Scott Gottlieb: 5 Fast Facts You Need to Know

Dr Scott Gottlieb Worries About More FDA Regulation in Diagnostic TestingWatch more AJMCtv interviews with industry experts at http://www.ajmc.com/interviews2015-11-21T15:24:21.000Z

Scott Gottlieb is expected to be President Donald Trump’s pick for commissioner of the Food and Drug Administration.

Gottlieb is a physician and health policy analyst who previously worked in the Food and Drug Administration under President George W. Bush and who has ties to the pharmaceutical industry. His nomination will have to be approved by the Senate.

Here’s everything you need to know about Scott Gottlieb, the possible next head of the Food and Drug Administration.


1. He Has Ties to the Pharmaceutical Industry & Received Over $400,000 in Consulting Fees Between 2013 and 2015

Scott Gottlieb: Obamacare's cap on medical-loss ratiosThird-party photos, graphics, and video clips in this video may have been cropped or reframed. Music in this video may have been recut from its original arrangement and timing. In the event this video uses Creative Commons assets: If not noted in the description, titles for Creative Commons assets used in this video can be found at the link provided after each asset. The use of third-party photos, graphics, video clips, and/or music in this video does not constitute an endorsement from the artists and producers licensing those materials. AEI operates independently of any political party and does not take institutional positions on any issues. AEI scholars, fellows, and their guests frequently take positions on policy and other issues. When they do, they speak for themselves and not for AEI or its trustees or other scholars or employees. More information on AEI research integrity can be found here: http://www.aei.org/about/ #news #politics #government #education2013-11-04T21:12:50.000Z

Scott Gottlieb is a partner at New Enterprise Associates, a venture capital firm with over $18 billion in assets.

In addition, he is a director at Tolero Pharmaceuticals and Daiichi Sankyo Inc., and is on the investment board of GlaxoSmithKline. Finally, he is a partner at T.R. Winston, a merchant bank with a focus on health care.

According to The Washington Post, Gottlieb received $413,000 in consulting and speaking fees from these pharmaceutical companies between 2013 and 2015.

“He is basically entangled in an unprecedented web of ties to big pharma,” Dr. Michael Carome, the director of the health research group at Public Citizen, told The New York Times. “He is someone who has been an industry shill and has spent most of his career dedicated to promoting the financial interests of pharmaceutical corporations.”


2. He Previously Worked at the Food & Drug Administration Under George W. Bush

The FDA Should Not Mandate Comparative-Effectiveness Trialshttp://www.aei.org/Outlook AEI's Scott Gottlieb, MD explains why new FDA regulations to mandate comparative-effectiveness trials would hurt consumers and businesses and are unnecessary. For more information, please read Scott's new Outlook at http://www.aei.org/Outlook Third-party photos, graphics, and video clips in this video may have been cropped or reframed. Music in this video may have been recut from its original arrangement and timing. In the event this video uses Creative Commons assets: If not noted in the description, titles for Creative Commons assets used in this video can be found at the link provided after each asset. The use of third-party photos, graphics, video clips, and/or music in this video does not constitute an endorsement from the artists and producers licensing those materials. AEI operates independently of any political party and does not take institutional positions on any issues. AEI scholars, fellows, and their guests frequently take positions on policy and other issues. When they do, they speak for themselves and not for AEI or its trustees or other scholars or employees. More information on AEI research integrity can be found here: http://www.aei.org/about/ #news #politics #government #education2011-06-10T17:45:54.000Z

If Gottlieb is confirmed, he will be returning to the government agency that he worked for during the administration of George W. Bush

From 2005 through 2007, Gottlieb was the deputy commissioner for medical and scientific affairs at the Food and Drug Administration. Before ascending to this position, he had worked as a senior advisor to the Food and Drug Administration’s commissioner.

Gottlieb’s ties to the pharmaceutical industry became a bit of an issue when he previously worked at the Food and Drug Administration. For instance, in 2005, he recused himself from the planning of the United States’ response to a bird flu epidemic because he had in the past done consulting work for companies whose products may be used to combat the bird flu, according to Boston.com.

Gottlieb said at the time that a ”reasonable person would question my impartiality” in matters related to the pharmaceutical companies that he has done consulting work for.


3. He Once Criticized Donald Trump’s Rhetoric About Drug Pricing

Dr. Scott Gottlieb Discusses the Ebola CrisisAs the Ebola outbreak continues to be an international crisis, the United States' involvement is key to contain the epidemic in West Africa. Dr. Scott Gottlieb of the American Enterprise Institute discusses why we need to send more healthcare workers to Africa, how individuals can better prevent the spread of disease in the U.S. as well as what the federal and state governments should do to address mandatory quarantines on citizens, particularly healthcare workers like Kaci Hickox, who may have been exposed to the virus.2014-10-31T20:59:55.000Z

Scott Gottlieb has written a number of op-eds for outlets like The Washington Post and Forbes, and in one from 2016, he expressed some disagreement with Donald Trump.

This op-ed came amid the Republican presidential primaries, during which Donald Trump was talking about importing drugs from other countries that impose price controls as a way of circumventing costs. In Gottlieb’s piece for Forbes, he says that Trump’s plan is “perhaps good politics” but that it will “offer consumers little relief.”

He goes on to say that the real prices that consumers paid for prescription drugs has grown in recent years, but at a slower pace than usual. However, he says that these savings have not really been reaching the average person, and he points to Obamacare as a reason for this.

“Consumers are being forced into health plans that have very narrow and often ‘closed’ drug formularies,” he writes. “These insurance schemes often don’t provide any coverage for many important medicines. Where health plans cover a drug, consumers are getting stuck with rising co-pays and out-of-pocket costs. Obamacare has popularized these super skinny drug plans — not only in the health plans sold inside the Obamacare exchanges, but in employer-sponsored coverage as well. We have a growing ‘coverage gap’ when it comes to branded prescription drugs.”

He also says that Donald Trump’s idea of drug importation won’t work and that the drugs would actually end up being quite expensive.

“[U]nder any reasonable scheme, the importation would be confined to drugs from facilities that have already undergone FDA inspection, and produce foreign-approved versions of medicines already sold in the U.S,” he says. “But the branded firms own those facilities. They’re not going to simply ramp up the production lines to accommodate new demand, if it means that the drugs will be imported into the U.S. to skirt their tiered pricing. Nor will the foreign countries allow their local supply to be skimmed off, only to create local shortages of important medicines.”

In addition, he says that any drug importation plan like the one Trump was talking about would require a fair amount of regulatory oversight, and in the end it would add “so much cost to the imported drugs” that “they wouldn’t be much cheaper than drugs sold inside our closed American system.”

In April 2012, Gottlieb tweeted a link to an article criticizing Donald Trump’s comments on vaccines.


4. He Wants to Speed Up the Approval of Generic Drugs

Scott Gottlieb of American Enterprise Institute on policy at World Orphan Drug Congress USA '13Scott Gottlieb, Resident Fellow at the American Enterprise Institute, presented at World Orphan Drug Congress USA 2013 on the topic, 'How to stimulate orphan drugs R&D through policy opportunities.' World Orphan Drug Congress USA is the largest international, commercially-focused event for the advancement of rare disease research and orphan drug development. For more information, go to http://www.terrapinn.com/orphandrug. Or, check out our blog at blogs.terrapinn.com/total-biopharma for up to date information on the orphan drugs and rare disease.2013-05-15T21:12:27.000Z

In order to to bring down the cost of prescription drugs, Scott Gottlieb says that the Food and Drug Administration must work to speed up the approval process of generic drugs.

Gottlieb has said that he wants to overhaul the rules for complex generic drugs so that companies can not create “monopolies in perpetuity,” according to Bloomberg.

He is also in favor of faster drug approvals, criticizing the Food and Drug Administration for slowing the process down with its rules and regulations.

“This hunger for extreme certainty about how drugs work — born of an inability to trust doctors to do their jobs — is essential to understanding the FDA’s evolving approach to drug trials,” he wrote in a piece for National Affairs. “The agency’s concern is not chiefly that a new drug will go on to have some serious side effect that agency staff failed to discover before approval; the modern FDA is exceedingly good at unearthing common, and even remote, risks.”


5. He Married Allyson Brooke Nemeroff in 2004

Dr. Scott Gottlieb: Obamacare is throwback to HMOs; Restricts doctor choice & pharmaceuticalsAEI Fellow Dr Scott Gottlieb was on Fox News Sunday today and talked about Obamacare is really the HMOs from the 1990s reincarnated. The HMOs restrict doctor choice and the availability of pharmaceuticals in an effort to lower costs and Obamacare is doing the same thing.2013-12-29T19:12:57.000Z

According to The New York Times, Scott Gottlieb married Allyson Brooke Nemeroff in 2004.

At that time, Allyson Brooke Nemeroff was the the national advertising director for The New York Sun, a conservative newspaper. The wedding took place at the Women’s National Republican Club in Manhattan.

Gottlieb is originally from East Brunswick, New Jersey, and he currently lives in Westport, Connecticut.