Sending a letter supporting the nomination of an FDA commissioner has been standard practice for CRN, executive director Steve Mister admitted. But he said Dr. Gottlieb’s qualifcations and his informed outlook on the agency and on the dietary supplement industry means his nomination is worthy of particular support. While some cabinet picks and nominations for federal agencies have raised eyebrows, many stakeholders in the dietary supplement industry believe the Trump administration got this one right.
“Dr. Gottlieb’s extensive medical experience, his background as a former FDA official and his understanding of various FDA-regulated industries make him an able and well-qualified candidate to lead the Agency. In addition, FDA needs a strong leader who understands the importance of fully implementing and enforcing the Dietary Supplement Health and Education Act (DSHEA) to ensure consumer safety and product integrity, while balancing those interests with maintaining consumer access to the wide range of these beneficial health and wellness products,” CRN’s letter states.
Mister noted Dr. Gottlieb’s positive response to a question posed in writing by Sen. Orrin Hatch, one of the original co-sponsors of DSHEA. It’s a question Sen. Hatch has asked prospective nominees for years, one that asks whether the nominee believes that DSHEA provides FDA adequate enforcement tools to regulate the supplement industry.
“If that were to have come back with a very different answer we might have very well sent a letter opposing his nomination,” Mister said. The Senate Committee on Health, Education, Labor, and Pensions voted 14-9 last week to send Dr. Gottlieb’s nomination on to the full Senate where it awaits a vote.
Pharma ties raise eyebrows
Dr. Gottlieb has not received universal support, something that can’t be expected in the current highly divided political climate. Dr. Gottlieb’s close ties to the pharmaceutical industry have been a stumbling block for some stakeholders in the arena of alternative health care. Dr. Gottlieb has served on the boards of pharmaceutical companies, including GlaxoSmithKline, and shortly after his nomination he received enthusiastic support from the Pharmaceutical Research and Manufacturers of America, a trade organization. Dr. Michael Caron, executive director of advocacy group Public Citizen, was quoted by CNN as saying Dr. Gottlieb’s ties to Big Pharma “go back years” and that history “has no doubt framed his thinking.”
Mister said CRN doesn’t buy in to the conspiracy theory-type thinking that might lead some to speculate that Dr. Gottlieb has a hidden agenda to boost drug companies. Mister said from CRN’s point of view, the nominee has a healthy view of FDA’s role, while at the same time casting a critical eye toward the end goals of regulation.
“I think we are going to see a number of Democrats oppose his confirmation because of some of his previous connections to the pharmaceutical industry. We think it is shortsighted to think that anyone who has worked within an industry is somehow disqualified from a regulatory role. We think they bring a richer understanding of the world they are supposed to regulate,”Mister said.
“I think he understands that the FDA has a really unique role in protecting public health. I think he will enforce the existing regulations that protect public health, but if there are duplicative regulations that are not really promoting a public health need, he might look to erase those. I don’t think the fringes of the industry should take any comfort in the idea that somehow because he was nominated by the Trump administration, he won’t enforce those laws,”he said.
Mister said the inauguration of the Supplement OWL label database is a significant step forward in making the case that the industry is making progress on the self regulation front. But he said an active FDA commissioner is key part of improving the industry and reining in bad actors.
“We can’t do it alone. We need a strong commissioner who will use the authority that Congress has given them,”he said.