Who Will Head FDA?

Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency. While there has been wide expectation that Sharpless would gain the nomination, nothing is simple in Washington these days. Another cancer specialist, Stephen Hahn, chief medical officer at the MD Anderson Cancer Center in Houston, has emerged as a likely contender. Gaining Congressional confirmation at a very busy time on Capitol Hill could be tricky, though, and everyone is waiting for word from the White House on how President Donald Trump wants to go.

The issue has moved to center stage because Federal law sets a 201-day limit on acting officials in positions requiring Senate confirmation. That means Sharpless’ temporary term ends Nov. 1, 2019, and he’s likely to depart before then. It would be surprising if he stays during the confirmation process of another candidate, and if he is nominated, he would step down as acting, while another agency official fills the job temporarily, as has occurred in the past.

Sharpless has broad support for continuing to lead the agency from former FDA commissioners and numerous disease and patient groups. But Hahn, also a prominent cancer researcher with leadership experience, is a long-time Republican donor, but one without damaging ties to the pharmaceutical industry. Yet the recent scrutiny of his potential candidacy has brought to light some past controversies related to radiation oncology treatment safety, federal rule violations, and employee dismissals.

Hahn’s ties to the White House, though, may be key, as the administration has become more closely involved in FDA issues, namely efforts to combat teen vaping following the emergence of a lethal condition apparently linking to e-cigarette use. And the FDA’s role in allowing the widespread marketing and distribution of opioids remains in the spotlight as the legal battles expose details on manufacturer and distributor involvement in the opioid epidemic. Anticipated resolution of some court cases will continue to raise questions about why and how FDA approved these drugs for market and what changes can prevent opioid abuse and misuse while ensuring access to treatment for patients with serious pain.

The clock is ticking, as Congressional leaders face pressure to address a host of critical issues, including numerous proposals related to healthcare and treatment access. First up is the deadline for funding federal agencies-including FDA-for the fiscal year that begins Oct. 1, 2019. The likely scenario is that multiple drug marketing and regulatory proposals, including provisions on drug pricing and regulation, may be added to year-end must-pass legislation to keep the government going. The tight legislative calendar leaves little time for politicians to wrangle over the appointment of a new FDA commissioner; if that becomes contentious, FDA may have an acting commissioner for months to come.