Trade groups welcome Gottlieb's FDA confirmation
“CRN welcomes Dr. Scott Gottlieb’s confirmation to the post of Food and Drug Administration (FDA) Commissioner. His prior experience at the Agency, combined with his medical background and his understanding of industry, all bolster our confidence that he is well-qualified to lead the FDA. Dr. Gottlieb will bring the right balance of concern for consumer safety, focus on product integrity, and protection of consumer access to a wide array of dietary supplement products,” said Steve Mister, president and CEO of the Council for Responsible Nutrition.
“Dr. Gottlieb will ensure consumers have access to products that support their health and that businesses have the right to sell those products and grow the economy,”said Dan Fabricant, PhD, CEO and President of the Natural Products Association. “We congratulate Dr. Gottlieb on his confirmation and look forward to working with him in ways that lead to a healthier America.”
Dr. Gottlieb was confirmed by a 57-42 vote. While the dietary supplement industry was by and large enthusiastic about him, Dr. Gottlieb’s past ties were a stumbling for some stakeholders. In debate on his confirmation, Dr. Gottlieb’s finances were an issue, as Democratic senators cited government data showing he received hundreds of thousands of dollars in consulting or other fees from several FDA-regulated companies in recent years. Dr. Gottlieb has also worked with a venture capital firm and investment bank that also fund health companies.
Gottlieb has via an ethics documents filing promised to recuse himself for a 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.
On the Senate floor Tuesday, Sen. Ed Markey, D-MA, Dr. Gottlieb "would be nothing more than an agent of big pharma.”
One question that has plagued industry-FDA relations in the past is a perception that the agency has not always stepped up to the enforcement plate as vigorously as it could have. Both Mister and Fabricant noted that there are promising signs that Mister noted that Dr. Gottlieb publicly stated that he is a supplement user, and thus finds himself among the 71% of Americans who identify themselves as supplement users. Mister also said Dr. Gottlieb’s firm acknowledgement of the usefulness of the authority provided to FDA underthe Dietary Supplement Health and Education Act (DSHEA) is a promising sign. NPA noted that Gottlieb put into this into writing in answer to that question:
“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,” Dr. Gottlieb wrote.
