PEG 3350 Rx ANDA Holder Gets Things Moving in the D.C. Circuit

May 7, 2018By Sara W. Koblitz

On April 27, 2018, Petitioners Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. filed a Petition for Review in the United States Court of Appeals for the District of Columbia Circuit. The Petition seeks review of a final FDA order published in the Federal Register on April 2, 2018 (the “Order”). The Order denied requests for a hearing and withdrew approval for ANDAs for prescription polyethylene glycol 3350 (PEG-3350). The Order was initially effective May 2, 2018 but was stayed by FDA in response to several petitions for stay to the Agency. Currently, the Order goes into effect on November 2, 2018 – but FDA may not have the final say on this issue. Breckenridge/Nexgen’s asks the D.C. Circuit to set aside the Order as clearly erroneous, arbitrary and capricious, an abuse of discretion, and not supported by substantial evidence.

The Petition for Review is not a surprise. Breckenridge/Nexgen was one of several Rx ANDA holders participating in the Agency proceedings. Additionally, it and the other Rx ANDA holders had included in their petitions for stay to the Agency arguments that a stay was required to permit judicial review.

While FDA granted a stay until November 2, 2018, the Agency rejected the Rx ANDA holders arguments that a stay was required under 21 U.S.C. § 10.35 (e), because the criteria in (e)(1)-(4) were met.. Instead, FDA reasoned that the Agency petitioners had established that a stay was “in the public interest and in the interest of justice,” and therefore a discretionary stay was warranted—but not required. Breckenridge/Nexgen challenge both FDA’s Order and FDA’s stay determination.

Because a Petition for Review only starts the process for judicial review, it does not set forth the substance of the arguments that Breckenridge/Nexgen will make to the D.C. Circuit. That said, the Agency proceedings have been pending for some time, so the arguments are not unfamiliar to dedicated FDA Law Blog readers (indeed, we blogged on these issues here, here, and here). For those of you who need a refresher on the regulatory history of laxatives, here’s a quick recap: in April 2007, FDA approved an NDA for an Rx-to-OTC switch for MiraLax. Five ANDAs based on MiraLax as the RLD had already been approved, so FDA issued a letter to the ANDA holders explaining that FDA believes their prescription products, which bear the “Rx only” symbol, are misbranded and may not be lawfully marketed. To lawfully market PEG-3350, according to the FDA letter, the ANDA holders must file new ANDAs referencing the OTC version of MiraLax and update the labeling to OTC labeling. FDA published a Notice of Opportunity for a Hearing in the Federal Register on October 24, 2008 (73 Fed. Reg. 63491) proposing to withdraw approval of the prescription PEG 3350 ANDAs. Four ANDA holders submitted timely requests for a hearing and supporting evidence, but FDA denied a hearing in both its proposed order of May 2014 and its final order of April 2018.

In a joint Petition for Stay at the agency level, Breckenridge/Nexgen argued that the final order irreparably harms their business and should be vacated. They explain that there is a meaningful difference between the Rx and OTC versions of PEG-3350 – duration of use, as well as reimbursement – and raise procedural errors and misstatements during the administrative process. Because the Order refused to consider all information submitted in 2014 and did not address Breckenridge/Nexgen’s arguments regarding outstanding factual issues with respect the scope of the Rx-to-OTC switch, those arguments may very well be made before the D.C. Circuit. Two Rx ANDA holders also filed petitions for stay with the Agency. Our firm represented one of those Rx ANDA holders.

As of the writing of this post, no briefing schedule has been set. The court has set May 31, 2018 as the date for Petitioner’s  procedural motions.