PhRMA did not oppose the extension request, according to court documents filed July 2.
HHS had interpreted the exclusion to mean that certain healthcare providers that participate in the 340B program can purchase orphan drugs for non-orphan conditions at discounted prices made available through 340B, the federal program allowing hospitals that serves a large population of low-income or indigent patients to receive discounts of up to 50% on some outpatient drugs. Orphan drugs are often the most expensive drugs on the market.
Drug companies disagreed, and the lawsuit has been one element of an ongoing public relations and legal battle between safety net hospitals and the pharmaceutical industry over how the 340B program is utilized.
The Health Resources and Services Administration, the HHS agency that administers the 340B program, most recently said that manufacturers should continue to provide the discounts.
The judge's decision, announced in May, more broadly has raised questions about whether HHS now has the authority to issue what industry insiders are calling a mega-reg that would propose new rulemaking related to other parts of the 340B program. That proposed regulation was expected to be released sometime in June.
Representatives from PhRMA and Safety Net Hospitals for Pharmaceutical Access were not immediately available for comment.
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