Lawmakers took little time moving forward on the White House's choice to run the U.S. Food and Drug Administration, despite the objections of one senator.
Members of the Senate Health, Education, Labor and Pensions Committee voted unanimously Tuesday in favor of sending Dr. Robert Califf's nomination to the full Senate.
Sen. Lisa Murkowski said she will hold up a vote on the Senate floor until she has reassurances from the agency that genetically modified salmon will be labeled. The Alaska Republican has said the labeling guidelines on engineered salmon approved by the agency last year could harm her state's wild salmon industry.
Absent from the proceedings were the criticisms and questions that arose after Califf was first nominated to be the next FDA Commissioner. Califf is now the second in command at the agency that regulates consumer products from medications to seafood to e-cigarettes. He was a prominent cardiologist and medical researcher at Duke University for more than 30 years. But critics question Califf's financial ties to pharmaceutical firms while serving as director of the Duke Clinical Research Institute.
Among those who see the relationship as a red flag is Democratic presidential nominee Sen. Bernie Sanders (I-Vt.). He said he would vote “no” to Califf's nomination, believing he could not remain impartial.
“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices,” Sanders has said.
Califf's nomination does have the support of the Republican chairman of the Health, Education, Labor and Pensions Committee, which approved the nomination by voice vote. Sen. Lamar Alexander of Tennessee said that Califf has been thoroughly vetted and that Califf can lead the agency "fairly and impartially."
As head of the FDA, Califf would inherit a raft of projects and potential challenges, including unfinished tobacco regulations and food safety and labeling reforms.
Califf has served as the FDA deputy commissioner for Medical Products and Tobacco since last January. He was nominated by the Obama administration in September to replace Dr. Margaret Hamburg, who stepped down in March after six years in the role. His nomination has the support of industry trade groups such as the Biotechnology Industry Organization and the Generic Pharmaceutical Association, citing as a plus his expertise in clinical research.
During a confirmation held in November, Califf said a priority as commissioner would be to streamline the clinical trial process to increase efficiency and lower costs. He also would create a post-market surveillance system for medical devices that mirrors the one in place for drugs. When asked whether he was in favor of lowering regulatory review standards to expedite approval of new products, Califf said he was for a faster, more efficient approval that did not lower standards.
“Americans depend on safe drugs and devices that are also effective,” Califf said. “A drug or device that is safe but not effective actually can harm someone because then they don't use what can be effective–I think I have been staunch in that regard.”
