President-elect Trump didn’t talk a lot about the Food and Drug Administration while he was on the campaign trail, but judging from what he did say, he will want the FDA to approve new drugs and products much faster.
However, experts and agency veterans say that Trump will get pushback from career staff at the FDA if he tries to go too far.
Trump has yet to announce his pick for whom to lead the agency and succeed Commissioner Robert Califf, a former Duke University researcher. Trump did not mention the FDA in his plan for his first 100 days in office.
“There are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications,” Trump said during a speech in Gettysburg, Pa., in October.
Trump’s impact on the FDA, which regulates not only drugs but also food safety and medical devices, will extend far beyond speeding up medication approvals, some experts and advocates say.
“The overall flavor coming from the administration will be one to push products through,” said Michael Gaba, a partner in the life sciences practice for law firm Holland & Knight.
However, which products get a boost could create some tension in the pharmaceutical industry, which has complained that the approval process is bureaucratic and hurts competition.
Over the past several years, the FDA has taken high-profile moves to speed up approval of certain products. But when it comes to speedy approval, not all products are created equally.
For instance, “orphan” drugs that treat rare disorders receive accelerated approval, as do breakthrough products that are better than products already on the market.
One such orphan drug is Kalydeco, the first treatment for the genetic disorder cystic fibrosis. Keytruda, a lung cancer treatment, is a breakthrough drug that was approved because it worked better than products on the market.
“There are elements of regulated industry that want everybody to be regulated the same,” Gaba said.
While speeding up drug approvals has bipartisan support, the Trump administration could go further by relaxing “some standards to facilitate the speed,” Gaba said.
The consumer advocacy group Public Citizen is especially concerned about whether Trump will weaken FDA standards based on language on the president-elect’s transition website, including that the agency needs to put patients first and be more streamlined and innovative.
“This language signals a troubling deregulatory approach that would weaken further the FDA’s standards for ensuring that drugs and medical devices are safe and effective,” said Michael A. Carome, director of health research for Public Citizen.
Any effort to relax approval standards could prompt pushback from career agency staff who review the products, Gaba said.
“That is a tension we should try to anticipate, and whether there will be success in relaxing standards in some way to speed approvals remains to be seen,” he said.
An agency veteran said the FDA isn’t a “political agency” and that there aren’t many political appointees at the FDA.
“The job of the commissioner and the political appointees is to have a vision and sell it to the career staff,” said Peter Pitts, a former associate commissioner at the FDA and the president and CEO of the Center for Medicine in the Public Interest.
Pitts gave an example of Margaret Hamburg, who was the commissioner under the Obama administration before retiring.
Hamburg pushed back against President Obama and then-Health and Human Services Head Kathleen Sebellius’ efforts to make the Plan B birth control pill an over-the-counter product.
“She made a big point where she wasn’t going to be overriden,” Pitts said. “That sent a signal to staff that they were respected by the commissioner.”
Pitts added that Trump’s pick to helm HHS, Georgia Rep. Tom Price, understands how the dynamic at the agency works.
“The FDA is an ally in bringing drugs for serious diseases faster [to market],” Pitts said.
Approval standards aren’t the only things that could be under scrutiny with a Trump administration.
Gaba referred to several “gray areas” of enforcement for cosmetic, food and dietary supplement products.
The agency doesn’t approve dietary supplements before they reach the market, but can pull products if they don’t meet health standards. For instance, the agency typically pulls weight-loss supplements off the shelf due to undeclared ingredients.
Another area of leniency could be false health claims, like a cosmetic product that makes healthcare claims about better skin despite no evidence to back it up.
Under a Trump FDA, the agency could be more lenient in enforcement, Gaba said.
“I anticipate there may be some more leniency about these gray areas about labeling and foods and dietary supplements where some companies have been getting aggressive around claims that they make,” he said.
One advocacy group is dismayed over comments Trump made concerning the FDA’s oversight of food regulation and Trump’s pick of Price as secretary of HHS.
“We don’t know for certain, but we have reason to be very concerned,” said Jim O’Hara, director of health promotion at the Center for Science in the Public Interest. “We have reasons to be concerned for the health and literally lives of Americans who have died because of criminal activity by food companies.”
Price voted against the Food Safety and Modernization Act in 2010, which set in place new regulations to prevent food-borne illnesses.
A fact sheet released by the Trump campaign had initially called for rolling back the “food police” at the FDA, but it was later deleted with no reason, according to the Associated Press.
The president-elect’s transition team did not return requests for comment.
