Posted: 27 Jan 2019 07:55 PM PST
In one of the multiple lawsuits that Pharmaceutical Manufacturing Research Services (PMRS) has filed against the FDA related to the approval of abuse-deterrent opioids in the last few years, the Eastern District of Pennsylvania summarily rejected PMRS’s bid to keep abuse-deterrent opioid, RoxyBond, off the market. The Court determined that PMRS did not have Article III standing to challenge FDA’s approval of RoxyBond.
For those unfamiliar with the backstory, PMRS is a contact manufacturer for drug products that has petitioned FDA repeatedly to stop the approval of pending and future opioids indicated for chronic use. These requests have specifically named opioid products approved with abuse-deterrent properties, asking that FDA stay approval of specific products, like RoxyBond, the first immediate release opioid approved for chronic use with abuse-deterrent properties. PMRS has submitted six petitions for stay and citizen petitions to FDA since February 2016 – all asking FDA to either stay or revoke approval of opioids labeled for chronic use. FDA has denied all of these petitions (Strike One) other than the one filed in March 2017 and one filed in November of 2018, which remain pending. PMRS also submitted an NDA for its own abuse-deterrent, immediate release opioid for acute rather than chronic use. FDA issued a Complete Response Letter for the product in November 2017 and denied PMRS’s NDA and Request for A Hearing on October 30, 2018 (which ultimately led to another PMRS lawsuit against FDA) (potentially Strike 3).
In August 2017, PMRS sued FDA arguing that the Agency’s denial of its petitions was arbitrary, capricious, and an abuse of discretion in contravention of the Administrative Procedures Act and asked the Curt to stay the effective date of RoxyBond. On Tuesday, the Court dismissed the case for lack of jurisdiction because PMRS lacks Article III standing. The Court made clear that an agency’s mere denial of a petition does not constitute injury in fact for purposes of Article III standing. PMRS additionally argued that FDA could compare a PMRS application to RoxyBond during the approval process and therefore the approval of RoxyBond would alter the approval process for abuse-deterrent opioids, but the Court rejected that argument as too speculative to establish injury in fact. PMRS also could not rely on the “competitor standing” doctrine either because its NDA did not have tentative approval nor was PMRS a current competitor with RoxyBond.
Notably, this decision sets forth the premise that even if a plaintiff is the recipient of a final agency action, it may not be enough to confer Article III standing. Even having a pending NDA may not be enough to seek judicial review. While we’ll have to wait to see how this is applied beyond the narrow circumstances of this case, it could have ramifications for trade associations or public interest groups that routinely use the Citizen Petition process to try to convince FDA of their policy positions.
For those unfamiliar with the backstory, PMRS is a contact manufacturer for drug products that has petitioned FDA repeatedly to stop the approval of pending and future opioids indicated for chronic use. These requests have specifically named opioid products approved with abuse-deterrent properties, asking that FDA stay approval of specific products, like RoxyBond, the first immediate release opioid approved for chronic use with abuse-deterrent properties. PMRS has submitted six petitions for stay and citizen petitions to FDA since February 2016 – all asking FDA to either stay or revoke approval of opioids labeled for chronic use. FDA has denied all of these petitions (Strike One) other than the one filed in March 2017 and one filed in November of 2018, which remain pending. PMRS also submitted an NDA for its own abuse-deterrent, immediate release opioid for acute rather than chronic use. FDA issued a Complete Response Letter for the product in November 2017 and denied PMRS’s NDA and Request for A Hearing on October 30, 2018 (which ultimately led to another PMRS lawsuit against FDA) (potentially Strike 3).
In August 2017, PMRS sued FDA arguing that the Agency’s denial of its petitions was arbitrary, capricious, and an abuse of discretion in contravention of the Administrative Procedures Act and asked the Curt to stay the effective date of RoxyBond. On Tuesday, the Court dismissed the case for lack of jurisdiction because PMRS lacks Article III standing. The Court made clear that an agency’s mere denial of a petition does not constitute injury in fact for purposes of Article III standing. PMRS additionally argued that FDA could compare a PMRS application to RoxyBond during the approval process and therefore the approval of RoxyBond would alter the approval process for abuse-deterrent opioids, but the Court rejected that argument as too speculative to establish injury in fact. PMRS also could not rely on the “competitor standing” doctrine either because its NDA did not have tentative approval nor was PMRS a current competitor with RoxyBond.
Notably, this decision sets forth the premise that even if a plaintiff is the recipient of a final agency action, it may not be enough to confer Article III standing. Even having a pending NDA may not be enough to seek judicial review. While we’ll have to wait to see how this is applied beyond the narrow circumstances of this case, it could have ramifications for trade associations or public interest groups that routinely use the Citizen Petition process to try to convince FDA of their policy positions.
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