340B provider and drug industry stakeholders joined yesterday in congratulating U.S. Public Health Service Lt. Cmdr. Emeka Egwim on his selection as Director of the U.S. Office of Pharmacy Affairs, the federal agency that runs the 340B drug pricing program.
The U.S. Health Resources and Services Administration (HRSA) Office of Special Health Initiatives (OSHI) announced Egwim’s selection to HRSA staff yesterday, his first day on the job.
Egwim makes history as the first Black leader of OPA in the 340B program’s history. Egwim most recently was a senior policy analyst in HRSA’s HIV/AIDS Bureau. After earning his PharmD from Howard University in 2011, he worked at OPA both on the 340B program and the Patient Safety and Clinical Pharmacy Services Collaborative.
Egwim next served as a pharmacist in the Centers for Medicare & Medicaid Services (CMS) Medicaid Drug Rebate Program (MDRP). While there, he worked on issues related to 340B and the Medicaid federal upper limit (FUL) on the federal contribution to state Medicaid drug reimbursement, according to contact information that CMS included in its 2016 Medicaid covered outpatient drug final rule.
Several veteran 340B stakeholders said privately yesterday they were not personally acquainted with Egwim. They said they were eager to get to know him and to learn more about his background and his priorities for OPA.
Egwim is taking command at OPA amid HRSA’s battle with 14 major brand drug manufacturers over the companies’ decisions to impose conditions on 340B pricing when covered entities use contract pharmacies. HRSA told six of the companies their actions were illegal and had to stop and threatened them with possible civil monetary penalties.
While the federal court decisions on the six cases varied with some more favorable to providers and others to the drug industry, all the judges involved have struck down and vacated HRSA’s violation letters. A seventh HRSA violation letter to a manufacturer also is being challenged in court. That case has been stayed pending federal appellate court decisions in the first six cases.
HRSA’s 340B administrative dispute resolution (ADR) regulations also are being challenged in federal courts. HRSA wants to replace the year-old ADR regulations with new ones that it says “better aligns with the President’s priorities on drug pricing, better reflects the current state of the 340B program, and seeks to correct procedural deficiencies in the 340B ADR process.” The new regulations are still awaiting White House clearance to be published for notice and comment.
Groups Offer Congratulations
Pharmaceutical Research and Manufacturers of America (PhRMA) congratulated Egwim “for his new role as Director of the Office of Pharmacy Affairs and welcomes the opportunity to work him to get the 340B program back on track for vulnerable patients.”
AIDS Healthcare Foundation (AHF) National Director of Advocacy John Hassell said, “The drug industry is assaulting the 340B program and we’re hopeful that Dr. Egwin will defend it based on his experience with the Ryan White HIV/AIDS Program. We’re encouraged that throughout his career he has focused on ways to keep people living with HIV in care. We wish him much success.”
Ryan White Clinics for 340B Access (RWC-340B) said Egwim’s selection “sends a strong and welcome signal that the administration recognizes the importance of the 340B program, especially for vulnerable populations.”
“Egwim is notable on many fronts—as a pharmacist and clinical expert in HIV/AIDS medicine with a targeted focus on improving diversity and equity,” RWC-340B President Shannon Stephenson said. “RWC-340B is eager to work with Dr. Egwim as we too have long fought to ensure that the 340B program protects the most vulnerable patients.”
America’s Essential Hospitals noted that Egwim earned his PharmD at Howard University College of Pharmacy, which is affiliated with its member Howard University Hospital in Washington, D.C.
“His work on the 340B Drug Pricing Program, as well as with the Patient Safety and Clinical Pharmacy Services Collaborative, to improve the quality of care and address costs for patients with complex conditions makes him ideally suited to his new role,” said Beth Feldpush, America’s Essential Hospitals Senior Vice President of Policy and Advocacy. “We look forward to working with Egwim to protect the access to affordable drugs the 340B program creates for low-income patients, including through pharmacies that contract with hospitals. These pharmacies extend the reach of the program and help marginalized patients overcome transportation and other barriers to care. We offer our support to OPA to resist the pharmaceutical industry’s attempts to undermine these important relationships.”
340B Health President and CEO Maureen Testoni said the hospital group “look[s] forward to working with [Egwim] to further the vital patient care mission that is at the heart of 340B. His impressive level of experience working on 340B, Medicaid drug rebates, and HIV/AIDS care makes him an excellent choice to lead this office at this critical time.”