In February, the Senate approved the nomination of Robert Califf, MD, to head the FDA, thwarting an effort by a group of senators to block his nomination over Califf’s ties to the pharmaceutical industry. MedPageToday article
I am very concerned about the leadership of the FDA and the FDA’s safety standards for new drugs and devices. Congress and the FDA have been too focused on getting medical products to market as quickly as possible, and not enough to testing them to make sure they are safe. In a New York Times article published on November 16, 2015, an editorial notes that “In 2014, Dr. Califf gave a speech to researchers, lawyers and industry experts in which he described regulation as a “barrier” to biomedical innovation.” I would like to know how the head of a regulatory agency could criticize regulations as being the problem rather than the solution. Besides the NYT, others have also questioned the appropriateness of appointing Dr. Califf to lead the FDA. His repeated funding over the years from many of the major pharmaceutical companies should result in questions from the Senators. In addition, a report from the Project on Government Oversight, last week noted that “He [Dr. Califf] helped lead a clinical trial that was sharply criticized by FDA reviewers.”
Dr. Robert Califf has countless ties to the pharmaceutical and medical device industries, representing significant conflicts of interest. The FDA needs to operate independently from industry in order to assure that drugs and devices are adequately tested for safety and efficacy before being released to the market. As it is, the approval pathways are already weak and broken. Under the proposals of the 21st Century Cures Act, the FDA has sought ways to align more closely with industry needs; setting aside safety and effectiveness in favor of innovation and speed. Adding Dr. Califf’s close associations with industry to the mix is a certain disaster for patient safety!
Boston Globe reports Dr. Califf removed his name from papers he had helped write, and the reasons are unclear. His actions beg the question as to whether or not he can he be trusted to pursue integrity rather than expediency?
It is the responsibility of the FDA to protect the health of Americans. The HELP committee is responsible for how the Food and Drug Administration operates, including the process for approving drugs and medical devices. Not surprisingly, committee members are some of the top recipients of health sector contributions.
The question everyone needs to ask is whether Dr. Califf’s ties to the industry are appropriate for the head of the FDA.