Califf Wins Approval to Lead FDA, Hatch Voted for Confirmation

Updated 2/25/2016, 12:30pm.

Cardiologist Robert Califf, M.D., is the newly approved FDA Commissioner, finally filling the agency’s top position vacated by Margaret Hamburg, M.D., last February. After voting Monday Feb. 22 to close debate on Califf’s nomination, the chamber today voted 89-4 to approve the new Commissioner.

Califf, a former Duke University clinical researcher, has most recently served as deputy commissioner of tobacco and medical products at FDA (effectively number two behind Acting FDA Commissioner Stephen Ostroff, M.D.). Where Hamburg brought extensive public health experience, Califf’s background is dominated by planning and conducting drug clinical trials. It is this experience that presented the primary opposition to his nomination, as several Senators expressed concern that his ties to the pharmaceutical industry could be a conflict of interest for a leader of FDA.

The only four Senators to dissent were Richard Blumenthal (D-Connecticut), Joe Manchin (D-WV), Edward Markey (D-Massachussetts) and Kelly Ayotte (R-New Hampshire). For all his earlier objections to Califf’s nomination, presidential candidate Sen. Bernie Sanders did not submit a vote.

His experience with and attitudes towards dietary supplements are less clear. However, this did not stop supplement-supporting senators including Sens. Orrin Hatch (R-Utah), Martin Heinrich (D-New Mexico) and Mike Enzi (R-Wyoming) from voting in favor of Califf’s confirmation.

An extensive hearing was held in November 2015, at which Califf responded to questions and concerns from Senate HELP (health, Education, Labor and Pensions) Committee members. During the hearing, Sen. Orrin Hatch (R-Utah) asked Califf if he believes FDA has sufficient authority under DSHEA (Dietary Supplement Health and Education Act) to adequately regulate the dietary supplement industry. Califf mostly dodged the question by stating his awareness of the agency’s authorities without indicating his specific position on supplement regulation.

However, Hatch ultimately voted in support of Califf’s confirmation, both in committee and on the floor this week. Hatch, a staunch supporter of consumer access to dietary supplements and co-author of DSHEA, said he voted for Califf’s confirmation because he trusts the new commissioner, via the newly elevated Office of Dietary Supplement Programs will properly enforce DSHEA and issue guidance.

“I supported his confirmation today because I trust that he will continue to share with the Senate his plans to address bad actors in the dietary supplements industry and return to the process of issuing guidance to open-comment rule-making," Hatch said, in a statement. “In the past, questions on dietary supplement regulation have been met with hesitancy and uncertainty. I look forward to Dr. Califf using the authorities under DSHEA in a transparent way to coordinate with the [Department of Justice] to protect consumers from unsafe products without condemning the entire market."

In his statement, Hatch reiterated his belief FDA has sufficient authority to issue rulemaking on dietary supplements and other areas in its jurisdiction. One of Hatch’s concerns, echoed by many of his HELP colleagues, is FDA’s recent tendency to issue non-binding guidance instead of open-comment rulemaking. “When the FDA holds companies accountable to decisions released in non-binding guidance, it creates unnecessary confusion in the market that has a tangible effect on innovation," his statement explained. Instead, Hatch encouraged Califf and FDA to engage stakeholders and determine the most appropriate practices in product development and approval.

The Council for Responsible Nutrition (CRN) issued its support for Califf’s confirmation. “Dr. Robert Califf’s Senate confirmation as FDA Commissioner is pivotal for the agency, as well as for the dietary supplement and functional food industry,” said Steve Mister, president and CEO of CRN. “Based on his confirmation hearing, we feel confident that Dr. Califf will be fully committed to enforcing the laws and regulations for our industry that help protect consumers. Further, we hope the Commissioner will continue the agency’s recent enforcement actions taken in conjunction with the Department of Justice to help rid the marketplace of the most egregious companies defaming our industry and posing the highest risk to consumers. Dr. Califf’s demonstrated leadership at the agency, paired with the recent elevation of the Division of Dietary Supplement Programs to ‘Office’ status, will enhance the agency’s ability to fulfill its regulatory responsibilities. As our industry continues to grow and evolve, we look forward to having a strong leader in place and working with Dr. Califf and his team on public health issues.” 

Immediately following the confirmation, the Natural Products Association (NPA) sent Califf a letter congratulating him and requesting a meeting to go over several FDA priorities outlined in the letter.  NPA asked Califf to clarify his plans for using the agency’s legal tools and authorities to enforce existing dietary supplement laws and regulations. NPA asked Califf to consider the agency’s mandatory recall authority, administrative detentions and the use of seizures over injunctions to better curtail adulteration and misbranding.

The trade group specifically highlighted FDA collaboration with DOJ to bring misdemeanor cases against small fly-by-night companies selling adulterated or misbranded supplements, noting such actions could serve as a deterrent to other would-be bad actors. NPA also suggested FDA increase efforts to identify unsafe ingredients and remove them from market using the 402(f)(1)(B) charge—from the Food Drug and Cosmetic Act, a new dietary ingredient with inadequate evidence to prove it does not present unreasonable risk of illness or injury.

“NPA also strongly supported the elevation of the Division of Dietary Supplements at FDA to an Office,” said Fabricant, Ph.D., executive director and CEO of NPA. “This is a long overdue step within FDA that we hope will empower the [Office of Dietary Supplements] to exercise all the authorities it has to regulate this important industry. To that end, we are interested knowing when a strategic plan for the new office of dietary supplements will be developed and what the FDA anticipates its budget will be for FY 17.”

Loren Israelsen, president of the United Natural Products Alliance (UNPA), also congratulated Califf on his confirmation and echoed Sen. Hatch’s expectations for dietary supplement regulation moving forward.

“We share Sen. Hatch's hope that Dr. Califf will, working with the newly elevated FDA Office of Dietary Supplement Programs, use the substantial array of authority the agency has under the Dietary Supplement Health and Education Act to protect and preserve consumer access to safe and beneficial dietary supplements,” Israelsen said. “We have been most encouraged by recent FDA efforts to identify and to then take action against clear violations of the law. We have also been encouraged by recent FDA statements in support of the positive steps taken by companies and industry to provide Americans high quality products while ensuring consumer safety. UNPA’s ongoing series of supplement quality summits, including the just completed Raw Materials & Supply Chain Summit, are just the most recent examples of industry’s commitment to exactly those principles.”