Here is the narrow and difficult legal standard that Sanofi has to overcome to meet its burden. Good luck, as this is not some ill thought out, put your finger to the wind, out of the blue, make it up as you go decision. The FDA's thoroughness in this decision impressed even me. This said, good attorney's can nit pick anything. However, Sanofi has to first show that it is likely to prevail before it can even get a temporary restraining order. The standard is as follows:
<<<FDA decisions about adulteration and regulation are reviewed under the APA, which states that an agency's decision should not be overturned unless it was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). We have defined the arbitrary and capricious standard as follows:
A decision is arbitrary and capricious if the agency “has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or product of agency expertise.”
O'Keeffe's, Inc. v. U.S. Consumer Prod. Safety Comm'n, 92 F.3d 940, 942 (9th Cir.1996) (quoting Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983)). Most importantly, “[r]eview under the arbitrary and capricious standard is narrow, and the reviewing court may not substitute its judgment for that of the agency.” Id. (citing Marsh v. Oregon Natural Resources Council, 490 U.S. 360, 376, 109 S.Ct. 1851, 104 L.Ed.2d 377 (1989)); ?Presidio Golf Club v. National Park Service, 155 F.3d 1153, 1160 (9th Cir.1998) (citations omitted).
In Bowen, we recently applied the arbitrary and capricious standard to a FDC Act case about whether a Class III medical device was adulterated. See Bowen, 172 F.3d at 687. “?‘Congress gave FDA sweeping discretion in determining the classification of devices and therefore in judging the safety and effectiveness of medical devices.’?” Id. (quoting Ethicon, Inc. v. FDA, 762 F.Supp. 382, 386 (D.D.C.1991)). In Bowen, the appellant challenged whether a machine that sterilizes dental handpieces was a “device” under the FDC Act's statutory definition, and whether FDA acted arbitrarily and capriciously by classifying the sterilizing machine as a Class III device subject to pre-market approval. See id. at 684.>>>
Basically, as long as the agency stayed within its wide berth of discretion, acted professionally, and applied relevant factors, the court CANNOT impose its own opinion, no matter how strongly held or what experts it uses, but MUST accept the findings of the FDA.
It is basically a process argument. Tough to see how the FDA did anything here but conduct one of its most thorough and exhaustive product analysis that it may ever have conducted. Doesn't really matter whether they got it right or wrong in the opinion of anyone else, as long as they proceeded properly and within their very wide mandate as set by law. Which as we all know is almost all encompassing, with great discretion and latitude.
I would expect some share price retracement to account for the perceived risk. The Street usually overreacts to such things, but there was no wholesale bailing after hours, so will have to wait and see how the share price goes tomorrow.
Tinker
AI
