PhRMA Takes Further Action Against HHS' Orphan Drug Rule
The Pharmaceutical Research and Manufacturers of America (PhRMA) has filed a second lawsuit challenging the 340B Orphan Drug Rule after the Washington D.C. District Court ruled last month that its original suit did not apply to the interpretive rule implemented by the HHS’ Health Resources and Services Administration (HRSA).
The 340B program allows certain hospitals to benefit from up to a 50 percent discount for orphan drugs manufactured by pharmaceutical companies, given that the orphan drugs are being used for a condition other than the disease or disorder for which it was approved. PhRMA challenged this rule asserting that its member companies will bear the burden of costly orphan drug development and production. The group also argued that the HRSA did not have the authority to write and implement the rule. The U.S. District Court for the District of Columbia vacated the Orphan Drug rule in favor of the group.
However, the HRSA responded by implementing an interpretive rule of the 340B policy instead of as an official regulation. When PhRMA appealed, the court ruled that its original injunction did not apply to the interpretive rule.
The Wall Street Journal reports that the PhRMA stands its ground that the HRSA remains on the wrong track through its interpretation of the rule. PhRMA also reacted to the latter’s threat of ordering pharma companies to refund discounts and of enforcing actions for failure to comply.
Ted Slafsky, who heads The Safety Net Hospitals for Pharmaceutical Access, voiced the group’s support for the 340B program. “Once again, big pharma is trying to increase its prices at the expense of rural and cancer hospitals and their patients. These providers depend on 340B savings to serve needy patients and, in many cases, to keep their doors open.”
However, a recent study published in Health Affairs challenges this view and concludes that hospitals using the 340B program are guilty of boosting profits instead of helping poor and uninsured patients.