DC appeals court quashes Nostrum's suit against FDA, explaining CRLs are not final rejections

06 Jun 2022
endpts.com
Generic Drug
A Missouri-based pharma company, once at the center of a Shkreli-esque generic drug pricing scandal, just lost its chance to challenge the FDA’s complete response letter for its generic drug theophylline, which is used to treat asthma and other respiratory conditions. The court ruled that it cannot take action on the suit as there’s a “statutory barrier” to the court’s review of complete response letters because they aren’t technically final. The facts of the Nostrum Pharmaceuticals case also underscore the unfinished nature of the CRL process, the opinion explained, noting that since petitioning the court for review, Nostrum has also pressed FDA to approve its still-pending ANDA. “Because neither agency action constitutes a final rejection of the application, we lack jurisdiction to hear Nostrum’s petition and therefore dismiss it,” the opinion says . In March 2021, Nostrum sent the FDA a letter disputing the CRL’s bioequivalence conclusions while also responding to “all the other issues” that the division raised. But the court explained how Nostrum sent this letter to FDA for the express purpose of “stav[ing] off” an end to agency proceedings as inaction by an applicant for a year after the issuance of a CRL may be construed as a “request by the applicant to withdraw the application.” “Those measures would make no sense if the FDA had already issued an order ‘refusing * * * approval of [the] application[.],'” the court said. The challenge for theophylline is that it’s a narrow therapeutic index drug, meaning, according to the court, “[t]here is little separation between effective concentrations and concentrations associated with serious toxicity[,]” and “[s]ub-optimal concentrations lead to severe therapeutic failure.” For these types of generics, the FDA often requires the submission of more rigorous bioequivalence studies, including a study with a fully replicated crossover design. That kind of design requires subjects to receive two doses, one each of the test and the branded drug, so that researchers can measure the difference in rate and the extent of absorption between the two doses, administered at different times to the same subject. The FDA and Nostrum went back and forth on the requirements and during a second reconsideration request, Nostrum petitioned the DC court to review the CRL, which has now concluded with this dismissal. Nostrum previously fell into the spotlight in 2018 after the company had to defend its decision to almost quadruple the price of the generic antibiotic nitrofurantoin, which can treat and prevent urinary tract infections. In an interview with the Financial Times , Nirmal Mulye, Nostrum’s CEO, said he had priced the generic according to market dynamics as the company making the brand version also increased its price. “I think it is a moral requirement to make money when you can . . . to sell the product for the highest price,” he told the FT.
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