What Will CDC, FDA, and CMS Look Like After the Election?

What will the health agency landscape look like if former President Donald Trump is elected on Tuesday, and what about if Vice President Kamala Harris is the winner? MedPage Today asked several health experts for their opinions.

CDC

Under a possible Trump administration, “I think the biggest risk is that CDC will be weaker, and if CDC is weaker, that means we are less safe, [and] we are less healthy,” Tom Frieden, MD, president and CEO of Resolve to Save Lives, a global health organization focused on addressing heart disease and epidemics, told MedPage Today. Frieden served as CDC director from 2009 to 2017.

A number of conservatives, from current lawmakers to former officials, have argued that many of the CDC’s programs are duplicative and out of step with the agency’s core mission. They say the agency should focus solely on infectious diseases.

On Oct. 17, Scott Gottlieb, MD, a former FDA commissioner under President Trump from 2017 to 2019, penned an editorial in JAMA Health Forum supporting the idea of rethinking the CDC’s responsibilities.

Gottlieb argued that many of the CDC’s activities duplicate or overlap with those of other agencies — for example, the Substance Abuse and Mental Health Services Administration’s work on addressing opioid use and overdose trends.

“Allowing certain activities to be transferred to other agencies in exchange for a strengthened infectious disease control budget could set the stage for a revitalization of CDC,” Gottlieb wrote, calling this a “political compromise,” which he suggested would “create a stronger, more coordinated framework for public health.”

Other former Trump officials, including Joseph Grogan, JD, nonresident senior scholar for the USC Schaeffer Center in Los Angeles, and an assistant to Trump and director of the Domestic Policy Council during his first term, have also suggested that the agency needs an overhaul.

In an interview during a summit hosted by STAT in mid-October, Grogan said, “CDC is spending a whole bunch of money and distracted in areas where it’s not their core mission. I mean, they should be focused on fighting infectious and communicable diseases. They are far too bogged down in chronic disease.”

Frieden and seven former CDC directors published an editorial in STAT in September, arguing that drastically cutting the agency’s budget would be a “prescription for disaster.” In an interview with MedPage Today, Frieden said the claim that the CDC’s core mission is to focus on infectious diseases is a “harmful” misconception. “I think Gottlieb is saying, ‘Just deal with infectious diseases and don’t bother your little head with all these other problems.’ Well, that means not addressing the leading causes of illness, injury, disability, and death in the U.S.”

“The CDC’s mission is healthier, safer people, and that means dealing with injury. That means dealing with data on road safety … That means dealing with opiates. If Congress allows, that means dealing with how can we improve gun safety,” Frieden added.

Georges Benjamin, MD, executive director of the American Public Health Association, said he believes that the talk of moving chronic disease programs out of the CDC belies an ulterior motive “to cripple the agency. Chronic diseases are the leading causes of death and disability in this country, right? And we know that health promotion and disease prevention can go a long way to reducing the morbidity and mortality” from those diseases, he said in an interview.

“But if you look at how CDC is funded for chronic diseases, it’s totally inadequately funded,” he noted. The Biden administration, for example, has tried for several years to allocate funding to the CDC for a “Vaccines for Adults” program to pay for vaccines for uninsured and low-income adults, but has gotten nowhere.

In general, said Benjamin, “the Trump administration looks at the health system [with the idea that] government should be minimally involved in the system and that the market will take care of it. The Harris administration has a view that healthcare is a market failure and requires more regulation and more engagement in order to control it.”

“I hope that both administrations promote people in those jobs that are well-trained, competent, and experts in their fields,” he added. “That means you want an [HHS] secretary with a health background that’s run big systems. You want a CDC director who is skilled in public health, broader than just infectious diseases. I would prefer to see someone who’s actually worked at a state or local health department and knows how to make trains run.”

One person that the Trump campaign has said will be involved in healthcare policy in some capacity if Trump wins is Robert F. Kennedy Jr., who recently debuted his Make America Healthy Again (MAHA) agenda, calling for a renewed focus on chronic diseases, improving life expectancy, and eliminating ultra-processed foods.

In a video for the MAHA initiative, Kennedy said his “big priority will be to clean up the public health agencies like CDC, NIH, FDA, and U.S. Department of Agriculture.”

“Those agencies have become sock puppets for the industries they’re supposed to regulate,” he added.

Frieden noted that in a Wall Street Journal editorial, Kennedy “didn’t say it explicitly, but the implication was that it’s a bad thing that 30% of people in this country are on treatment for a chronic disease. I think you can say, in an ideal world, we would all be perfectly healthy without medicines, but to suggest that medicine is bad and a symptom of failure is dangerous,” he said.

For example, with hypertension, “the problem isn’t that too many people are treated, it’s that too few people are treated … Only about half of people with high blood pressure in the U.S. have it under control. That’s a stunning indictment … of the lack of primary healthcare in our healthcare system, and the result of it is a lot of heart attacks, a lot of strokes, a lot of kidney failure, a lot of dementia that was preventable. And the treatment is all generic and low cost. So I worry when there’s this idea of ‘medicine bad, natural good,'” Frieden said.

FDA

The FDA under a Harris administration is not likely to undergo many changes, according to Douglas Holtz-Eakin, president of the American Action Forum, a conservative think tank. “I view her as very much a status quo candidate … She will take the path of least resistance.”

Trump, on the other hand, “has not been the biggest advocate for pharmaceutical manufacturers,” Holtz-Eakin, who served as director of the Congressional Budget Office from 2003 to 2005, said in a phone interview. “I’d expect much tougher use of the existing FDA,” including more after-market surveillance of new products and more scrutiny of drug approvals, “and not letting things skate by with emergency use authorizations.”

Although the Biden administration has minimized the role of FDA’s advisory committees, “I think a Trump regime would flip that,” he said, instead adopting a philosophy of “let’s have strong authority of outside committees and have the authority to stop things they think are inappropriate.” Holtz-Eakin also predicted hikes in the user fees that drug companies are required to pay FDA under the Prescription Drug User Fee Act (PDUFA): “I think they would be happy to extract more money.”

Although Project 2025 — a proposed blueprint for a Trump administration written by former Trump associates — has suggested a major overhaul for FDA, Holtz-Eakin seemed skeptical. “Is that real? It’s hard for me to tell,” he said, noting that Trump has “kept at arm’s length” from Project 2025. But he added that it was likely Trump would take action in another area: negotiating lower prescription drug prices.

Although classic Republican philosophy argues for fewer restrictions on businesses, including drug companies, “this administration is not a classic Republican one,” Holtz-Eakin said. “This is a man who [lobbied for an] international [drug] price index and went for all these things that essentially looked a lot like the Biden regime.” And Trump could use CMS’ new drug price negotiation program “for whatever he wanted to get … if I’m pharma, that would make my blood run cold.”

CMS

When it comes to CMS, although there are a few issues where Trump’s and Harris’ approaches would be different, “for some of the most important issues like drug pricing and Medicare Advantage, it’s really difficult to discern how the two campaigns would be different,” said Paul Ginsburg, PhD, former vice chair of the Medicare Payment Advisory Commission (MedPAC) and now a professor of health policy at the University of Southern California in Los Angeles.

One of the areas of difference will likely be the Affordable Care Act (ACA) — specifically with regard to the continuation of enhanced subsidies for low-income enrollees, said Ginsburg, who is also a nonresident senior fellow at the Brookings Institution. Although the Biden administration extended the subsidies, “the Republicans are not in favor of that and won’t be in favor of that,” he said, adding that it’s possible some deals will be made depending on which party wins the presidential and congressional elections.

The other big issue is Medicaid, Ginsburg continued. “Traditionally, Republicans talk about block granting; I wouldn’t be surprised if there would be some attempt to do that,” he said. Block grants refer to the idea of allocating lump-sum payments to states to spend on Medicaid as they see fit, within broad guidelines. “The Democrats would never propose that type of approach and will certainly be against it.”

Matthew Fiedler, PhD, a senior fellow with the Center on Health Policy at the Brookings Institution, said any changes to the ACA and Medicaid would depend heavily on the balance of power in Congress. As for whole-cloth repeal, nothing “branded as ACA repeal” would be introduced, Fiedler said; however, proposals mirroring past repeal efforts that reduce the generosity of ACA marketplace plans or the generosity of the Medicaid program, including per-capita caps or block grants, could be put forward.

On a separate issue, a possible Trump administration would be likely to once again support state work requirement waivers. Such waivers were previously blocked by the courts, but the Supreme Court never issued a final decision on the matter, he noted. Were a Trump administration to try again, one might “see the litigation unfold differently.”

As for insurance regulation, the Trump administration “substantially liberalized rules” related to short-term limited-duration coverage with regard to how long plans can last and the terms under which they can be sold, Fiedler said. The Biden administration, which referred to the plans as “junk insurance plans” tightened requirements, but Fiedler expects the Trump administration to reverse those actions.

Asked about a possible repeal of the Inflation Reduction Act — a law that, for the first time, allows Medicare to negotiate drug prices — Fiedler said while many Republican lawmakers are hostile to price negotiation, the Trump administration’s own record is “confusing.”

During Trump’s first term, he put forward his “most favored nations” model, a proposal that tied U.S. drug prices to those of other advanced industrialized countries. That proposal, had it been implemented, would have substantially lowered drug prices, Fiedler said. But the law was enacted “in a way that it was almost certain to be blocked in court,” he added, in a move that he believes is reflective of disagreement within the administration.

Marsha Simon, PhD, an expert in legislative strategy and an independent drug industry analyst in Washington, D.C., took a different view. She argued that “in terms of taking on the drug manufacturers, [Trump] went much further than any Democratic administration,” pointing to his attempt to implement re-importation of drugs from other countries and his “most favored nations” proposal.

Recently, the Trump administration backed off its support for the previously sought-after drug pricing plan, STAT reported, but Simon said she is still hearing rumors it could make a comeback.

One other area where the Trump administration took the lead is in hospital price transparency and in transparency of reimbursement rates by commercial health plans, Simon said. “And every indication suggests that they’ll lean in on that” again, she added.

Disclosure: Former CDC Director Tom Frieden is a cousin of Joyce Frieden, one of the authors, but she did not interview him for this story. The interview was done by co-author Shannon Firth.