Califf Faces Questions Over Ties to Industry at Confirmation Hearing

November 23, 2015

The majority of the Senate Committee on Health, Education, Labor and Pensions, from both sides of the aisle, expressed support for Robert Califf’s nomination as the next FDA commissioner last week.

HELP Committee Chairman Sen. Lamar Alexander (R–Tenn.) called Califf’s qualifications “impressive,” and Sen. Patty Murray (D–Wash.) said he is a “strong nominee” with an impressive resume and a longstanding commitment to transparency, and encouraged her colleagues to vote for him.

Interestingly, the sharpest criticism of President Barack Obama’s nomination came from his own party. Democratic presidential nominee Sen. Bernie Sanders (I-Vt.), who already has said he does not support Califf because of his cozy relationship with the pharmaceutical industry, prefaced his line of questioning with a statement of disapproval.

The senator repeatedly questioned why the FDA permits the importation of seafood from all over the world but will not allow the importation of lower-cost brand name drugs from countries like Canada. Califf said that the FDA has major concerns about reimported drug products and allowing them would incur huge costs to the agency.

Califf asserted that it is not the FDA’s job to set drug prices, but Sanders wouldn’t have it, saying that it is well within the agency’s jurisdiction. “We need a commissioner who is going to stand up to the pharmaceutical industry,” Sanders told Califf, “and I don’t believe that you are that person.”

Sen. Elizabeth Warren (D–Mass.) also had some tough questions for Califf — particularly over whether he would lower the standards for approval of drugs. Califf maintained that he is “not a proponent of lowering standards for anything.” This answer did not seem to satisfy Warren, who promised that she would not vote on his nomination until she read all of Duke University’s contracts with industry during his time there overseeing clinical trials.

Despite his nomination being widely praised by stakeholders, some groups — including Public Citizen — have questioned his closeness to industry because of the clinical trials he helped conduct.

Califf hammered home his trial program’s independence, saying that although some studies are funded by industry, “ironclad” contracts and international steering committees guaranteed the right to run trials freely. Industry could not influence the data or change what researchers said about trials, Califf added.

Califf also claimed that he donated any money he received as a consultant to nonprofit charities.

Sen. Bill Cassidy (R–La.) asked if greater advantage could be taken of compounding pharmacies to make drugs available more quickly instead of the generic route. For example, a generic of Turing’s Daraprim (pyrimethamine) — which has received negative attention because the drugmaker tried to drive up the decades-old product’s price — is years away; however, it has been made available for as low as $1 a pill through compounders, Cassidy said. Califf noted that this example can’t result in uniform change, as every drug is different, and the FDA is working hard on standards for compounders.

One avenue to drive down drug prices is seeking ways to lower clinical trial costs, Califf said. He added that the FDA is committed to working with industry and academia to develop a system that delivers better clinical trial results with a larger, more representative population, at a dramatically lower cost. That can be done, Califf said, by taking better advantage of electronic health records.

Labeling of biosimilars is also a high priority for the FDA, he told the committee. Labels should encourage their use, but they also should let patients and prescribers know that they’re different from the reference product. Labeling also needs to include global standards for nomenclature so that the products can be tracked in the marketplace, he said.

Finally, Califf opined that another regulatory pathway is needed for combination products, adding that within the next year, the FDA hopes it can present its opinions and work with Congress to develop the “right balance” for potential regulations.