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FDA nominee Gottlieb's business ties examined in senate hearing
By JIM RUTLEDGE
D.C. Correspondent 
 
WASHINGTON, D.C. — During his U.S. Senate confirmation hearing, the White House nominee to head the Food and Drug Administration (FDA), Dr. Scott Gottlieb, pledged, “I want to earn and keep the public’s trust,” in responding to criticism about his extensive relationships with 20 health care companies, including some pharmaceutical giants that as the FDA commissioner he would regulate.
 
Gottlieb, a physician and entrepreneur who has invested in more than 60 drugs, appeared before the 22-member Senate Health, Education, Labor and Pensions Committee on April 5. Financial disclosure documents he filed with the government’s ethics office show in recent years he has held more than a dozen positions and received millions of dollars in income as advisor, executive, paid speaker or consultant to dozens of companies.
 
Committee Ranking Member Patty Murray (D-Wash.) said his relationships showed “unprecedented financial entanglements,” with the drug industry since he left government in 2007. He served as deputy FDA commissioner under former President George W. Bush. Republicans on the panel said on the other hand, Gottlieb’s relationship with the health care industry could be a valuable asset in running the FDA, an agency responsible for the nation’s food safety and the health of the American people. “I think we are very fortunate that you are willing to do this, with the vast experience that you have,” said Sen. Orrin Hatch of Utah.
 
Gottlieb has promised to recuse himself for a year on cases involving more than 20 companies he has advised or invested in over the past 10 years, he told officials at the Office of Government Ethics.
 
In opening remarks before the committee, he said he recognizes the importance of the FDA’s work, both as a doctor and as a cancer survivor having been successfully treated for Hodgkin’s lymphoma.
 
He also said he would keep his independence from the White House, and opposes President Donald Trump’s interference on policy matters, especially with regard to vaccinations that could cause autism. In the past Trump has tweeted there could be a link, which the medical field has debunked.
 
Among his vast i n v e s t m e n t s , Gottlieb has supported cancertherapy startups, Cell Biotherapy, Inc. and industry drug giants GlaxoSmithKline PLC and Bristol-Myers Squibb, Inc. As an investor, he served as a venture partner with New Enterprise Associates, a large venture capital firm heavily invested in medical technology and health care, and as managing partner and investment consultant with T.R. Winston & Co. FDA commissioners rarely get involved in company-specific decisions, instead directing policy decisions that cover entire industries.
 
One of Gottlieb’s first challenges, if confirmed, will to carefully review the White House’s 2018 budget request in which Trump is proposing hiking FDA user fees paid by health care companies for reviewing their products, including drugs and medical devices. Trump wants to raise fees to more than $2 billion, twice as much as in 2017.
 
In the end those fees would be passed on to consumers as higher drug prices, complicating efforts by the FDA, which has announced it wants to reduce drug prices.
 
Gottlieb has said he also wants to speed up the drug approval process, a problem that has lawmakers and the White House anxious to find a fix.
 
Since 1992, the FDA has been charging companies to review their products. However, most of the user fees are collected for prescription drugs - $866 million this year alone, including $324 million for generic drugs. Among those affected will be companies that discover new medicines for the agricultural industry to treat farm animals, with the market now focused on reducing antibiotics use.
 
Gottlieb would have to jump into the budget process while Trump wants to cut heavily into the Health and Human Services budget by 18 percent, or $15.1 billion (including the FDA’s $5.1 billion budget), a blow to research dollars all around. Hardest hit would be the National Institute of Health (NIH), where Trump wants to chop $5.8 billion from its $31.7 billion budget.
4/12/2017