Facing members of the Senate’s Committee on Health, Education, Labor and Pensions last week, Robert Califf, President Barack Obama’s choice to head the FDA, defended his record, emphasizing he would not lower standards for device approvals.
Many Committee members had great praise for Califf. HELP Committee Chairman Sen. Lamar Alexander (R-Tenn.) called his qualifications “impressive,” and Sen. Patty Murray (D-Wash.) said he is a “strong nominee” with an impressive resume and a longstanding commitment to transparency. She encouraged her colleagues to vote for him.
However, not all members were impressed, with the sharpest criticism coming from Democratic presidential nominee Sen. Bernie Sanders (I-Vt.).
The senator already has said he does not support Califf because of his cozy relationship with industry and prefaced his line of questioning with a statement of disapproval.
Sen. Elizabeth Warren (D-Mass.) also had some tough questions for Califf — particularly over whether he would lower the standards for approval of drugs and devices.
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.
Califf also claimed that he donated any money he received as a consultant to nonprofit charities.
He also told the committee that he is working closely with CDER head Janet Woodcock to create a template across the FDA to make sure that medical device and drug standards are similar.
Sen. Sheldon Whitehouse (D-R.I.) asked Califf if greater FDA oversight was needed for medical apps. Califf said that the agency fully intends to regulate apps, depending on their risk.
A health-related app that counts calories or steps likely wouldn’t be regulated, he said, as the agency doesn’t want to waste its time. However, an app that connects to a defibrillator or a glucose monitor, for example, needs to be looked into.
“Apps will need to be regulated,” he said, and that even something as simple as a heart rate monitoring app may be used differently by a heart failure patient, and it could have a greater effect on him or her.
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. — Kellen Owings