James A. Byrne U.S. Courthouse, which houses the U.S. Court of Appeals for the Third Circuit and the U.S. District Court for the Eastern District of Pennsylvania, in downtown Philadelphia, Pennsylvania. Photo: Diego M. Radzinschi/ALM
In a precedential opinion, the U.S. Court of Appeals for the Third Circuit sided with drugmakers in holding that the Department of Health and Human Services “overstepped” the bounds of requiring delivery of Section 340B-discounted products to “an unlimited number” of contract pharmacies.
“Statutory silences, like awkward silences, tempt speech,” Judge Stephanos Bibas wrote for the court. “But courts must resist the urge to fill in words that Congress left out. The Department of Health and Human Services claims that drug makers must deliver certain discounted drugs wherever and to whomever a buyer demands. But the relevant law says nothing about such duties. So HHS’s efforts to enforce its interpretation against the drug makers here are unlawful.”
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