FDA Chief Counsel Resigns Amid Controversy, Impacting Nominee Confirmation

The pharmaceutical industry faced a significant shakeup this week as Hilary Perkins, the newly appointed Chief Counsel of the Food and Drug Administration (FDA), resigned just two days into her role. The sudden departure has sent ripples through the agency and impacted the ongoing confirmation process for FDA commissioner nominee Martin Makary, M.D.

Perkins' Brief Tenure and Controversial Background

Hilary Perkins, who previously served as assistant director at the Department of Justice's (DOJ) consumer protection branch, was appointed to the FDA role on Tuesday. However, her appointment quickly attracted controversy due to her prior work defending medical abortion access and COVID-19 vaccine mandates under the Biden administration.

In a social media post late Thursday night, Perkins confirmed her resignation, stating, "Unfortunately, my work as a career attorney at the Department of Justice defending the FDA throughout multiple administrations—which I performed consistent with my oath to zealously advocate on behalf of the United States—created an unnecessary distraction from advancing the Administration's priorities."

Impact on FDA Commissioner Nomination

The controversy surrounding Perkins' appointment has had a direct impact on the confirmation process for FDA commissioner nominee Martin Makary, M.D. Senator Josh Hawley, a member of the Senate Health, Education, Labor & Pensions (HELP) committee, had expressed strong opposition to Perkins' appointment, accusing Makary of "attempting to sneak a Biden abortion lawyer" into top FDA leadership.

Hawley's opposition threatened to derail Makary's confirmation, as he was reportedly prepared to vote against the nomination if Perkins remained in her position. However, following Perkins' resignation and Makary's withdrawal of support for her appointment, Hawley changed his stance and voted in favor of advancing Makary's nomination.

Bipartisan Support and Next Steps

Despite the controversy, Makary's nomination has garnered bipartisan support. The HELP committee ultimately advanced his nomination in a 14-9 vote on Thursday, with Democratic Senators Maggie Hassan of New Hampshire and John Hickenlooper of Colorado joining their Republican colleagues in support.

The nomination will now move to a full Senate vote for final confirmation. If confirmed, Makary, a Johns Hopkins surgeon, will join Robert F. Kennedy Jr., the recently appointed Secretary of Health and Human Services, as one of the nation's top health leaders. This leadership change comes amidst a series of personnel shifts initiated by the Elon Musk-led Department of Government Efficiency.