Judicial review of a decision not to issue a NOC; 2009 FC 452; aspirin; May 5, 2009

Apotex brought a judicial review of the Minister’s refusal to issue a NOC regarding its version of aspirin. The Court dismissed the application.

Apotex was issued a Notice of Non-Compliance (“NON”) during the review process on the basis of some data deficiencies in one of its studies. In response to this NON, Apotex argued that the problems did not lie with its product but rather with the reference product that it was using. The Minister did not agree with Apotex’ arguments and determined that Apotex’ ANDS was withdrawn without prejudice to its right to re-file. Apotex asked for a reconsideration, asserting that its product was safe and that a failure to prove bioequivalence was not fatal to the application. The Minister upheld his original decision.

The Court found that the Food and Drugs Act requires proof of safety and efficacy to the Minister’s satisfaction on a reasonable basis. In order to assist with this satisfaction, the Minister has issued guidelines regarding bioequivalence, which do allow of exceptions where justified. The Court further held that the Minister had clearly stated his concerns with Apotex’ explanation of the bioequivalence issue and that Apotex was given every opportunity to submit new or better evidence and submissions but rather chose to merely reiterate the same arguments.

The Court also held that it is not unreasonable for the Minister to demand compliance with the guidelines in the absence of a clear indication that an alternative approach is justified.

The Minister had included lengthy and detailed reasons about his concerns. In particular, the Minister did not accept Apotex’ bare statement that the deficiencies in the bioequivalence data was the result of a defect in the reference drug. Apotex had not submitted sufficient evidence to satisfy him that this was indeed the problem. As in the end there was a difference of opinion between the Minister and Apotex, it was not the Court’s role to resolve that difference. It is sufficient that the Minister’s opinion or lack of satisfaction was rationally based and adequately explained.

The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2009/2009fc452/2009fc452.html