FDA nominee strongly affirms DSHEA during hearing
Dr. Scott Gottlieb, MD, is President Donald Trump’s pick to head the Food and Drug Administration. Dr. Gottlieb, who is among other things a cancer survivor and a professor at the New York University School of Medicine. He has also been a health care analyst at an investment firm and has close ties to the pharmaceutical industry, having served as a board member for Glaxo Smith Kline. Dr. Gottlieb has served as senior policy adviser to the Administrator at the Centers for Medicare & Medicaid Services and has been a regular contributor to the Wall Street Journal.
Nominee admits to using supplements
Daniel Fabricant, PhD, executive director of the Natural Products Association, (which supplied the news of Gottlieb’s confirmation hearing this morning), said Gottlieb’s answer to a question by Sen. Orrin Hatch, R-UT, was a welcome revelation as to how he sees the dietary supplement industry and bodes well for the future.
Sen. Hatch, who along with former Sen. Tom Harkin, D-IA helped usher in the Dietary Supplement Health and Education Act in 1994, has for years asked every prospective nominee for FDA commissioner more or less the same question about how the nominee views the powers granted to FDA under the DSHEA. In a question for the record submitted in connection with Dr. Gottlieb’s confirmation hearing before the United States Senate Committee on Health, Energy, Labor, and Pensions the exchange went like this:
Sen. Hatch: "Every day, millions of Americans safely take one or more dietary supplements. As consumers continue to take greater control of their health, it is important that they have access to safe products that fit their needs. The FDA currently has the oversight authority to remove any product it finds is unsafe and to take enforcement action to remove the product from the market. Dr. Gottlieb, do you believe the FDA’s current regulatory framework under DSHEA provides for adequate enforcement tools to remove unsafe dietary supplements from the market?"
Dr. Gottlieb: "As someone who uses dietary supplements every day, I believe they serve an important role in health promotion for millions of Americans and I support consumer access to these products. I believe the regulatory framework established under DSHEA is the right one, and if confirmed, I would commit to enforcing DSHEA, as intended by Congress."
Other nominees have been more circumspect
Gottlieb’s answer to Sen. Hatch’s boilerplate question was more forthright and enthusiastic than how previous nominees have generally responded, Fabricant said.
“It sounds as if we have a more receptive ear at the agency than certainly we had during the prior administration,” Fabricant told NutraIngredients-USA. “It’s obvious in the way Dr. Gottlieb answered the question that he has great respect for Sen. Hatch. Generally the answer of previous nominees has been much less personal, much more metered.”
FDA, like all other federal regulatory agencies, is staffed with career bureaucrats who carry certain modes of thinking from administration through administration. Nevertheless, a new commissioner has a big role in setting the tone, and Dr. Gottlieb’s tenure looks promising, Fabricant said. He said he believes Dr. Gottlieb won’t have much trouble getting confirmed, and NPA is sending a letter to lawmakers later today supporting his confirmation.
Guarding against complacency
Fabricant said that the danger with a nominee like Dr. Gottlieb is that some stakeholders in industry might tend to relax their vigilance. Problem solved, in other words.
“The problem could be with some apathy setting in. Now is the time to get on the horse and ride. We think the trade associations can play a huge role getting involved. The hope is that we’ll have an agency that will have less of a defensive posture and will be more willing to get involved to see how we can help Americans save money on their health dollar,”he said.
