Opioid painkillers that have led to thousands of deaths and new drug addicts should be the highest priority of the U.S. Food and Drug Administration, said Scott Gottlieb, President Donald Trump’s pick to lead the agency.
“The opioid epidemic in this country has staggering human consequences,” Gottlieb said Wednesday in a hearing before the Senate Committee on Health, Education, Labor and Pensions. “I think this is the biggest crisis facing the agency.”
Likening the widespread abuse of opioids to the outbreak of Ebola virus that ran rampant in West Africa, Gottlieb said that the agency would have to pursue a number of paths, such as working with drugmakers seeking approval for alternatives and abuse-deterrent versions of the drugs. More than 33,000 people died from opioid overdoses in 2015, according to the U.S. Centers for Disease Control and Prevention.
The agency would “push the policy boundaries” for approval of safer opioids and other alternatives if he’s confirmed, Gottlieb said. “It’s going to be an all-of-the-above approach.”
Gottlieb is likely to be confirmed by the full Senate when he eventually gets a vote. His comments to the committee Wednesday seemed to assuage concerns by some senators on the drug crisis as well as other issues, including potential conflicts of interest that come from his work as a consultant and investor.
A former FDA staffer who left the agency to work in the business world, Gottlieb also faced questions on his ties to health-care companies. Financial disclosure forms show he earned millions of dollars from various investment banks and pharmaceutical firms last year and in the first part of this year, including $1.85 million for his work as a managing director at T.R. Winston & Co., an investment bank that raised money for a number of public companies.
“You do wear an extraordinary number of hats,” said Sen. Patty Murray, a Democrat from Washington.
Gottlieb replied that at the FDA, he would be guided by science. If confirmed, he would resign from T.R. Winston, divest interests in more than a dozen companies and temporarily recuse himself from making decisions on at least 20 more where he has financial interests or was paid consulting fees, including GlaxoSmithKline and Bristol-Myers Squibb.
“The lives and the futures of families like mine are affected by the decisions made by the FDA,” Gottlieb, whose wife, children and parents were at the hearing, said in his opening statement. He pledged to make sure “the FDA puts their interests first in everything we do.”
Gottlieb has previously spoken about lowering drug prices, a Trump priority, by speeding approval of generic drugs. He’s particularly focused on complex medications that combine old drugs with newer delivery devices, as well as those with unusually complicated formulations.
In his prepared remarks, Gottlieb urged rejection of what he called a “false dichotomy that it all boils down to a choice between speed and safety.” Instead, he wrote, if the FDA leverages new technology and better science it can improve efficiency and safety “and also remain faithful to FDA’s gold standard for regulatory conduct.”
Gottlieb, 44, served as a deputy FDA commissioner from 2005 to 2007. He hasn’t faced the same criticism from Democrats that other Trump administration choices have, such as Health and Human Services Secretary Tom Price and Supreme Court justice nominee Neil Gorsuch.
In addition to his consulting and investment work since leaving the agency, Gottlieb has also been a fellow at the American Enterprise Institute, a conservative-leaning Washington think tank. He was trained as a physician and completed his residency in internal medicine at Mount Sinai Medical Center in New York after graduating from the Mount Sinai School of Medicine in 1999. He earned a degree in economics from Wesleyan University in 1994.
Original article via TheCannabist