Get to Know 340B: HHS Action Against Drug Manufacturers

Contract pharmacies expand access to affordable medications to patients under the 340B drug pricing program. Read on to learn more about actions HHS is taking to protect the program.
HHS Action Against Drug Manufacturers 
Beginning last summer, several major drug manufacturers instituted policies restricting the shipment of 340B priced medications to contract pharmacies. Health centers rely on contract pharmacies to provide expanded access to medications for patients. Manufacturers were limiting the use of contract pharmacies by restricting shipment of 340B-priced mediations to contract pharmacies or making shipments contingent on data requests. 
In response to these actions, HRSA wrote letters to six drug manufacturers (AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi, and United Therapeutics), stating their restrictions on contract pharmacies violated the 340B statute. The letters from HHS directed each manufacturer to submit a plan to resume shipments by June 1, 2021, and stated that continued non-compliance could result in civil monetary penalties. By the June 1, 2021, deadline, none of the six manufacturers had taken actions to reverse their policies. Rather than comply, the manufacturers have been pursuing legal action.  
On September 22, HRSA sent additional letters to the original six drug manufacturers alerting them that due to their non-compliance with the letters sent in May, their case has been referred to the HHS Office of the Inspector General (OIG), which will review the case and determine whether to assess civil monetary penalties on the drug manufacturers.  



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