In accordance with paragraph 13(h) of the Procedural Order of May 14, 2013,¹ claimants Apotex Holdings Inc. (“Apotex Holdings”) and Apotex Inc. (“Apotex-Canada”) (collectively, “Apotex”) respectfully submit this Supplement to their Reply on  the merits and counter-memorial on jurisdiction in support of their claims against  respondent United States of America. 

1. The documents produced by the US after April 19, 2013 further support Apotex’s case. Nothing in these documents shows that Apotex’s products were unsafe or ineffective. Instead, the contemporaneous record shows that FDA’s main concerns as to the company’s cGMP compliance were based on a series of misunderstandings not discussed with Apotex. The documents are consistent with a rush to judgment on FDA’s part – one that provided Apotex no opportunity to set the record straight before adoption of the Import Alert. 
2. In addition, the documents confirm that FDA repeatedly cited Apotex as an example of a tough new enforcement approach announced weeks before the Import Alert was adopted. As it noted at the time, FDA placed Apotex on Import Alert only two weeks after the Signet Inspection, without issuing a warning letter concerning this facility, without notice, without providing Apotex an opportunity to correct the cGMP issues raised by FDA and without taking into consideration the firm’s response either to the Etobicoke Warning Letter or the Signet Form 483 before the measure was adopted. Unfortunately, as demonstrated in the Memorial and in the Reply, FDA applied that approach to Apotex but not to its comparators with like – or more serious – cGMP violations. FDA took no enforcement action comparable to the Import Alert against those companies. 
3. As observed in the Reply, the present case does not center on whether FDA was correct or incorrect in its findings of cGMP violations.² It is not disputed that, as concerns the cGMP findings, Apotex and its comparators are in like circumstances.³ Nor is the correctness or incorrectness of FDA’s findings placed into issue by Apotex’s Article 1105 claim, which addresses the process (or absence thereof) by which FDA reached its findings, not their substance. The documents addressed in this Supplement are in many respects peripheral to the legal issues presented by the claims under Articles 1102, 1103 and 1105 of the NAFTA. Nonetheless, the documents do shed some light on the context in which the Import Alert was adopted and for this reason merit some discussion.