October 16, 2015
On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The opinion can be found here. The Court ruled in favor of PhRMA, a trade association that represents pharmaceutical research and biopharmaceutical companies, and found that the Health Resources and Services Administration’s (“HRSA”) engaged in “final agency action” and its interpretive rule was contrary to the plain language of the 340B statute. The Court granted PhRMA’s motion for summary judgment, and vacated the interpretive rule.

In light of the ruling, 340B covered entities should consider the short-term and long-term implications that this decision will have on their 340B programs. This ruling could significantly increase the cost of drugs for rural and cancer hospitals and could raise concerns regarding enforceability of HRSA’s recently proposed omnibus guidance.

To view the full alert, click here.