PhRMA has asked a federal judge to strike a hospital survey from a friend-of-the court brief filed by 340B healthcare providers. [ms-protect-content id=”2799″] The brief was filed late last month in support of a Department of Health and Human Services [HHS] rule that allows certain hospitals to receive discounted pricing on “orphan” drugs when not used to treat rare diseases.
PhRMA wants the U.S. District Court for the District of Columbia to strike survey findings that are part of an amicus brief from Safety Net Hospitals for Pharmaceutical Access (SNHPA), America’s Essential Hospitals, and the National Rural Health Association — and those portions that rely on the survey. The drug industry association argues that the findings should be dropped because they were not available at the time that HHS made its decision to issue this rule.
“… This information was not part of the record before [HHS] at the time of its decision. Because the Agency did not consider them as part of the Administrative Record, PhRMA respectfully requests that this Court strike the SNHPA Survey Results,” said the request.
The survey was conducted by SNHPA and represents responses from over a hundred 340B hospitals. It shows that on average, the providers anticipate savings over the next year of $20,000 to $2 million on discount pricing of orphan drugs when used for common indications. Further, respondents that are currently purchasing their orphan drugs at 340B prices when used for a common purpose said their outpatient drug spending over the next year would rise by 19 percent if the discount was rescinded, as PhRMA seeks.
On December 31, HHS asked the court to deny PhRMA’s request to strike the survey, saying the judge has the legal discretion to allow use of the information. “At the preliminary injunction stage, the court must consider questions of irreparable harm, the balance of hardships to the parties, and the public interest, matters which may not always be addressed by the administrative record. This exception therefore permits introduction of extra-record evidence to resolve these necessary questions.”
SNHPA General Counsel Maureen Testoni said there is ample case law to allow inclusion of the survey in the proceedings. “PhRMA misses the point. We are letting the court know of the negative impact that PhRMA’s interpretation of the law would have on vulnerable rural and cancer hospitals, which is the whole purpose of an amicus. PhRMA’s legal argument to strike this information from the record falls short and we hope the court agrees.”
SNHPA is expected to file a rebuttal brief with the court today. [/ms-protect-content]