Senate Panel Clears Califf; 'Cures' Bill Ahead

As expected, Robert Califf got a thumbs up on Jan. 12 from the Senate Health, Education, Labor and Pensions (HELP) Committee to take the reins of the FDA.

But one senator has threatened to place a hold on Califf's nomination before it goes to the full chamber if she is not satisfied on what the agency plans to require for labeling of genetically engineered (GE) salmon – often referred to as "Frankenfish."

The HELP panel chairman, Lamar Alexander (R-TN), however, made it clear he wants to get any disputes over the GE salmon or other issues over and done with so the FDA nomination can go to the full Senate as soon as possible and the committee can move on with its work of completing its draft of legislation aimed at overhauling the US biomedical enterprise, which is expected to have broad implications for the food, drug and device agency, as well as the National Institutes of Health (NIH).

Sen. Lisa Murkowski (R-AK) said she was "hot under the collar" and "really taken aback" because Califf was "not direct with me" about how the FDA planned to move forward on the GE salmon – declaring she had pressed him on the matter just two days before regulators made their decision this past November to allow AquaBounty Technologies Inc. to market its AquaAdvantage salmon.

Murkowski officially could not place a hold on Califf's nomination until the HELP Committed had taken a vote.

She noted lawmakers had included a measure in the recently enacted Omnibus spending bill, which provided the FDA a $133m increase for fiscal year 2016, to require the agency to publish labeling guidelines before the GE salmon can be introduced into interstate commerce.

"I want assurances that is, in fact, what is going to happen," Murkowski said, insisting voluntary labeling would not be adequate.

"I'm going to be pushing for further conversations with Dr. Califf on this," she said.

Sen. Patty Murray (D-WA), the ranking member on the HELP Committee, said she also felt strongly about the matter, calling it a "huge concern."

While Murray confirmed her support for Califf, she also raised the issue of ensuring the FDA "always places science over politics."

She also made a point of emphasizing there's "much more we can do to bring patients' voices into the process of developing new treatments and cures, so that their priorities are consistently being reflected."

Drug Prices Comes Up

Sen. Sheldon Whitehouse (D-RI) used the hearing as an opportunity to again voice his concerns over drug companies that have significantly jacked up the costs of their medicines – declaring that "it's hard to talk about the FDA and pharmaceuticals without mentioning this pricing hiking."

"In addition to watching the pharmaceutical develop new drugs, which we encourage, we've also watched the pharmaceutical industry develop new drug pricing models, which appear to be in many cases to find a monopoly opportunity, buy in, raise prices and extract monopoly rents," Whitehouse asserted.

Whitehouse said, however, he "strongly" supported Califf.

Sen. Barbara Mikulski (D-MD) said she was "glad" Califf was "willing to serve in the last year of the Obama administration," given it's unclear whether the next US president will keep him on or promptly replace him.

"Dr. Califf has the right stuff," Mikulski argued.

The vocal opposition to Califf that had expected to have been raised during the Jan. 12 hearing by two senators – Sens. Elizabeth Warren (D-MA) and Bernie Sanders – didn't happen.

Warren instead remained mum, other than saying she was submitting a written statement, and Sanders, who is running for US president, was out on the campaign trail.

But in her statement, which was provided to Scrip, Warren said that after having multiple meetings with Califf and "extensive" conversations with him and consulting outside experts, the Massachusetts lawmaker said she was "satisfied" the candidate had "conducted himself with integrity as an academic researcher."

"I am satisfied that he can be a strong leader for the FDA, placing the interests of patients and the American public above all others," Warren wrote.

Sanders, however, already has declared he plans to vote against Califf when his nomination comes before the full Senate.

Alexander said he hoped any further conversations the HELP panel members want to have with Califf could be done in a "speedy" manner.

"We need an impressive leader in a confirmed position," he insisted.

Since this past September, when President Barack Obama nominated Califf, who currently serves as the FDA's deputy commissioner for medical products and tobacco, Alexander said he and his staff had "carefully reviewed" the candidate's submissions and qualifications – pointing out the nominee has "undergone extensive vetting" by the White House and has submitted detailed financial information, answered 37 pages of questions from the HELP Committee, submitted thousands of pages on articles and lectures for its review, testified before the panel in November and provided over 100 pages of responses to written questions.

"I've seen nothing that calls into question his ability to lead the agency fairly and impartially," Alexander said. "He has impressive qualifications. He's a leading cardiologist, [was] a professor at one of the nation's top medical schools, an expert in clinical research and recognized author of medical publications. He has managed large organizations and was the founding director of Duke's Clinical Research Institute."

"I have concluded that Dr. Califf is the right person to lead the FDA," Alexander declared.

Status Of Senate Biomedical Bill

The Tennessee lawmaker argued it is "vital that we have the right person leading" an agency that affects the lives of nearly every single American and regulates about a quarter of all consumer spending in the US – over $4 trillion annually.

"It's especially vital at this time when we have such exciting science going on, providing more opportunities for treatments and devices that will improve the health of Americans – a subject that this committee, on both sides of the aisle, is working very hard on," Alexander said, referring to the Senate's companion bill to the House 21st Century Cures Act, which was adopted last July.

"We've worked very well on that this past year," he said, adding that the HELP staff "in a bipartisan way" has developed about "three dozen pieces of legislation, which have significant Democratic as well as Republican support."

The HELP chairman said he's been in discussions with Murray about how to move the Senate bill forward – a draft that was promised to be out this past fall, but a vow that was not kept.

"The president is very interested in precision medicine. There's never been a more exciting time in science than we have today," Alexander said, adding the NIH has "an especially competent person" to lead it in Francis Collins, so "we should finish our work on this bill."

"I'm committed to doing it in a bipartisan way that allows amendments and everyone to offer what they'd like to offer and doing it in a way that works toward a result," Alexander said.

He noted that even though the HELP Committee has a full agenda to accomplish, he thinks the panel can get the Cures companion bill done this year, despite the 2016 presidential and congressional elections.