President-Elect Trump Wants to Speed Up FDA ApprovalsAngie Godinez
As reported today in the New York Times, a single sentence in President-elect Donald Trump’s health-care platform sends a strong hint to the drug and medical device industry that they may have an easier time getting their products on the market under his administration.
“Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products,” his health plan states.
On the face of it, the bullet point may seem almost bland, but efforts to integrate patients’ preferences and encourage innovation often result in proposals aimed at speeding up the process for getting new medicines on the market by easing regulations. Critics argue that such efforts can erode standards that are in place to protect patients from drugs that don’t work and might even be harmful.
“The language … is industry code for deregulation and reducing of safety standards,” said Robert Weissman, president of Public Citizen, a consumer watchdog. “Of course, the general deregulatory rhetoric from candidate Trump is a worry for us, but as applied to FDA, it would be very troubling.”
No one is sure about the precise direction of policy under the Trump administration. But the idea of faster approval of medicines and devices has been popular, meaning this may be one of Trump’s health-plan goals to gain support from both sides of the aisle. The drug industry, which had been preparing to defend its business model and pricing under a possible Hillary Clinton presidency, may now see an opportunity instead to streamline the drug-approval process, which companies have complained can be onerous, bureaucratic and a barrier to competition.
Stephen Ubl, president and chief executive of PhRMA, the trade group for the drug industry, emphasized in a statement the importance of solutions that “enhance the private market.”
“We are in a new era of medicine with treatments and cures that are completely transforming the fight against debilitating diseases,” Ubl said. “To ensure this innovation continues, we need to modernize the U.S. Food and Drug Administration to keep pace with scientific advances, remove regulatory barriers that make it harder to move to a value-driven health care system and focus on making better use of the medicines we have today.”
FDA spokeswoman Jennifer Rodriguez said in an email that the agency “stands ready to work with the incoming administration to protect public health by assuring the safety and efficacy of investigational medical products.”
Mark McClellan, director of the Duke-Margolis Center for Health Policy, said that at a time when there is deep division on many health-care issues, streamlining the process at the FDA may be a rare bit of common ground.
But it may be unwise to read too much into the sentence, given Trump’s unpredictability — and the lack of certainty about who will define his health policy.
“I think the honest answer is nobody knows” what to expect, said Diana Zuckerman, president of the National Center for Health Research. “Some members of Congress owe pharma a favor; we don’t know the Trump campaign is in that position, and they might not be — and that might give them a certain amount of flexibility. The Trump campaign is nothing if not iconoclastic.”
And Weissman thinks that the upturn in biotech and pharmaceutical company stocks after the election may have been overly optimistic. Trump has talked about drug prices as a problem and even said he supported Medicare being allowed to negotiate drug prices — a position the industry opposes. Even if pricing is off the table, the Affordable Care Act extended insurance to millions of Americans who could then get easier access to prescription drugs — and it’s unclear exactly what would replace it. The pocketbook problem of paying for prescriptions won’t go away for people across the country, Weissman points out — which could keep the heat on politicians to do something about prices.