U.S. Public Health Service Rear Adm. Krista Pedley, a top official at the Health Resources and Services Administration (HRSA) and former longtime head of the 340B drug pricing program, has been selected by the American Society of Health-System Pharmacists (ASHP) to receive the group’s 2022 William A. Zellmer lecture award on Sept. 13.
The lecture and award ceremony is part of ASHP’s annual Policy Week in Washington, D.C., next week. The lecture is “given by a distinguished individual who has demonstrated exceptional leadership in advancing healthcare-related public policy that has improved the safety and effectiveness of medication use through the engagement of pharmacists,” the group said in a Sept. 7 news release. The award is named for William Zellmer, a former ASHP deputy executive vice president for ASHP who worked for the organization in a range of capacities since 1970.
Pedley currently serves as HRSA’s director of the Office of Special Health Initiatives (OSHI), into which the 340B pricing program was moved in early 2021 as part of a major HRSA overhaul initiated during the Trump administration.
The OSHI division also includes HRSA’s vaccine injury compensation, global health, oral health, and behavioral health programs. Pedley was promoted to rear admiral and assistant surgeon general in February 2020.
Prior to her promotion to OSHI director in January 2021, Pedley led for more than a decade HRSA’s Office of Pharmacy Affairs (OPA), where she directly managed the 340B pricing program. Pedley, who is a pharmacist, transferred to HRSA in 2007 after serving in the Office of the Health and Human Services Secretary and at the Food and Drug Administration.
“I am honored to receive this award, following in the footsteps of so many of my former mentors who led the way for the profession of pharmacy and the advancement of the nation’s health, Pedley said in a Sept. 8 statement. “This award highlights the importance of pharmacy leadership and its contributions to the profession through policy development and a focus on medication use—which is a reflection of the many opportunities I have had throughout my career in the U.S. Public Health Service.”
Due to ongoing litigation, Pedley probably will not comment in her speech on hot-button 340B issues such as drug makers’ contract pharmacy restrictions or the status of the 340B administrative dispute resolution process.
During her tenure at OPA, Pedley oversaw a major expansion of 340B brought about by the Affordable Care Act and 2010 program guidance clarifying that covered entities could contract with multiple outside pharmacies. She tried in 2014 to issue a comprehensive 340B program regulation that at a minimum was expected to cover the 340B patient definition, contract pharmacy arrangements, hospital eligibility requirements, and enrollment of hospital offsite facilities.
The so-called mega-reg came off the rails when a federal court ruled that year that HRSA had authority to issue 340B program regulations only for 340B ceiling prices, manufacturer civil monetary penalties, and administrative dispute resolution. A follow-up attempt to issue comprehensive 340B program mega-guidance also failed.
Pedley remains a strong advocate of giving HRSA power to issue binding regulations for all aspects of the 340B program. Congress would need to pass legislation to give the agency broad regulatory authority. HHS Secretary Becerra reiterated this message in a recent letter to members of Congress who have been pushing HHS to step up its enforcement of drug manufacturers that are placing restrictions on the contract pharmacy program.
