In a setback to Johnson & Johnson, a federal decide dominated {that a} U.S. authorities company didn’t violate the regulation when it required the corporate to hunt approval earlier than providing rebates to hospitals and clinics that take part in a drug low cost program.
The choice marks the second time in as many months {that a} federal court docket sided with the U.S. Well being Assets and Providers Administration, which final 12 months pushed again towards plans by a number of drug makers to change their fee fashions for the 340B Drug Low cost Program. Final month, a special decide reached the identical choice in lawsuits introduced by Eli Lilly, Bristol Myers Squibb, and Novartis.
“Primarily based on the plain and unambiguous language of the 340B statute, and supported by its goal and historical past, HRSA has the authority to supply for reductions, rebates, or each. This conclusion defeats J&J’s declare that HRSA lacked the authority to require prior approval of J&J’s rebate mannequin,” U.S. District Courtroom Decide Rudolph Contreras wrote in his choice.
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