Two federal health officials with long track records managing key aspects of the 340B program are playing pivotal roles in a major overhaul of the U.S. Centers for Disease Control and Prevention.
CDC Director Rochelle Walensky last month named Mary Wakefield, former head of the Health Resources and Services Administration (HRSA), to lead a broad restructuring of the CDC, in the wake of a backlash against the agency for its bungled response to the COVID-19 pandemic.
Wakefield, who headed HRSA from 2009 to 2015 during the Obama administration, has served since May 2021 as counselor to U.S. Health and Human Services Secretary Xavier Becerra.
While serving as HRSA administrator, Wakefield managed the 340B program’s expansion under the Affordable Care Act, both in terms of expanded eligibility and program integrity enhancements.
Also during Wakefield’s tenure, HRSA published 340B program final guidance in 2010 clarifying that covered entities could contract with an unlimited number of pharmacies to dispense 340B-purchased drugs, the policy that gave rise to the current dispute between 340B providers and drug makers over 340B entities’ use of contract pharmacies.
Wakefield also oversaw the initiation of compliance audits of covered entities and drug manufacturers.
Wakefield left HRSA in March 2015 to serve as acting HHS deputy secretary—the agency’s second highest post—during the final years of the Obama Administration.
In November 2020, Wakefield was selected to serve on the Biden administration transition team for HHS. Wakefield played a key role in advising U.S. Health and Human Services Secretary Xavier Becerra on selecting staff to oversee HRSA. Carole Johnson, a former Obama administration official who had been serving as President Biden’s COVID-19 testing Czar, took over as HRSA Administrator in January 2022. Kaiser Health News and CNN jointly published a long-profile of Wakefield yesterday.
Deep 340B and Leadership Experience for Macrae
Last April, Walensky tapped HRSA Associate Administrator James Macrae to lead an external review of CDC, laying the groundwork for the agency revamp.
Macrae heads up HRSA’s Bureau of Primary Health Care (BPHC), which runs the agency’s community health center program, first joining the BPHC division in 2006.
Macrae has a strong understanding of the 340B program due to his role leading HRSA on an acting capacity for a two-year period between 2015-2017. In addition, he regularly has focused on 340B matters at BPHC. Community health centers are some of the largest purchasers in terms of numbers of 340B-priced drugs.
In that capacity, Macrae manages a $5 billion budget that supports nearly 1,400 community health centers, according to HRSA’s website.
Macrae took over as HRSA’s acting administrator when Wakefield left for the HHS post, serving from April 2015 to April 2017. Macrae, a civil servant, has served both Democratic and Republican administrations. Walensky announced the CDC restructuring plan in mid-August as the agency reeled from criticism of its mishandling of the pandemic. Goals of the CDC reorganization include shoring up pandemic response, and delivering scientific information and guidance to the public in a more timely and understandable manner.