ASHINGTON — Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration?
It’s been less than a year since Dr. Robert Califf was sworn in as the FDA’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, cofounder 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.
Over the past few years, spurred by patient advocacy groups and much of the pharmaceutical industry, lawmakers have fought over a package of bills that would clear the path for a major shift in the way the country regulates prescription drugs and medical devices. Regardless of whether that legislation advances, Trump’s presidency is likely to enable the industry to get much of what it wants in terms of deregulation.
“I’ve talked to lots of folks in medical devices, pharma over the last several days. They are certainly, number one, breathing a sigh of relief,” said former Republican Representative Mike Ferguson, who is director of the federal policy at BakerHostetler and is close to the Trump transition team. “They were preparing themselves to have to go to battle with a Clinton administration that was very hostile to them.”
In a report to its clients, Holland & Knight, a law firm with a major health care practice, noted FDA staffers were particularly worried about the possibility that Trump would expand controversial “Right to Try” rules, which allow terminally ill patients to access unapproved therapies that have passed basic safety testing.
“At the very least, President-elect Trump will support ‘Right to Try’ laws that attempt to provide access to unapproved drugs,” the authors wrote. “Vice President-Elect Mike Pence supports a Right to Try law in Indiana as governor and advocated for it during the campaign.”
The FDA does have a program known as “compassionate use,” which grants access to unproven treatments outside of a randomized clinical trial. Although the agency grants nearly all such requests, it has also been wary about the “Right to Try” movement, which has been successful in 31 states, and leaves questions about whether the states have authority over the FDA — a prospect agency staffers do not welcome.
One former FDA official, who spoke on condition of anonymity to speak candidly, said support for the “Right to Try” movement signals a broader disapproval of regulation.
“The people who believe in that don’t believe there should be an FDA,” the former official said.
Trump has also vowed to remove barriers allowing easier entry into the United States for drugs made overseas — which would be difficult since the FDA is already having trouble monitoring the drugs that are coming in now.
Much of the FDA’s work, of course, focuses on food. Early on in the campaign, Trump expressed distain at FDA’s food safety regulations.
“The FDA Food Police, which dictate how the federal government expects farmers to produce fruits and vegetables, even dictates the nutritional value of dog food,” Trump said in a September speech. “The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperature and even what animals can roam which fields and when.”
Jacobson, of the Center for Science in the Public Interest, said “it’s hard to know how seriously to take it.”
But he also said Congress could easily cut the FDA’s budget, thereby “crippling programs to prevent food-borne infections, prevent dishonest food labels, and keep unsafe additives out of the food supply.”
Others said even if he intends to overhaul the FDA, Trump may be surprised to find there are limits to what he can do.
“You can be against regulation all you want, but the Food, Drug and Cosmetic Act is not something that is malleable within executive orders,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group, which has long battled the agency for better patient protection. “There are laws, many laws, and it took a long time to get them.”