Last week, President Joe Biden appointed Dr. Robert Kaliff to head the FDA. If confirmed, Kaliff will lead an agency that is still battling the COVID-19 pandemic while working on innovation at the same time.
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 get down to business right away, stakeholders say. According to Howard Sklumberg, an Arnold & Porter partner who served as Deputy Commissioner at the FDA during Kaliff’s first tenure, Kaliff’s leadership style revolves around identifying key priorities and implementing them.
Here are five policy areas to watch out for as the FDA moves into a new phase of leadership.
1. Continuous attention to COVID-19
Kaliff is likely to prioritize the COVID-19 public health emergency, an ongoing FDA priority for nearly two years. The agency needs to continue to focus on vaccines, testing and drug development related to COVID-19, said Heather Pearce, senior director of science policy and regulatory advisor to the Association of Academic Medical Colleges.
New treatments for COVID-19 are still being developed, such as the Pfizer pills that were up for FDA clearance earlier this week. According to Susan Lee, partner in the life sciences practice at Goodwin Proctor, Califf is likely to be involved in these decisions.
Some stakeholders want the FDA to improve the way healthcare providers and patients are informed about pandemic-related policies. Mark Howell, senior associate director of hospital standards and drug policy for the American Hospital Association, said the group has spoken with the FDA about streamlining communication regarding emergency use approvals and thinks the agency is trying to move in that direction.
2. Exit from the CAP as the pandemic subsides.
Howell said the FDA used the EUA to market several devices and drugs during the pandemic that have been a huge help to hospitals.
But those permits expire with a public health emergency. Howell said the FDA needs to create a transition period so that unapproved foods are not suddenly left in hospitals when these EUAs expire.
The agency has also, at its discretion, applied law enforcement with respect to the prior approval requirements for various products, and will need to figure out what and how to phase out some of these temporary policies.
3. Additional focus and innovation in clinical trials.
Considered a clinical research expert, Kaliff is passionate about advancing clinical research and developing evidence, Sklumberg said. Califf is likely to make the lawsuit more open to real evidence.
The pandemic has forced the FDA to provide flexibility and innovative clinical trial design, especially with regard to remote monitoring, Lee said. She expects Califf to continue this onslaught.
Innovation in clinical trials can also benefit patients and healthcare practitioners, as treatments can reach the market faster.
4. More FDA policy to lower the cost of drugs.
The FDA is not responsible for regulating drug prices. But Califf has expressed against prohibitively high drug prices, indicating that he could instruct the agency to be more proactive in lowering prices.
Li said enthusiasm for innovative clinical trial designs could drive drug costs down in the future, as high drug development costs drive up prices for consumers.
The FDA can also work to increase competition in the pharmaceutical market to keep costs in check. Sklamberg expects Kaliff to ensure that the necessary resources are available on the market for generic first and second generation drugs. Kaliff is also likely to continue with former FDA Commissioner Scott Gottlieb’s efforts to pitch anti-competitive behavior in the industry to the FTC, he said.
Howell said the AHA hopes the FDA will continue its work on biosimilars – drugs that are nearly identical to the original pharmaceuticals – and interchangeable products.
“We’re all about whether you can bring more generics to market, especially when we’re looking at high-cost biologics,” he said.
5. A call to fight the epidemic of opioids and substance use disorders.
Opioid and substance use disorder continues to ravage America, with overdoses on the rise during the coronavirus pandemic. The Centers for Disease Control and Prevention announced this week that drug overdoses topped 100,000 for the first time in the 12-month period ending in April 2021.
Kaliff has dealt with the same crisis as the FDA Commissioner in 2016 and 2017, and before that was the Deputy Commissioner for Medicines and Tobacco. The agency began demanding the strictest warning labels on opioids from Kaliff.
But some lawmakers and rights activists believe Kaliff’s ties to the pharmaceutical industry make him a poor choice for the commissioner. Califf’s financial disclosures reportedly include consulting fees or money to support his Duke University salary from pharmaceutical companies, including those that make opioids. Four Senators opposed Califf’s nomination in 2016, and Senator Joe Manchin (DW.V.) has already said and this time he will not vote to approve Califf.
These factors can conspire to create additional pressure and energy from the agency to fight the epidemic.
The AAMC hopes the FDA can use the lessons learned from the pandemic to address the opioid crisis, Pierce said.
“We will hopefully have the FDA as a partner in the fight against the opioid epidemic and continue – indeed continue the topics we hear about in relation to COVID, public trust, public engagement, critical health equity issues and how this appeal to the FDA might affect what happens, ”she said.