Natural Products Insider is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.


FDA Commissioner Nominee Clears Senate Hearing, Dodges Supplement Question

Dr. Robert Califf at Senate HELP confirmation hearing
<p>During the confirmation process, Sen. Orrin Hatch (R-Utah) asked nominee Robert Califf, M.D., about FDA&#8217;s dietary supplement regulatory authority, but Califf gave a vague answer.</p>

FDA Commissioner Nominee Robert Califf, M.D., easily won approval from the Senate HELP (Health, Education, Labor and Pensions) committee in a Jan. 12 voting session, but there is still no firm indication on how he views FDA’s authority to regulate dietary supplements. He has been only marginally more talkative on food issues. In contrast to most of President Obama’s other agency nominees, Califf’s overall reception was as non-contentious as widely expected, and final approval from the full Senate seems a certainty.

The executive session was mainly for voting, and Califf didn’t appear. The full confirmation hearing, including questioning of Califf by HELP members, was held back on Nov. 17, 2015, during which Sen. Orrin Hatch (R-Utah) opened his time by stating his general support of Califf’s confirmation, even calling the nominee “impressive." In fact, Hatch told Califf, “You deserve a lot of credit and will add a great deal to the FDA." Hatch spent all of his time asking about drug and lab testing issues, but asked one last question that would require only a yes or no answer.

“Do you believe as prior commissioners have—every one of them told me this— that the Dietary Supplement Health and Education Act (DSHEA) provides adequate authority to regulate the dietary supplement industry and protect consumers from unsafe products?" Califf responded, “We’re fully aware of our authorities, and you’re going to see a lot of action, where the authorities are pertinent, in the near future." Hatch asked again for a yes or no answer, but Califf issued a shorter version of his prior response.

The bulk of questioning during the hearing focused on non-supplement issues, including food safety, food labeling, drug pricing, tobacco regulation (e-cigarettes). However, there was some interesting discussion of delayed final guidance across the agency’s commodities.

Califf has an extensive background in drug research, having founded and directed Duke’s Clinical Research Institute, the largest academic research center in the world. A number of the trials conducted by his team were funded by drug and medical products companies. His primary detractors in this committee have been Sen. Elizabeth Warren (D-Massachusetts) and Sen. Bernie Sanders (D-Vermont). The senators expressed concern that Califf’s ties to drug companies would not be in the best interest of the American people.

Califf has said he is more about raising standards than lowering them, and he recused himself from dealing with certain drug companies that would represent a conflict of interest. He also fully disclosed financial information to the committee. 

In the Jan. 12 executive session, HELP Chairman Lamar Alexander (R-Texas) opened by issuing his support for Califf’s confirmation, saying the doctor had proven his ability to lead FDA . “I said at his confirmation hearing on Nov. 17, I’ve seen nothing that calls into question his ability to lead the agency fairly and impartially," he said.

Califf’s bipartisan appeal was reflected in remarks by the HELP Ranking Member Patty Murray (D-Washington), who lauded his “history of leadership and management record of advancing medical breakthroughs on challenging illnesses through clinical trials." She also noted his commitment to transparency, something FDA has struggled with under the Obama Administration. She praised his industry connections and said, “Dr. Califf’s record made it clear he will be a strong, independent FDA commissioner."

During this executive session, Warren finally issued her support, and the resultant vote to approve Califf for the next step was unanimous. Sanders had promised to vote against Califf and reported his intentions to vote by proxy while he is away on the presidential election campaign trail, but the vote was changed to a voice vote, which requires each senator on the panel to be there in person.

Califf will next face a vote by the full Senate, which is expected to approve his confirmation, but there are still potential roadblocks, including food labeling concerns.

Senators Raise Concerns Over Genetically Engineered Salmon, Other Food Issues

In issuing her approval to move Califf out of committee for a vote in the full Senate, HELP committee member Lisa Murkowski (R-Alaska) stated she still sought reassurances from Califf and FDA that they will develop mandatory labeling requirements for genetically engineered (GE) salmon. She noted how just two days after the November confirmation hearing, where she raised this issue with Califf, FDA moved to allow GE fish for human consumption for the first time ever.

“I was really taken back," she said, adding Califf was not direct with her despite knowing this issue is a priority for her and Alaskans. Murkowski said she was willing to delay her “hook" on the nomination, but she was clear on her demand that FDA and Califf reassure her that final guidelines will be developed on mandatory GE labeling of fish. “Voluntary guidelines are not sufficient and do not comply with the current law," the senator said.

Murkowski delayed the market entry of AquaAdvantage salmon by inserting language into the December 2015 federal spending bill that blocked the salmon from the U.S. market until FDA finalizes labeling guidelines. The salmon, produced by Massachusetts-based AquaBounty, was approved by the agency in November 2015 and has been a source of battle between environmental and food safety proponents and the salmon fishing industry.

In fact, a good deal of the committee’s confirmation concerns focused on food issues, including food safety. Sen. Barbara Mikulski (D-Maryland) called FDA a “national security agency," noting how the country’s food system is vulnerable to tampering. She further stressed the importance of the agency’s vigilance on fraudulent and defective products.

In the November hearing, Sen. Pat Roberts (R-Kansas) expressed his concern that farmers would face FSMA (Food Safety Modernization Act) regulations that overlap with existing regulations that apply to them. Califf said he’d be glad to work with Roberts and the Senate Agricultural Committee on this issue.

Sen. Tammy Baldwin (D-Wisconsin) brought up FDA’s recent proposals to update food nutrition labels with added sugar information, saying it might cause confusion for products such as cranberries that need added sugar to be palatable. “Should you be comparing cranberry juice to other fruit juices or soda pop? Should you be comparing dried cranberries to raisins or candy?"

Califf acknowledged the health benefits of cranberries, adding there frequently is cranberry juice in his fridge at home. “It is a good example of the balancing act FDA has to do," he said. “We have this terrible epidemic of obesity and diabetes, so huge amounts of sugar are clearly not good for you."

He said FDA needs to work on the cognitive psychology of labeling, so when the agency publicizes information it is easily understood and helps people make informed decisions. “Ultimately, it is up to people to make their own decisions, but if we don’t present it in the way that’s clear to them, it could lead to the wrong decision," he said.

The senators also raised issues concerning FDA’s guidance practices.

Sen. Richard Burr (R-North Carolina) said he hopes Califf will take seriously the mountains of outstanding guidelines on backorder at FDA. “Without guidance, I don’t know how the downstream effects are ever going to be felt of investment and development if, in fact, they don’t have the guidance to move forward," he said. Others on the HELP panel, such as Sen. Johnny Isakson (R-Georgia), also noted concerns that FDA is using guidance letters to avoid the cost-benefit analysis required by proper rulemaking. Califf made no comment on such overdue guidance.

Sen. Roberts asked Califf if the agency should set a maximum time that draft guidelines should be left without being finalized and if FDA should be required to publically respond to concerns submitted via public comment.

“I am a big advocate on transparency," Califf said, in response. “Every time we give people the opportunity to interact with FDA, they seem to want to do it more [often]." Califf suggested further discussions with the senators on the matter.

In the end, the support for Califf was clear, not just by the unanimous HELP panel vote for markup, but also in the jovial tone of the hearings—several senators joked with Califf about Duke and NCAA sports as well as other personal topics.

For more information on Califf and dietary supplements, check out the INSIDER article, “What Do We Know about FDA Commissioner Nominee Dr. Califf?"

TAGS: Regulatory
Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.