Drug manufacturer Lilly says it hopes the new 340B administrative dispute resolution regulation "addresses the serious shortcomings of the current rule.”

Update: Lilly Comments on Forthcoming New 340B Dispute Resolution Rule

Drug manufacturer Lilly said this morning it looks forward to reviewing the Biden administration’s proposed new 340B administrative dispute resolution (ADR) regulation when it becomes available “and hope[s] that it addresses the serious shortcomings of the current rule.”

“As Lilly has been arguing for some time, and a federal court has now explicitly recognized, the 340B program is broken and can no longer be ‘implemented fairly for all concerned,’” a company spokesperson said. “The January 2021 340B Administrative Dispute Resolution (ADR) rule is one aspect of this program that must be fixed. In fact, a federal court agreed with Lilly that the ADR rule was promulgated unlawfully and issued a preliminary injunction against it.”

“Lilly remains committed to finding solutions that ensure patients benefit fully from 340B discounts,” the spokesperson said.

As 340B Report broke the news on Saturday, the administration disclosed late last Friday that it plans to replace the current ADR rule “with an entirely new rule that “better aligns with the president’s priorities on drug pricing [and] better reflects the current state of the 340B program.” The new proposed rule is expected to be published for notice and comment next month.