President Barack Obama’s nominee to lead the Food and Drug Administration moved successfully through a senate committee vote on Tuesday, January 12, only to face a couple of potential obstacles.
The Senate Committee on Health, Education, Labor, and Pensions voted almost unanimously on Tuesday to move Dr. Robert Califf’s nomination through to a full senate vote. And although Senator Lisa Murkowski (R-Alaska) voted for him at the hearing, she said she would hold the vote from reaching the senate floor if Califf does not clearly state his stance on mandatory labeling for genetically engineered (GE) salmon.
According to The Washington Post, Presidential candidate senator Bernie Sanders has also been outspoken in his opposition for Califf. He was absent from the hearing but voted against the nominee by proxy.
“We need a leader at the FDA who is prepared to stand up to the drug companies. We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada, and hold companies accountable who defraud our government. Dr. Califf is not that person,” Sanders said in a statement.
Califf left his research position at Duke University in February 2015 to take the number two spot at the FDA as Deputy Commissioner for Medical Products and Tobacco. The renowned cardiologist and researcher had worked at Duke for three decades.
In a report from last year, Medpage Today wrote:
“Traditionally a deputy does not move up to the commissioner’s office, but the reasoning goes like this: Califf would not have given up a powerful position at Duke unless he had inside knowledge of Hamburg’s impending resignation.
Moreover, Califf, who is a frequent witness at congressional hearings, does have friends on both sides of the aisle, so his confirmation process might be relatively bloodless.”
If Califf becomes the next FDA commissioner he will likely only hold the position for a year, until a new president and new administration come into power in 2017.
The next step is a full senate vote
Murkowski said Tuesday that she was hot under the collar since Califf had not notified the HELP committee members at the November 17 hearing that genetically engineered salmon would be approved for human consumption. She had asked Califf at the hearing if he would help her with labeling requirements for Russian Pollock if he took the top spot at the FDA. Russian Pollock was often labeled as sourced in Alaska, she said.
“It was two days, Mr. Chairman, two days before the FDA made its announcement that they were going to move forward with allowing genetically engineered fish for the first time for human consumption, and I have to admit I was really taken aback that he was not direct with me,” she said before the HELP committee on January 12, adding, “He clearly knows that that was a priority of Alaskans, and certainly of this senator.”
In a press release, Murkowski wrote:
In today’s HELP committee executive session, Senator Murkowski voted to move Dr. Califf’s nomination forward to be considered by the full Senate, saying:
“Dr. Califf’s nomination hearing was just 2 days before the FDA made its announcement that they were going to move forward with allowing genetically engineered fish for the first time for human consumption. I have to admit I was really taken aback that he was not direct with me. He clearly knows that’s a priority of Alaskans, and certainly this Senator. I said at that time I need to have an understanding of where the FDA is going on this issue, and I would put a hold on his nomination as it moves forward. We cannot put a hold on anybody until they have moved out of committee. That’s what we’re doing here today.
“What I would like to make clear to my colleagues is that we have attempted to address some of the issues that I have raised through the appropriations bill that we moved forward in December. We included language that would require the FDA to not allow the introduction into interstate commerce of any product containing genetically engineered salmon until the FDA publishes final labeling guidelines. I want the assurances that in fact is what is going to happen. I want to make sure that the FDA knows that voluntary labeling guidelines really are not sufficient.
“It does not comply with what is now law. I want to make sure, be very, very certain, that when we are talking about these genetically engineered fish for human consumption, voluntary labeling is not adequate. So I’m going to be pushing for further conversations with Dr. Califf on this. I will vote to move him out of committee today, but I just want my friends and colleagues to be on notice that I have these concerns, and I would like to get them resolved before his name moves forward to the Senate floor.”
The FDA approval of the GE salmon had allowed AquaBounty, the company that engineered the salmon, the freedom to decide whether it would disclose to its consumers that they were buying GE fish. The product could have been in supermarket seafood departments as early as the end of next year. But Murowski and her colleagues had some language added into the omnibus bill published in December that required the FDA to prepare labeling guidelines for the GE salmon before it can be sold.
Senator Patty Murray (D-Washington) echoed the concerns of her colleague at Tuesday’s hearing. “She raises real concerns,” Murray said, adding, “I’m glad we got the language in the omnibus, but I want to work with you on this moving forward. It is a huge concern.”
Chairman of the HELP committee, Lamar Alexander, asked that the senators have their discussions with Califf as soon as possible, “because of the size of the responsibility that he has at FDA, we need an impressive leader in an affirmed position there.”
The FDA has been without a leader since the end of March 2015, when Margaret Hamburg resigned for reasons that have been kept out of the media. Dr. Stephen Ostroff, the FDA’s chief scientist, is the FDA’s acting commissioner.
Bernie Sanders opposition to Califf
Bernie Sanders may also hold the vote on Califf’s appointment from reaching the senate floor.
According to Reuters, Sanders said in a statement:
“His extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than pharmaceutical industry CEOs who are more focused on making obscene profits than saving lives.”
During the hearing. the HELP committee senators had questioned Califf on his views on key health, pharmaceutical, and food safety issues. A number of senators, including Senator Elizabeth Warren (D-Massachusetts), aired concerns about potential conflicts of interest given his relationship with the pharmaceutical industry.
Warren requested copies of contracts between Duke University and its pharmaceutical clients to understand the working relationships. Duke University had agreed to release the contracts.
Researched by SARAH MATHESON