The two-hour hearing before the Senate Health, Education, Labor and Pensions Committee was the first review of Califf’s credentials since his nomination. Sen. Elizabeth Warren (D-Mass.) said the significant pharmaceutical support he received over the years “naturally raises questions about your relationship” with the drug industry. “Your financial relationship with the industry also raises questions of what your priorities would be if you are confirmed with this job,” she said, asking whether Califf would sympathize with arguments that FDA is too stringent and needs to relax its standards in order to get promising treatments to market faster.
“I think if you look at my record, I’ve never been a proponent of lowering standards. If anything, I’ve argued for raising them,” Califf replied, while adding that the agency could move faster in some cases. “I think I’ve been staunch in that regard.”
Califf also said he had rejected roughly “70 percent” of potential collaborations with companies because they would not agree to certain conditions, such as giving researchers full access to clinical trial data and not censoring or demanding changes in findings. Warren said she would decide whether to support his confirmation after she reviews Duke’s clinical trial contracts with the drug industry.
Democratic presidential candidate and Vermont Sen. Bernie Sanders addressed skyrocketing drug prices — an issue that many Americans have identified as a serious economic concern — and said he doubted Califf would act to lower them. FDA, however, cannot currently consider a drug’s price when determining whether to approve it for market.
“At the end of the day, people are dying and not buying the food they need because they have to pay outrageous prices for medicine,” Sanders said. “We’ve been extraordinarily weak at taking on the pharmaceutical industry that has been ripping off the American people. I believe we need a commissioner who’s going to stand up to the pharmaceutical industry and protect American consumers. And I have to say to you, with regret, that I think you are not that person.”
Califf has faced scrutiny about his drug industry ties since President Obama tapped him for the top FDA post in September. A 2014 financial disclosure showed his salary at Duke was underwritten in part by large drug companies such as Eli Lilly, Novartis and Merck. He also has reported receiving speaking and consulting fees from a range of other pharmaceutical companies, though he has said he donates those fees to charity.
Earlier this month, the non-partisan watchdog group Project on Government Oversight detailed how Califf led one clinical trial that faced sharp criticism from FDA reviewers and outside advisors. Agency staffers found the trial, for the blood thinner Xarelto, was biased in favor of the unproven drug and that the trial’s design showed a “lack of care” that could have resulted in unnecessary strokes among some patients, according to one FDA official. Despite such misgivings, the agency approved the anti-clotting drug in late 2011 and has since expanded its indications for use.
For his part, Califf has insisted that such collaborations between academic researchers, patients, the government and the pharmaceutical industry are a necessary, if sometimes uncomfortable, reality of modern drug development. He reiterated that stance Tuesday.
“To advance, we must find common ground with industry and academia on the science without compromising [the] fundamental role of the FDA,” Califf said in opening remarks.
Despite the grilling from some Democrats about his ties to Big Pharma, Califf received a mostly warm reception on Capitol Hill. He vowed to try to speed up the process for generic drug approvals. He spoke about the need to combat antibiotic-resistant “superbugs,” to develop regulations governing laboratory-developed tests and to create ground rules for overseeing e-cigarettes and mobile health apps. At one point, he even answered questions about college basketball.
If confirmed by the Senate, as widely expected, Califf would inherit an FDA facing broad new responsibilities and confronting potentially major changes. Regulators are in the midst of implementing the most far-reaching overhaul in generations, as directed by Congress in a landmark 2010 law. The agency also has been wrestling with how to regulate the booming market for e-cigarettes, which so far have faced little oversight despite growing into a multibillion-dollar industry.
A bill currently working its way through Congress, known as the 21st Century Cures Act, also would mandate serious changes at the FDA under Califf’s tenure. The legislation, whose backers include an array of medical organizations, patient groups and members of both political parties, is aimed at streamlining the FDA’s approval process and speeding the development of lifesaving drugs and devices. But skeptics have expressed concerns that the effort could force the FDA to compromise its standards for safety and efficacy in the name of speed.
Many health groups welcomed Califf’s nomination, saying his decades of experience as a respected researcher, clinician and administrator make him an ideal fit to run FDA. The agency regulates not only food and drugs but also thousands of other products that Americans use on a daily basis, from sunscreen to infant formula to microwave ovens.
Nearly 70 organizations, from the American Heart Association to the Leukemia & Lymphoma Society, signed a letter sent this week urging Senate lawmakers to confirm Califf. It called him a “world expert” in clinical trial design and a skilled and “visionary” leader who can help FDA navigate the fast-changing world of modern medical innovation.
“[He] has acquired decades of real-world experience running and evaluating clinical trials,” the groups wrote. “He also maintains a deep understanding of the fast-moving science and the diverse stakeholders in government, academia, industry, and the patient community.”
Jeffrey M. Drazen, a Harvard Medical School professor and editor of the New England Journal of Medicine, wrote last month that lawmakers should confirm Califf “as soon as possible.” In part, he cited Califf’s experience, which includes publishing more than 1,200 peer-reviewed research articles. But he also noted that even when Califf has overseen clinical trials sponsored solely by the drug industry, he has relied on data above all else, often making recommendations that did not favor the companies involved.
“Given this performance,” Drazen wrote, “it is impossible to argue that Califf has a pro-industry bias.”