ACR Endorses Woodcock for FDA Commissioner, Begins Relationship Building with New Administration Leaders

As President Biden took office on Jan. 20, a new cadre of policymakers began their tenure in the Department of Health & Human Services (HHS) and its agencies. New leadership at HHS, the Food & Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), the Center for Medicare & Medicaid Innovation and the Centers for Disease Control & Prevention (CDC) provides an opportunity for the ACR to develop new relationships with decision makers within HHS.

The Biden administration has dedicated much of the first two months in office focused on the COVID-19 public health emergency. However, the ACR looks forward to working with the agencies on other priority areas as well, including preserving evaluation and management (E/M) code valuation, vaccine distribution and health equity, telehealth and drug pricing policies. We look forward to building strong relationships with the HHS secretary and his advisors, the FDA commissioner (when nominated), the CMS administrator and the CDC director.

On March 18, Xavier Becerra was narrowly confirmed to serve as the Secretary of HHS. A former member of the House of Representatives and most recent attorney general of California, Secretary Becerra has a history of focusing on drug pricing throughout his career. As Secretary, he will lead HHS in the COVID-19 public health emergency response and face numerous other issues, including expanding telehealth, strengthening the workforce, health disparities and the cost of prescription drugs. Following his confirmation, ACR sent a letter of congratulations to the new secretary and offered to be a resource to the department as they develop policies on these complex issues.

Additionally, with the approval of its Board of Directors, the ACR sent a letter to Secretary Becerra and President Biden strongly supporting Janet Woodcock, MD, to be nominated as the FDA’s permanent commissioner. Dr. Woodcock is currently serving as the acting commissioner and has been with the FDA for 37 years. She previously served as the director of the Center for Drug Evaluation & Research and has led tremendous progress in the drug approval process, biosimilar pathway implementation and risk evaluation and mitigation strategies. Moreover, Dr. Woodcock has been an excellent partner to the ACR in years past. The ACR looks forward to building on this relationship should she be nominated to serve as the FDA’s permanent commissioner.

In the coming months, ACR staff and volunteer leaders will work to cultivate relationships with new policymakers within the CMS and CDC to ensure the preservation of the E/M code valuations, prevent harmful policies related to drug pricing that would limit access to needed treatments, collaborate on policies related to telehealth expansion and serve as a resource on vaccine distribution and ongoing COVID-19 efforts. We look forward to working with the new administration to address these issues to allow rheumatologists and rheumatology professionals to care for their patients.

The ACR’s director of regulatory affairs, Amanda Grimm Wiegrefe, MScHSRA, can be reached at advocacy@rheumatology.org.