HRSA to Eli Lilly About 340B Changes: at a Minimum, Insensitive and Potentially Illegal

HRSA’s Office of Pharmacy Affairs posted on its website a letter to Eli Lilly dated Sept. 21. While this letter does not state definitively that Lilly’s refusal to allow 340B-priced drugs to contract pharmacies is illegal, it states that HRSA has not yet made a final decision regarding its legality. Referring to Eli Lilly’s “unilateral policy” to “scrap 340B pricing to contract pharmacies,” the letter states that “although the Health Resources and Services Administration (“HRSA”) has significant initial concerns with Lilly’s new policy, it continues to review that policy and has yet to make a final determination as to any potential action…. Lilly’s decision to interpret HRSA’s responses as tantamount to definitive agency agreement with Lilly’s position is incorrect.” The letter lists four concerns about Lilly’s actions that are not directly related to the 340B statute. The letter also notes that “the timing of your pricing changes is, at the very least, insensitive to the recent state of the economy.” HRSA’s letter concludes by stating that a lawsuit by HRSA against Eli Lilly is “a potential consequence in the event that Lilly knowingly violates a material condition of the program that results in over-charges to grantees and contractors.” NACHC and PACHC will continue to monitor this situation closely.