On July 29, 2015, the District of Maryland Judge Deborah Chasanow denied Mallinckrodt Inc.‘s (“Mallinckrodt’s”) attempt to obtain judicial review of FDA’s determination that its methylphenidate hydrochloride extended-release tablets ANDA referencing Janssen Pharmaceutical Inc.’s Concerta®(“Mallinckrodt’s ANDA”) would be reclassified as a “BX-rated” (i.e., pharmaceutically but presumed therapeutically inequivalent pending adequate information to make a full evaluation of therapeutic equivalence) product. Further, Chasanow denied Mallinckrodt’s motion to seal and its request for FDA to produce an administrative record as moot. The ruling was unsealed on August 12, 2015.

Mallinckrodt initially satisfied FDA’s July 19, 2012 biostudy requirements for generic Concerta®, resulting in a product approval on December 28, 2012. At that time, FDA provided Mallinckrodt’s ANDA with an “AB-rating” (i.e., pharmaceutically and therapeutically equivalent). But on November 12, 2014, FDA informed Mallinckrodt in a teleconference that it would reclassify Mallinckrodt’s ANDA as BX-rated pending additional data to meet a new biostudy requirement for generic Concerta® issued November 6, 2014. Mallinckrodt had not modified its ANDA since approval.

As part of its complaint, Mallinckrodt alleged that FDA’s action without an opportunity to be heard is arbitrary and capricious and “effectively takes Mallinckrodt’s methylphenidate ER tablets off the market,” calling it a “final agency action that deprives Plaintiff [Mallinckrodt] of a property right in the ANDA approval.” Mallinckrodt further alleged that FDA was required by administrative procedures required to provide notice and comment before changing its biostudy requirements for generic versions of Concerta®.

Interestingly, Mallinckrodt was provided in its November 2014 teleconference with FDA support for FDA’s changed position: that FDA has received numerous reports from FDA’s Adverse Events Reporting System (AERS) beginning in May 2013 and continuing through a sufficient number to September 2013 suggesting a possible therapeutic inequivalence with Concerta®. FDA investigated this further, finding potential equivalence issues based on multimedia dissolution testing, particularly on the later phases of a twelve-hour dose. According to Mallinckrodt, FDA said in the November 2014 teleconference that it had “’compelling’ supporting data, including case report forms, and referenced a detailed report of over 100 pages supporting [its] decision.”

Chasanow agreed with FDA that FDA’s revised biostudy requirements reflected FDA’s continued effort to evaluate the therapeutic equivalence of generic Concerta® products and does not present a case or controversy of “final agency action” that is ripe for judicial review. “FDA has broad discretion to determine whether bioequivalence has been adequately established,” Chasanow wrote. Such bioequivalence determinations do not rise to the level of regulations when, as in this case, the recommendations are part of FDA guidance, which are not binding and alternative approaches may also satisfy the bioequivalence requirements. FDA’s determination that Mallinckrodt’s ANDA will be granted a BX-rating, moreover, was provisional, pending Mallinckrodt’s submission of data satisfying the new biostudy requirements or a withdrawal of its product. As such, Mallinckrodt’s request for an administrative record was premature, because there was no final agency action or an “effective withdrawal,” as Mallinckrodt had alleged.

Chasanow further did not find FDA’s therapeutic reclassification pending additional data a due process-type “taking” or property interest. FDA did not revoke Mallinckrodt’s ANDA, Chasanow noted, and is still permitted to market its product. “The deprivation or impairment identified by Mallinckrodt is the decrease in its market share and financial losses that resulted from FDA’s reclassification of its drug’s TE [therapeutic equivalence] rating, which is not sufficiently direct deprivation of property to state a due process violation.” FDA had a duty to change the TE classification based on updated drug information, which is a duty FDA has to the public, Chasanow added. Finally, to the extent the court record included commercial confidential information, Chasanow believed the public right’s to assess this information outweighed Mallinckrodt’s conclusory assertions that release of such information would provide its competitors with an unfair competitive advantage.

This case touches upon interesting issues that we will continue to follow – when does FDA’s guidance process have the near-effect of rulemaking, and to what extent, if ever, will a court second-guess FDA’s bioequivalence determinations?