The doctor nominated to head the powerful Food and Drug Administration told senators Wednesday that his first priority would be tackling the opioid crisis, and he pledged that science will prevail at the agency despite his extensive financial ties to medical companies it regulates.
Dr. Scott Gottlieb is a physician-turned-health consultant who has criticized many FDA regulations as unnecessary and has what opponents call unprecedented financial entanglements.
But Gottlieb told a Senate health committee that as a cancer survivor, he knows firsthand the importance of “what the FDA does for every one of us” and promised to “lead the FDA as an impartial and passionate advocate for public health.”
He stressed the balance between speeding new products to market and making sure that good science continues to guide the FDA’s decisions.
“We should reject a false dichotomy that it all boils down to a choice between speed and safety,” Gottlieb said. At the same time, “we need to make sure we’re getting the most bang for our regulatory buck,” he added.
Gottlieb said opioid addiction is “the biggest crisis facing the agency” and as serious a public health challenge — for the entire government, not just FDA — as infectious diseases like Ebola or Zika. He said tackling the crisis would be his first priority and will “require dramatic action,” including finding ways to spur development of non-addictive alternative painkillers as well as addiction treatments.
Gottlieb, 44, is no stranger to the FDA, which regulates products that affect about a quarter of all consumer spending — everything from new drugs and medical devices to food safety, nutrition labeling, tobacco and e-cigarettes, animal drugs and cosmetics. He was a deputy commissioner under President George W. Bush.
“My hope is that you will help move the agency forward so that America’s patients benefit from the remarkable discoveries our nation’s researchers are working on,” said Sen. Lamar Alexander, R-Tenn., who chairs the Senate Health, Education, Labor and Pensions Committee.
But critics have focused on Gottlieb’s finances, citing government data showing he received hundreds of thousands of dollars in consulting or other fees from several FDA-regulated companies in recent years, on top of income from positions in a venture capital firm and investment bank that also fund health companies.
In ethics documents filed last week, Gottlieb said that if confirmed as FDA’s commissioner he would recuse himself for a year from decisions involving about 20 companies, including drug giant GlaxoSmithKline, and would resign positions including as a board member or consultant with nine other health-related companies. Gottlieb also is a resident fellow at the conservative American Enterprise Institute, from which he said he also would resign.
But Sen. Patty Murray of Washington, the committee’s senior Democrat, questioned whether recusals are enough to erase the bias of being a pharmaceutical industry insider when dozens of drugs being developed by those companies could come before the FDA.
“What I’m concerned about is how your involvement with so many companies shapes your priorities,” she said.
Gottlieb responded, “I get it. I understand how important the impartiality of this agency is so people continue to have trust in the decisions FDA makes.”
“I want to earn and keep the public’s trust,” he said.
Other issues raised Wednesday:
—Gottlieb made clear that he disagreed with President Donald Trump’s contention that vaccines may be linked to autism. Gottlieb said that has been “one of the most exhaustively studied questions in scientific history” and it was time to accept the conclusions of those studies that “there is no causal link.”
—Gottlieb said he was committed to tobacco control, saying, “I am not going to countenance a rise in adolescent smoking rates in this country under my watch.” Pressed on e-cigarettes that increasingly come with kid-friendly flavors like gummy bears, Gottlieb said vaping has a role in helping established smokers quit but that with the flavorings, “I recognize there is a line here somewhere and I don’t know where that line gets drawn.”
—On drug pricing, Gottlieb said it was time to adjust FDA policies that make it difficult to quickly approve lower-cost generic versions of certain treatments, particularly drug-and-device combinations.
—As for FDA’s food side, Gottlieb deferred questions about advice on seafood consumption during pregnancy, genetically engineered salmon and new nutrition labels set for next year, saying he needed to hear from FDA’s scientists and staff.
(Source: Associated Press)