Califf Debuts on Capitol Hill with Two Priorities

The Senate Appropriations subcommittee listened to Dr. Califf’s first testimony as FDA Commissioner this week. The hearing was very short, about 45 minutes, because of scheduled Senate votes. Appropriately, there was praise for Dr. Ostroff’s accomplishments as “acting,” but also a sincere welcome for Dr. Califf and the leadership he brings to the agency.In his opening remarks, Dr. Califf made clear that he had two priorities: building a strong, professional, well-supported FDA workforce; and strengthening science-based decision making at FDA. He mentioned four areas where new monies are going to be allocated: food safety, precision medicine, compounding, and antibiotic resistance.The questions asked by subcommittee members closely mirrored the House, only fewer of them because of the shortened session. Among the key issues were rice and arsenic; tobacco “deeming” regulations; voluntary GMO labeling; opioids; and FSMA implementation planning.Chairman Moran finished with three concerns: he would like to see a veterinary medicine practitioner become the new head of the Division of Veterinary Medicine; he wants the schedule for biosimilars rules and guidelines (requested by the 2015 omnibus appropriations bill); and he wanted more information on the recent GAO report on FDA’s IT plan. Had there been more time for the hearing, he mentioned that he would have asked more questions concerning Zika virus and the cancer “moonshot” effort.While it was a short session, you could tell that Members would have gone for a couple of hours if the time was available. Chairman Moran suggested that there might be a subsequent hearing sometime in the next few months because of the level of interest among subcommittee members.We think this is true of Congress generally: interest in FDA and FDA issues has never been higher. And while there have been a few angry voices, almost all of that interest seems to acknowledge that FDA has difficult issues to address and that the FDA is a problem-solving agency. Many, but not all Members of Congress accept that there are resource implications to FDA’s broad responsibilities and deep commitment to health and safety.Throughout the year, the Alliance is delivering messages to Congress about FDA’s mission and resource needs. So far this year, we have met with, and thanked, most of the Appropriations committee members. March 16, our Hill lobby day, is an opportunity to accelerate our efforts -- finishing off meetings with the appropriations committee members and expand outward to the authorizing committees and Congressional leadership. As the authorizers consider more responsibilities for FDA, it is important that resources be taken into consideration.Hill Day, March 16, is an opportunity for teams of Alliance members to deliver our messages to 50 or more offices in one day. We need your participation to make this happen. Please sign up by contacting Lynette Bechtel. If you can only do morning or afternoon, that’s fine. We can still use your help. Thank you.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.