Login
Subscribe
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 Food and Drug Administration (FDA), and accelerate the agency’s drug review process.[1]
And on March 10, Trump announced the nomination of Dr. Scott Gottlieb to be the next FDA commissioner. Gottlieb is entangled in an unprecedented web of close ties to the...
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 Food and Drug Administration (FDA), and accelerate the agency’s drug review process.[1]
And on March 10, Trump announced the nomination of Dr. Scott Gottlieb to be the next FDA commissioner. Gottlieb is entangled in an unprecedented web of close ties to the pharmaceutical industry and, therefore, was chosen because he is well-suited to carry out Trump’s reckless, ill-informed vision for deregulating the FDA’s review and approval process for prescription medications.[2]
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 (NEA),[3] which proclaims to be “one of the world’s largest and most active venture capital firms."[4] According to the firm’s website, NEA invests in biopharmaceuticals and medical devices, among other things.
Moreover, at the time of his nomination, 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.[5] According to a federally mandated database that tracks industry payments to physicians, from August 2013 (when the database began operating) through December 2015, Gottlieb received a total of $414,000 from multiple drug and medical device companies — including AstraZeneca, GlaxoSmithKline, Pfizer, Squibb and Valeant Pharmaceuticals — mostly for consulting and speaking fees.[6]
From 2005 to 2007, Gottlieb served as an FDA deputy commissioner. Because he had financial ties to many pharmaceutical companies prior to that appointment, he was required to recuse himself from key meetings and decisions involving these companies.[7] If the Senate does not reject Gottlieb, no amount of recusals will ensure that he will put public health before industry profits.
Aside from the tangle of industry ties, Gottlieb has advocated a dangerous deregulatory approach to the review process for new medications. In exchange for getting medications to the market faster, Gottlieb believes the FDA must be willing to accept a greater degree of uncertainty about the drugs’ safety and efficacy at the time of approval.[8] He also has favored looser restrictions on drug companies promoting drugs for uses that have not been approved by the FDA, a practice known as off-label promotion.[9]
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. The Senate must reject Gottlieb and demand a nominee who is better suited to protect public health, rather than a conflict-of-interest-ridden venture capitalist.
References
[1]STAT staff. Transcript: Trump tells pharma execs ‘We’re gonna streamline the FDA.’ January 31, 2017. STAT. https://www.statnews.com/2017/01/31/transcript-trump-pharma/. Accessed March 16, 2017.
[2]The White House Office of the Press Secretary. President Donald J. Trump announces key administration post. March 10, 2017. https://www.whitehouse.gov/the-press-office/2017/03/10/president-donald-j-trump-announces-key-administration-post. Accessed March 16, 2017.
[3]Linked In. Scott Gottlieb. https://www.linkedin.com/in/scottgottliebmd/. Accessed March 16, 2017.
[4]NEA. One team. A world of opportunity. http://www.nea.com/about. Accessed March 16, 2017.
[5]Linked In. Scott Gottlieb. https://www.linkedin.com/in/scottgottliebmd/. Accessed March 16, 2017.
[6]OpenPayments Data.CMS.gov. Scott Gottlieb. https://openpaymentsdata.cms.gov/physician/89830/payment-information. Accessed March 16, 2017.
[7]Gottlieb S. Memo to Lester M. Crawford, FDA Commissioner. August 5, 2005. http://www.citizen.org/documents/050000recusalletter.pdf. Accessed March 16, 2017.
[8]Gottlieb S. Changing the FDA’s culture. National Affairs. 2012 Summer;12:108-121.
[9]Gottlieb S. From FDA, a good framework for distributing information on off-label uses. April 23, 2008. Health Affairs Blog. http://healthaffairs.org/blog/2008/04/23/from-fda-a-good-framework-for-distributing-information-on-off-label-uses/. Accessed March 16, 2017.
