It was an hour and 57 minutes into the confirmation hearing for the next Food and Drug Administration commissioner before Scott Gottlieb drew a question about food.

Perhaps to be expected, it came from Sen. Pat Roberts, R-KS, who wanted to know if Gottlieb would favor setting some priorities for enforcement of the Food Safety Modernization Act (FSMA) and coordinate with the U.S. Department of Agriculture so that changes to nutrition labeling could occur at approximately the same time.

Roberts chairs the Senate Agriculture Committee.

Scott Gottlieb
Scott Gottlieb

Sen. Lisa Murkowski, R-AK, also had some questions about food for Gottlieb. With her constituents in Alaska still smarting from FDA’s 2015 approval of genetically modified salmon, Murkowski wanted to know if Gottlieb would re-visit the issue. She was critical of FDA for not only the approval, but for also deciding no special labeling is required for the product.

Gottlieb said he is willing to study the issue and work on it with Murkowski.

Murkowski also asked Gottlieb about FDA guidance issued in January, urging consumers to limit their in-take of certain fish because of mercury concerns. She said FDA did not take into account a “net value” study that shows people are better off eating more fish than less.

Gottlieb said he was willing to study that issue too, and work on it with Murkowski.

The confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions consumed two hours and 39 minutes. Chairman Lamar Alexander, R-TN, said additional written questions for Gottlieb must be turned in by Friday. The committee record will remain open for 10 days.

The “mark-up” session to send Gottlieb’s nomination to the full Senate for the confirmation vote won’t occur until the Senate returns from its spring break on April 24.

Alexander also announced Gottlieb’s nomination has the endorsement of Robert M. Califf and Margaret Hamburg, the FDA commissioners who served during the Obama Administration. He also said the committee has received seven letters with endorsements for Gottlieb from 29 professional organizations.

If confirmed, Gottlieb has agreed to resign from 13 boards and divest from about 20 different funds that are concentrated in pharmaceuticals and medical investments. Ethics officials have signed off on Gottlieb’s divestiture plan.

Several Democrats on the committee, especially Sen. Elizabeth Warren, D-MA, and Sen. Patty Murray, D-WA, spent much of their time picking apartment Gottlieb’s finances and his “big pharma” connections.

However, Republicans saw Gottlieb’s past experience with industries regulated by FDA as a plus, not a minus. Sen. Orin Hatch, R-UT, said he did not understand why Gottlieb is willing to give up so much to take the job, but that FDA will benefit greatly from the depth of his experience.

Gottlieb, a medical doctor and cancer survivor, was joined by his wife, daughters and his parents at the hearing. His father is also medical doctor. He served and was wounded in Vietnam.

Several times during the hearing, Gottlieb was asked what he would do if he was being opposed by the Trump White House. For example, FDA’s need to staff up to offset retirements in FSMA may be running counter to the administration’s hiring freeze. Gottlieb said he could be counted on to fight for what’s best for FDA.

Focus on opioid crisis
Much of the questioning was focused on the nation’s opioid crisis, including an exchange that began with Alexander asking Gottlieb about the promise of the 21st Century Cures Act and the possibility of developing non-addictive pain medicines in the near future.

“Dr. Collins, the head of the National Institutes of Health, has predicted a number of medical miracles over the next ten years. One of the most important would be the possibility of discovering non-addictive pain medicines which would make the opioid epidemic much less of a problem by providing a substitute,… ” Alexander said. “What could you do, as commissioner of the FDA, working with Dr. Collins, the president, and others in the administration, and with us, to be forward leaning on accelerating finding a discovery of non-addictive pain medicines, which might do more than anything to relieve the opioid epidemic?”

Gottlieb responded: “Thank you, Senator. The opioid epidemic in this country is having staggering human consequences. I think this is the biggest crisis facing the agency and is going to require dramatic action on the part of whoever steps into the agency. And I hope the Senate confirms me to take on this challenge.

“I think it’s going to require an all of the above  approach. I think there are some things that we’re going to have to do to really push the boundaries of the policy framework in this area, and that does include reevaluating the framework for how we can develop alternatives to opioid drugs. I think it also includes looking at the device alternatives to opioid drugs and looking at devices in the context of drugs, and I would also add to that, looking at medically assisted therapy to help people live a life of sobriety after they have become addicted.”

If confirmed, Gottlieb will return to FDA for a third time. He was there as associate commissioner during the administration of George W. Bush. Since his last stint, the opioid crisis has engulfed the U.S., including many rural areas. Gottlieb said the opioid crisis is a public health emergency as much as Ebola or AIDS and must be given the same degree of attention.


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