The U.S. Health Resources and Services Administration overnight unveiled a new Contract Pharmacy Services page on the 340B program website that addresses requirements for covered entities but not for pharmaceutical manufacturers.
The webpage links to HRSA’s 2010 contract pharmacy final guidelines that said entities may use multiple contract pharmacies and said the expansion “neither imposes additional burdens upon manufacturers, nor creates any new rights for covered entities under the law.”
The words “pharmaceutical manufacturer” however, are missing from the new webpage. HRSA did not immediately respond to questions this morning about the webpage.
During the past two years, 18 drug manufacturer have imposed conditions on 340B pricing when entities use contract pharmacies. HRSA has told nine their policies are illegal and must end. It has referred seven to the U.S. Health and Human Services Department Office of Inspector General (OIG) for possible imposition of civil monetary penalties.
Eight drug manufacturers are suing HHS and HRSA over HRSA’s 340B program violation notices. They say the 340B statute requires them to sell and ship drugs to entities only.
To date, four federal district judges have ruled on the legality of six of HRSA’s violation letters to manufacturers. While the decisions have been mixed on whether manufacturers may impose conditions on 340B pricing, the judges have struck down and vacated all six letters.
One long-time 340B stakeholder this morning speculated that HRSA might have omitted any mention of manufacturers in the new webpage because of the pending lawsuits or since HRSA thinks the statute is clear about the drug industry’s obligations and that the new site is largely designed to help covered entities better understand the rules of the contract pharmacy program.
Earlier this month, 181 U.S. House members—144 Democrats and 37 Republicans—urged HHS to quickly impose civil monetary penalties against all drug manufacturers that restrict access to 340B pricing when covered entities use contract pharmacies. Sen. Chuck Grassley (R-Iowa), who has been actively engaged on 340B policy matters for over a decade, also has been pressing HHS to act.
In July 2020, HRSA told 340B Report that although its 2010 contract pharmacy guidelines remained in effect, “guidance is not legally enforceable” and “regarding the 340B program’s guidance documents, HRSA’s current authority to enforce certain 340B policies contained in guidance is limited unless there is a clear violation of the 340B statute.”
On Monday, the Biden administration withdrew a Trump administration HHS final rule that the current administration said hindered HHS’s ability “to issue guidance, bring enforcement actions, and take other appropriate actions that advance the department’s mission.”
HRSA Administrator Carole Johnson and HRSA Office of Pharmacy Affairs Director Lt. Cmdr. Emeka Egwim are scheduled to speak Monday at the 340B Coalition summer conference in National Harbor, Md.
This is a developing story. Check back for possible updates.
