By Sheila Kaplan – Published November 22, 2016
WASHINGTON — Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration?
It’s been less than a year since Robert Califf was sworn in as the Food and Drug Administration’s chief, but already the agency is facing post-election upheaval. Public health advocates are bracing for a seismic shift: a surrender of the agency’s rules for off-label promotion of drugs; the importation of more drugs from other countries; and fewer requirements for clinical trials — long the gold standard for determining whether medicines are safe and effective.
“Between a Trump presidency and a radically pro-business Congress, the next few years may see a removal of numerous consumer protections,” said Michael Jacobson, co-founder and president of the Center for Science in the Public Interest.
For Trump and his advisers, including Newt Gingrich, the agency has for too long acted as a barrier to medical innovation.
Gingrich, the former speaker of the House, has previously described the FDA as the nation’s leading “job-killer” and called for its abolishment. “The FDA is a major prison guard stopping the breakout in health,” he wrote in the National Review in 2013.
The FDA’s balancing act between patient protection and the drug and device industry’s push for a quicker path to market has never been easy. But Califf, who had close ties to the pharmaceutical industry before his career at the FDA, has said there’s good reason.
“Unfortunately, too many of the decisions made today about health and health care are not supported by high-quality evidence, because there is such a limited amount available,” he said in a speech last May to the Food and Drug Law Institute.
“The current deficit in evidence has become particularly acute for the FDA, which in numerous areas lacks vital evidence needed to support definitive regulatory determinations of safety, efficacy, and appropriate indications for marketed medical products,” Califf told the group.