Sen. Pat Toomey
(R-Pa.) following the vote justified his pivotal yes by arguing other potential nominees for the role would likely be less palatable.
“I think when you when you look at these decisions in their context, I don’t think that it, in my view, makes sense to blame him for these outcomes,” Toomey told POLITICO, in response to questions about other senators’ opposition to Califf over the FDA’s opioid and abortion policies. “I think he would be far better than many other folks that the administration might be considering.”
Here are six issues Califf will face as commissioner:
Emergency use authorization: The Covid-19 pandemic will continue to dominate FDA’s attention for the foreseeable future. But the disease’s trajectory poses broader issues: How does the agency transition myriad tests and treatments from emergency use authorization once the public health emergency expires, and how might it reform the process?
It’s unclear how federal health officials might wind down the public health emergency determination. Even as cases drop, 18 Covid-related drugs and vaccines are only available under EUAs for some portion of the population, not to mention myriad medical devices like antigen tests.
While a separate HHS declaration that circumstances exist to justify the authorization of drugs and biological products to treat Covid underpins FDA’s power to issue EUAs, pressure is ramping up on Biden to wind down the broader federal public health emergency.
Califf must confront what to do with that web of contingent authorizations as pressure builds to move on from the public health emergency.
User fees: Califf will retake the top political job at an agency amid ongoing negotiations over consequential user fee programs subject to reauthorization every five years.
FDA and the medical device industry are still working behind the scenes to reach an agreement on the next iteration of the Medical Device User Fee Amendments. Lawmakers from both parties are pressuring the two sides to quickly conclude negotiations so Congress has time to prepare a legislative reauthorization package.
Other FDA priorities — like expanding when firms are required to report shortages of medical devices — may get attached to the user fee package.
Several other hot-button issues could come up throughout congressional debate as lawmakers try to attach their priorities to these must-pass bills. Efforts to pass new pandemic preparedness legislation as well as a second iteration of the 21st Century Cures Act may also be attached to the user fee package.
Accelerated approval pathways: With Califf at the helm, he’ll likely receive the bulk of lawmaker and patient advocacy group pressure around the accelerated approval pathway.
FDA used the accelerated approval pathway for Aduhelm, an Alzheimer’s therapy from Biogen. This pathway considers a surrogate endpoint as a metric of success rather than overall patient outcomes. It also requires drug makers to conduct another post-market clinical trial, though the agency has historically been lax with rescinding approvals for therapies that never get additional studies.
Critics have argued that Aduhelm shouldn’t have been approved based on the mixed results of two late-stage studies. The debate steamed up when news reports from STAT illustrated off-book meetings with FDA regulators and Biogen employees during the approval process. And most recently, the Centers for Medicare and Medicaid Services proposed severely limiting coverage of Aduhelm for patients enrolled in another clinical trial.
At a recent user-fee agreement hearing, lawmakers pressed agency officials on the circumstances of Aduhelm’s approval. After the drug’s approval, the HHS office of the inspector general launched a probe into the accelerated approval pathway in general.
Tobacco regulation: The tobacco industry and public health experts are eagerly awaiting to see how FDA’s Center for Tobacco Products will handle e-cigarettes and menthol cigarettes — two of the most contentious issues in tobacco regulation whose fates, as of now, remain undecided.
The agency has blown past its Sept. 9, 2021 deadline to declare whether some e-cigarettes should remain on the market. Although it’s taken action on 99 percent of nearly 6.7 million vape products, it has yet to make decisions on major market players, including Juul and NJOY. Groups focused on preventing youth vaping argue that the agency has yet to take meaningful actions on the products that ignited youth vaping trends. The vaping industry, meanwhile, argues that the agency’s actions so far have only limited the number of products for adult vapers — who they say use these products to quit smoking — and contributed to the first increase in cigarette smoking in two decades.
The agency is also slated to take action to ban menthol cigarettes by April. Menthol cigarettes make up roughly a third of all cigarettes — and disproportionately harm African American and Latino populations. Several public health groups have been calling for their market removal for over a decade.
Califf will also have to find a new chief tobacco regulator come April, too. Mitch Zeller, who has been serving in that position for nearly nine years, is slated to step down.
Opioids: Lawmakers from states hit hardest by the opioid epidemic will be keeping a close eye on what Califf does — or doesn’t do — differently with respect to opioid approvals and labeling. Several Democrats focused on the issue during his confirmation hearing, with New Hampshire’s Sen. Maggie Hassan
ultimately deciding to oppose his nomination at committee after deciding it did “not appear that things would be different under his leadership.”
Hassan and other Democrats have said they want to see FDA address labeling guidance for opioid prescriptions, as well as an accounting of past decisions to approve such drugs despite a saturated market or independent advisers’ opposition. Meanwhile, the CDC is seeking comment on an update to its opioid prescribing guidelines, proposing they be softened to better accommodate individual patient needs. That action could prompt even more attention from Congress on federal health officials’ posture on opioids, which killed a record number of Americans in 2021, after nearly 500,000 overdose deaths related to prescription and illicit opioids were recorded from 1999 to 2019.
Even though Califf only spent one year leading FDA at the end of President Barack Obama’s second term, lawmakers like Sen. Joe Manchin
say he bears some responsibility for the agency’s role in the crisis.
“He has shown a complete lack of interest in actually making the difficult decisions we need the leader of the FDA to make,” the West Virginia Democrat said Monday while urging a “no” vote against the nominee.
Abortion pills: Many Republicans who voted to confirm Califf under the Obama administration — and others newly elected since then — decided to oppose him over the FDA’s December decision to loosen restrictions on abortion pills and allow them to be prescribed via telemedicine and delivered by mail or picked up at pharmacies. For decades, the FDA required the drug to be dispensed in person by a physician even though patients could take them home to ingest them. The Biden administration — prior to Califf’s confirmation and even nomination — first decided last spring to suspend the in-person requirements for the duration of the Covid-19 pandemic after the American College of Obstetricians and Gynecologists brought a lawsuit arguing the rule did more harm than good.
Now, Califf will be at the top of the agency as it finalizes the new rules for how the pills are dispensed after the pandemic ends. He could also get drawn into legal battles between the swath of conservative states that are imposing their own restrictions on the drugs, which some legal groups view as an unlawful preemption of federal policy.