Health Care

How FDA’s new head could shape agency policy

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Dr. Robert Califf was nominated by President Joe Biden last week to lead the Food and Drug Administration. If confirmed, Califf will lead an agency still fighting against the COVID-19 pandemic while working to innovate.

Califf previously served as FDA commissioner for nearly a year at the end of the Obama administration. He knows how the agency works and can hit the ground running, stakeholders say. Califf’s leadership style revolves around setting key priorities and following through on them, according to Howard Sklamberg, a partner at Arnold & Porter who worked as a deputy commissioner at the FDA during Califf’s first tenure.

Here are five policy themes to watch for as the FDA moves into a new phase of leadership.

1. Continued attention to COVID-19

Califf will likely prioritize dealing with the COVID-19 public health emergency, the FDA’s constant priority for nearly two years. The agency needs to keep paying attention to vaccine, testing and drug development related to COVID-19, said Heather Pierce, senior director of science policy and regulatory counsel at the Association of Academic Medical Colleges.

New COVID-19 therapies are still being developed, like Pfizer’s pill put up for FDA authorization earlier this week. Califf will likely be involved in those decisions, said Susan Lee, a partner in Goodwin Proctor’s life sciences practice.

Some stakeholders want the FDA to improve the way it communicates pandemic-related policies to providers and patients. Mark Howell, senior associate director for hospital standards and drug policy at the American Hospital Association, said the group has talked with the FDA about streamlining communication around emergency use authorizations and thinks the agency is trying to move towards that.

2. Transitioning out of EUAs as the pandemic winds down

The FDA has used EUAs to bring several devices and drugs to market during the pandemic, which have been immensely helpful to hospitals, Howell said.

But these approvals expire with the public health emergency. The FDA needs to create a transition period so hospitals aren’t suddenly left with unauthorized products when those EUAs lapse, Howell said.

The agency has also exercised enforcement discretion over premarket approval requirements for different products, and it will have to figure out what and how to phase out some of these temporary policies.

3. Additional focus on—and innovation in—clinical trials

Califf, considered an expert on clinical trial research, is passionate about improving clinical trials and evidence development, Sklamberg said. Califf will likely make the trial process more open to real-world evidence.

The pandemic forced the FDA to allow flexibility and innovative clinical trial design, especially around remote monitoring, Lee said. She expects Califf to continue this push.

Clinical trial innovation could also benefit patients and practitioners by getting therapies on the market sooner.

4. More FDA policies to reign in drug costs

The FDA isn’t responsible for drug price regulation. But Califf has spoken out against unsustainable drug costs, indicating he could direct the agency to be more proactive about reeling in prices.

Lee said enthusiasm around innovative clinical trial designs could lead to lower drug costs down the line, since high costs of drug development contribute to high prices for consumers.

The FDA can also work to enhance competition in the pharmaceutical market as a way to control costs. Sklamberg expects Califf to make sure first and second-generation generic drugs on the market have the right resources. Califf will likely also continue former FDA Commissioner Scott Gottlieb’s push to refer anti-competitive behavior in the industry to the Federal Trade Commission, he said.

AHA hopes to see the FDA continue its work around biosimilars—drugs that are nearly identical to an original pharmaceutical—and interchangeable products under Califf, Howell said.

“We’re all about if you can get more generics to market, especially when we’re looking at high-cost biologics,” he said.

5. Pressure to fight opioid and substance use disorder epidemic

Opioid and substance use disorder continues to devastate America, with overdoses rising during the coronavirus pandemic. The Centers for Disease Control and Prevention announced this week that for the first time, drug overdoses exceeded 100,000 over a 12-month period ending in April 2021.

Califf dealt with the same crisis as FDA commissioner in 2016 and 2017 and as deputy commissioner for medical products and tobacco before that. The agency began requiring its strongest warning label on opioid packaging under Califf.

But some lawmakers and advocates think Califf’s ties to the pharmaceutical industry make him a poor choice for commissioner. Califf’s financial disclosures have reportedly shown consulting fees or money to support his Duke University salary from pharmaceutical companies, including some that manufacture opioids. Four senators opposed Califf’s nomination in 2016, and Sen. Joe Manchin (D-W.V.) has already said he won’t vote to confirm Califf this time around either.

These factors could conspire to create additional pressure on and energy from the agency to tackle the epidemic.

AAMC hopes the FDA can parlay lessons learned from the pandemic into tackling the opioid crisis, Pierce said.

“We will be looking to the FDA to be partners on addressing the opioid epidemic, and continuing to—really continuing the themes that we hear about through COVID, of public trust, of community engagement, critical issues related to health equity and how the data that go to the FDA can impact what comes out,” she said.

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