District Court Rules in Favor of FDA in Amgen Pediatric Exclusivity Case

Regulatory NewsRegulatory News | 26 January 2018 |  By 

The US District Court for the District of Columbia on Friday ruled in favor of the US Food and Drug Administration (FDA) in a case that deals with how biopharma companies adequately respond to requests from the agency in conducting pediatric trials and winning additional exclusivity.

The lawsuit, which legal experts said would have undermined FDA authority if the agency had lost, was brought by Amgen after FDA issued a written request asking the company to conduct pediatric studies on its calcium reducer Sensipar (cinacalcet hydrochloride).

FDA found that Amgen failed to complete one of the studies and concluded that the studies did not “fairly respond” to the agency’s written request, thus denying Amgen’s request for pediatric exclusivity.

“With respect to Amgen’s arbitrary and capricious claim, the Court, accordingly, will grant summary judgment to the FDA in part and to Amgen in part, and will remand the matter to the FDA for further consideration of its Ortho Tri-Cyclen decision,” the decision from Friday reads.

Amgen said in a statement to Focus: "The Court has remanded the matter back to the FDA, in part, to address whether a prior FDA decision granting pediatric exclusivity to another company’s product is consistent with its decision denying pediatric exclusivity for Sensipar.  We look forward to the FDA’s further review of this issue. If the remand does not result in Amgen obtaining pediatric exclusivity for Sensipar, Amgen will appeal."

Case and Decision

According to the decision, Amgen contended that FDA’s granting of pediatric exclusivity for Bristol-Myers Squibb’s Orencia (abatacept) and Johnson & Johnson’s Ortho Tri-Cyclen (ethinyl estradiol; norgestimate) are inconsistent with its denial for Sensipar, and that the agency failed to “provide a legitimate reason” for the discrepancies.

“As an initial matter, the Court is unconvinced that the FDA, without explanation, applied a more onerous standard in rejecting Amgen’s studies than it applied in accepting the studies submitted by Orencia’s sponsor,” the decision says, explaining that FDA “granted pediatric exclusivity because the ‘overall data’ from the studies BMS conducted ‘provided a sufficient safety database to draw supportable conclusions about the drug’s safety in the relevant pediatric age groups’ and ‘was sufficient to label the product for pediatric use.’

“For Ortho Tri-Cyclen, however, Amgen has a point,” the decision says. “In its reconsideration decision for Sensipar, the FDA distinguished the agency’s grant of exclusivity for Ortho Tri-Cyclen on the ground that the studies conducted by Ortho Tri-Cyclen’s sponsor, Johnson & Johnson, met all of the terms of the written request. As Amgen argues, however, it is—at best—unclear from the administrative record whether that premise is correct.”

For this reason, the decision says: “The case is remanded to the FDA for the limited purpose of addressing whether the agency’s prior decision granting pediatric exclusivity for Ortho Tri-Cyclen is consistent with its decision denying pediatric exclusivity for Sensipar and, if not, whether there is a reasoned explanation for the disparate outcomes.”

The court also weighed in on what was explained on FDA's website, adding: “The fact that the FDA subsequently applied a more generous test than the one articulated on its website could not have unfairly surprised Amgen [italics are from the decision]. Amgen would hardly be better off if the FDA had relied solely on the test alluded to on its website. The Court, accordingly, will grant the FDA summary judgment on Amgen’s APA [Administrative Procedure Act] claim and due process claim based on a purported lack of ‘fair notice.’”

The FDA win could mean generic versions of Sensipar hit the US market as early as March, Jeanie Kim, a research scholar at Yale Law School, told Focus in November.

Opinion and Order


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy