By Andrew Siddons, CQ Roll Call
November 17, 2015 -- President Barack Obama's nominee to lead the Food and Drug Administration (FDA) faced pointed questions about rising prescription drug prices and the pace of product reviews during a confirmation hearing that touched on the FDA's role in regulating products from medical devices to tobacco and genetically modified fish.
Duke University cardiologist Robert Califf, currently an FDA deputy commissioner, told the Senate Health, Education, Labor, and Pensions (HELP) Committee that the agency doesn't police the price of medicines but can influence cost by ensuring that products are safe and effective.
Califf faced sharp questioning from Bernard Sanders of Vermont, who is running for the Democratic presidential nomination and sponsoring several bills that would address drug prices through changes including allowing the importation of lower-priced drugs from Canada.
"We can import lettuce, tomatoes, vegetables from all over the world, but we cannot import from Canada prescription drugs," Sanders said. "Why do we pay the highest prices in the world, by far, for prescription drugs?"
Califf replied that he wasn't an expert on drug pricing.
"I'm certainly sensitive to the fact that in a field like cardiovascular medicine, my specialty, we need to have drugs available," Califf said.
Califf, echoing past concerns from FDA officials, said the agency would be stretched in trying to ensure that drugs imported from nations where they are sold for less were safe and effective. "We have major concerns about reimportation," Califf replied, saying that a system to monitor the imports would need to be developed and funded properly.
Sanders has previously said he would not support Califf's nomination and reiterated his position.
"I believe we need a commissioner who is going to stand up the pharmaceutical industry, and protect the American consumer, and I have to say to you, with regret, that I think you are not that person," Sanders said.
In opposing Califf, Sanders appears to be in the minority of senators on the HELP panel. The committee's top Democrat, Patty Murray of Washington, expressed support for his nomination, as did Richard Burr, R-N.C., and Barbara Mikulski, D-Md.
HELP Committee Chairman Lamar Alexander, R-Tenn., suggested through his questions that it is not the FDA's job to worry about the price of drugs.
"Do you believe in terms of drugs, it's accurate to say the FDA's statutory mission is to promptly and efficiently make sure that drugs are safe and effective?" Alexander asked.
"That is our primary mission, but we also can have an impact on the cost of drugs by performing that function effectively," Califf responded.
Califf's ties to pharmaceutical companies were raised by some Democrats. Califf previously ran Duke's Clinical Trial Research Institute. Some believe that the work he did with pharmaceutical companies could bias his decisions as a regulator of those same firms.
Murray and Sen. Elizabeth Warren, D-Mass., asked Califf if these relationships should be a concern. Califf told Murray that while at Duke, if a study was funded by industry, the company would sign "an ironclad contract" guaranteeing the independence of the researchers.
Warren asked Califf if he agreed with the pharmaceutical industry that the FDA is "too tough," and that standards should be lowered.
"I've never been a proponent of lowering standards. If anything, I've argued for raising standards for better studies that show the full gamut of risk and benefit," Califf replied. "That doesn't mean we couldn't potentially be quicker."
Alexander said in his opening statement that Califf had accepted "several recusals" for unspecified issues recommended by the Office of Government Ethics. That office and committee staff had found no remaining conflicts.
Alexander pressed Califf on the FDA's logjam of generic drug applications, and why, despite a $1 billion in funding from a generic drug user fee authorized in 2012, the review time for generics had slipped from 30 months to 48 months.
Califf explained that the accumulation developed before the new funding, and it takes time to clear through that. "As that backlog is cleared, the new applications will be going through very quickly," he said.
The panel has not said when it will vote on Califf's nomination. Ben Sasse, R-Neb., has separately put a hold on all of Obama's health nominees until he receives answers about the failure of nonprofit health co-ops created under the health care overhaul.
