FDA Nominee Understands Opioid Crisis Is An Emergency
During his confirmation hearing before the Health, Education, Labor and Pensions Committee, Gottlieb described the FDA as “complicit, even if unwittingly,” in helping to fuel the opioid epidemic. Officials, he said, “didn't fully recognize the scope of the emerging problem” several years ago and needed a new strategy to combat the issues involved.
Developing that strategy, he added, would be his “highest and most immediate priority” and would involve taking a hard look at the FDA's framework for approving painkillers and pressing for greater availability of nonaddictive painkillers.
Gottlieb, a high-ranking FDA official during the George W. Bush administration, was welcomed warmly by Republicans, who praised his experience in industry, medicine and the government. With strong support from Chairman Lamar Alexander (R-Tenn.), his confirmation seems all but assured. The committee vote is at least two weeks away because of an upcoming congressional recess.
The nominee took some flak from Democrats, who worried that his long-standing financial ties to the pharmaceutical industry would impair his ability to regulate it.
Sen. Patty Murray (D-Wash), the panel's ranking minority member, said she remained uneasy about Gottlieb's “unprecedented entanglements” with the industry, despite his agreement to recuse himself for a year from any decisions involving more than 20 companies with which he has had financial relationships since leaving the government in 2007.
“I do struggle to see how this means your views are not shaped by your investments,” she said, adding that she's also concerned President Trump, who has described the FDA drug-approval process as “slow and burdensome,” might pressure him to lower safety and efficacy standards to speed products to market.
But the 44-year-old Gottlieb, who worked for New Enterprise Associates, one of the world's largest venture capital firms, pledged to be an “impartial and passionate advocate for public health” and said that there is “one standard for safety and effectiveness, and no commissioner can change that.”
During the hearing, he was questioned on a variety of issues, including vaccine safety. Trump has repeatedly suggested that there is a link between vaccines and autism — a widely discredited theory.
Gottlieb said the purported vaccines-autism link has been “one of the most exhaustively studied questions” in scientific history. Now, he said, “We need to come to the point where we can accept no for an answer and come to the conclusion that there is no causal link between vaccination and autism.”
His comments on opioids came a day after two Democratic senators whose states have been ravaged by prescription painkillers — Edward J. Markey of Massachusetts and Sherrod Brown of Ohio — came out in opposition to his nomination. Both argued that Gottlieb's record, as well as his extensive writings on FDA issues, suggested that he didn't support using the necessary tools to fight the epidemic.
In particular, they criticized a 2012 article in which he questioned the Drug Enforcement Administration's efforts to police opioids. He wrote that the DEA's approach was “burdening a lot of innocent patients” and suggested that some of its responsibilities be turned over to the Department of Health and Human Services.
During the hearing, Sen. Tim Kaine (D-Va.) urged Gottlieb to aggressively scrutinize pain management in general and to seek additional help from Congress if needed. Late last month, Trump appointed a high-profile commission, chaired by New Jersey Gov. Chris Christie (R), to combat the crisis. Gottlieb was not immediately named as a member, and it's not clear whether he will join if confirmed as FDA commissioner by the Senate.
Gottlieb said he would take an “all-of-the-above approach” in trying to find solutions to the opioid problem but also added that the issue has become too big for the FDA to solve on its own.
“This is a staggering human tragedy that is going to require dramatic action on the part of the agency,” he said. He acknowledged that the agency's response had been “too incremental” over the years, though he said he wasn't criticizing his predecessors.
Much of the hearing — and most of the Democratic senators' questions — focused on Gottlieb's business connections to the drug industry. After serving as deputy FDA commissioner, he worked for numerous companies and investment firms in a variety of roles, including as a consultant, paid speaker, investor and adviser.
Gottlieb said he would take additional steps to ensure that neither he nor the agency is compromised by his prior relationships with industry. He already has stepped down from various boards and sold his interests in several health-care companies, he said in an ethics agreement he recently filed with federal officials.
Content Originally Published By: Laurie McGinley @ The Washington Post