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FDA Nominee Scott Gottlieb To Anti-Vaccine Crowd: Get Over It

Xconomy National — 

In what passes for a short hearing these days in Washington, DC, the Trump White House’s pick to run the Food and Drug Administration, Scott Gottlieb, spent less than three hours fielding questions from a Senate committee Wednesday morning.

Amid predictable splits between Republican praise for his past industry experience and Democrat fire over potential conflicts that stem from his private industry investments and consulting work, Gottlieb took very public issue with one of President Donald Trump’s high-profile grievances. Gottlieb was unequivocal that the anti-vaccine movement, newly emboldened by Trump’s vaccine skepticism, was tilting at windmills.

“This has been one of the most exhaustively studied questions in scientific history,” Gottlieb 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. We’ve invested, and Congress has invested, enormous resources in studying this question.”

Gottlieb painted himself as unafraid to push back against potential pressure from his bosses. “I have a history of not being shy, about speaking truth to power,” he said, and would make his views known “in the proper venues.”

Gottlieb, 44, who served in the FDA from 2005 to 2007 in the George W. Bush administration, also spoke forcefully about the nation’s opioid abuse crisis. Senators from both sides asked Gottlieb what FDA could do about the situation, which he called a public health emergency “on the level of Ebola and Zika” that requires the “full gamut of public resources.”

Gottlieb was cautious, however, in noting that much of the difficult work lies outside the FDA’s purview. He was similarly cautious describing specific potential FDA action, referring to regulatory “frameworks” and statutes that the agency must follow—or that Congress has to change. “We might have to come back to Congress,” he said, “and have another conversation with all of you about how to make these things happen.”

Sen. Al Franken (D-MN) noted that the price of a life-saving injection of the anti-overdose drug naloxone, which many first responders carry on the job, has jumped dramatically since 2014. Gottlieb responded that FDA regulations could perhaps be tweaked to allow generic competition for high-priced drugs. Speaking more broadly about lack of generic competition, which has helped some products monopolize the market “in perpetuity,” Gottlieb told the Senate committee, “I think this is an area we can make a lot of progress.”

While pleased to hear Gottlieb speak in urgent terms about the opioid crisis—which in large part is responsible for overdoses now killing more Americans than shootings and car crashes combined—Democrats also used the issue to probe Gottlieb’s ties to the healthcare industry and whether he’d cave to political pressure from the Trump administration.

Sen. Tammy Baldwin (D-WI) brought up Gottlieb’s past advocacy for a “more holistic approach” to relieving chronic pain—using medical devices, perhaps—and that New Enterprise Associates, the VC firm where Gottlieb has worked for a decade, has invested in a company making devices for chronic pain. “What assurances can you give us that your business and financial relationships won’t bias you?” Baldwin asked.

Gottlieb, who has often used his position at conservative think tank American Enterprise Institute to pen op-eds about FDA matters such as sluggish drug approvals, generic drug rules, and off-label drug promotion, said he would do nothing to “besmirch” the agency. “I get it. I know why people care,” said Gottlieb. “FDA decisions are matters of life and death, and I don’t want to reduce confidence in the agency’s mission.”

Gottlieb has promised to recuse himself for one year from FDA decisions regarding companies linked to him, divest from about 20 companies, and to step down from all boards. Questions about financial ties and improper transactions swirled around Tom Price, the Health and Human Services secretary, who would be Gottlieb’s boss. The Senate confirmed Price in February largely along party lines.

Gottlieb said his industry experience helps him understand how companies try to “game the process”—use regulation to their commercial advantage—and that he would try to design better regulations to prevent egregious practices.

Gottlieb’s nomination has eased some fears in the life sciences world of drastic FDA upheaval because of his agency history and private sector experience. One potential candidate floated earlier by the administration had publicly questioned whether FDA needed to evaluate drugs for efficacy. Trump has declared he wants to cut FDA regulations by at least 75 percent.

The FDA saw plenty of reform in the Obama era, as well, with several new incentives to drug makers and new pathways to speed evaluation of drugs. The 21st Century Cures Act, signed by President Obama late last year, gives the agency even more leeway, which some critics considered an unacceptable loosening of standards.

While Gottlieb spoke often about streamlining regulations in today’s hearing, he did not speak about radical disruption. “I believe in the gold standard for safety and effectiveness,” he said. “That is something that needs to be demonstrated through an empiric regulatory process guided by the science and public health.”

But he acknowledged it will difficult to maintain high standards with fewer staff, which proposed White House budget cuts would impose. “I’m going to be committed to advocating for proper resources for the FDA,” he said. The administration has already imposed a hiring freeze. As experienced staff leave or retire, “replacing that kind of expertise and institutional knowledge is going to be a significant challenge,” Gottlieb said.

One Democrat questioned whether Gottlieb would also push back against political meddling over access to contraception, which FDA regulates. Gottlieb declined to discuss Bush-era FDA decisions about contraception, and said that as a physician, he would be guided by science, public health research, and the advice of the agency’s career staff.

The Senate Health, Education, Labor, and Pensions Committee will vote on Gottlieb after the upcoming Congressional recess, a spokeswoman said.

Ben Fidler contributed to this report.