As previously reported, on May 17, HRSA sent letters to six pharmaceutical manufacturers stating that their policies restricting 340B priced drugs to contract pharmacies violate the law, that they could be subject to fines, and that they must submit a plan to resume contract pharmacy shipments to HRSA by June 1. However, none of the six manufacturers appear to be taking steps to comply with HRSA’s requirements. Instead, they have requested the courts to block HRSA from taking any enforcement action, including issuing fines, while their lawsuits over the contract pharmacy issue are pending.
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On May 17, HRSA sent letters to six pharmaceutical manufacturers stating that:
- Their refusal to ship 340B-priced drugs to contract pharmacies is a direct violation of the 340B statute.
- They must immediately resume shipping 340B-priced drugs to contract pharmacies.
- They must credit or refund all 340B providers for overcharges that resulted from their policy; it is the manufacturers’ responsibility to contract the 340B providers and purse “mutually agreed upon refund arrangements.”
- If manufacturers continue to refuse to ship 340B-priced drugs to contract pharmacies, this “may” result in HHS imposing Civil Monetary Penalties on them, not to exceed $5,000 for each instance of overcharging.
- Manufacturers must provide HHS with an update on their plans to resume shipping 340B-priced drugs to contract pharmacies by June 1.
It remains to be seen how pharmaceutical manufacturers will respond to the HHS letters. It is very possible that they will pursue further litigation. CHCANYS will continue to work closely with NACHC and our partner PCAs to protect the 340B program