Court sides with PhRMA on Orphan drug discounting

The U.S. District Court for the District of Columbia vacated an interpretive rule that would have required manufacturers to provide discounts on Orphan drugs under Medicare's 340B program when the drugs are used for non-Orphan indications. HHS's Health Resources and Services Administration (HRSA) had issued the rule in July 2014 (see BioCentury Extra, July 21, 2014).

The court granted a motion for summary judgment by the Pharmaceutical Research and Manufacturers of America, which had challenged the rule, and denied a motion for summary judgment by HHS. The court concluded the rule was contrary to the plain language of the statute it interprets, section 340B(e) of the Public Health Service Act (PHSA). ...