Federal judge denies HHS request to toss 340B suit

A federal judge on Wednesday refused HHS’ request to dismiss AstraZeneca’s challenge to a December advisory opinion from Health and Human Resources Administration blocking drugmakers from charging a covered entity more than the ceiling price for 340B drugs.

U.S. District Judge Leonard Stark in Delaware didn’t rule on the wisdom of the policy but said that the government’s position on drugmakers’ obligations under the 340B program had shifted over time. He said Congress didn’t clearly address the issue of contract pharmacies when it created the drug discount program more than two decades ago.

“Congress may very well want pharmaceutical manufacturers to deliver 340B drugs to an unlimited number of contract pharmacies as a condition for manufacturers’ participation in the Medicare Part B and Medicaid programs. But that kind of policymaking is for Congress, not this Court,” the judge wrote.