatory decisions that will impact the financial bottom lines of the many companies that he has been tied to for years. No amount of recusals will be sufficient to disentangle him from these financial conflicts of interest and ensure that he will put public health before industry profits.
Aside from the tangle of industry ties, Dr. Gottlieb has advocated a dangerous deregulatory approach to the review process for new medications. In exchange for getting medications to the market faster, he believes that the FDA must be willing to accept a greater degree of uncertainty about the drugs’ safety and efficacy at the time of approval.
He also has questioned the FDA’s use of risk evaluation and mitigation strategies (REMS) to ensure safe drug use, challenging the FDA’s authority to impose requirements for such plans on pharma companies. The FDA currently relies on REMS plans as one tool to try to ensure the safe use of many medications.
Dr. Gottlieb’s appointment would further accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry than those of patients. We urge other senators to join with Senators Markey and Brown in opposing Dr. Gottlieb’s nomination. The Senate should demand a nominee who is better suited to protect public health, rather than a venture capitalist who is ridden with conflicts of interest.