A good summary of FDA's argument from their MEMORANDUM IN SUPPORT OF DEFENDANTS’ MOTION TO DISMISS AND IN OPPOSITION TO PLAINTIFFS’ MOTION FOR INJUNCTIVE RELIEF, in K-V PHARMACEUTICAL COMPANY v. UNITED STATES FOOD AND DRUG ADMINISTRATION (1:12-cv-01105-ABJ):
Plaintiffs’ Complaint should be dismissed. Their claims are not justiciable. To establish standing, Plaintiffs must allege an injury that is likely to be redressed by the relief they seek. Plaintiffs cannot satisfy the redressability requirement because the declaratory and injunctive relief they seek, including an order compelling FDA to take enforcement actions and to refuse import entries of 17-HPC active pharmaceutical ingredient (API), either is unavailable as a matter of law or is not likely to redress their injury.Very bearish for KV. In order to survive, they needed an injunction forcing the FDA to eliminate competition for Makena. At a minimum, it seems like this case will drag on forever and at the very least not be resolved in KVs favor in the 1-2 month time frame that would be needed for them to avoid running out of cash. Referring to the circuit split on 353a:
Even if Plaintiffs can establish standing, FDA’s March 2011 statement is not subject to judicial review under the Administrative Procedure Act (APA) because FDA’s decisions not to take enforcement action are committed to the agency’s discretion under Heckler v. Chaney, 470 U.S. 821 (1985). Moreover, the conduct alleged - a statement expressing an intent to exercise enforcement discretion - does not state a violation of any of the sections of the Federal Food, Drug, and Cosmetic Act (FDCA) cited by Plaintiffs. Finally, this Court should refuse to grant the requested mandatory injunction. FDA’s testing of samples of compounded 17-HPC and the active ingredient failed to reveal any major safety concern. Forcing FDA to reject its enforcement priorities in favor of Plaintiffs’ commercial interests would be both inappropriate and contrary to the public interest."
"[I]n light of the complexity of taking enforcement action during this circuit split, FDA is generally prioritizing enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to compounded products that are causing harm or that amount to health fraud."Referring to the Orphan Drug Act:
"This exclusivity provision, by its plain language, does not guarantee a drug protection from competition. It applies only to bar FDA from approving certain NDAs, ANDAs, and BLAs. It does not bar FDA from approving another sponsor’s NDA or BLA for the same drug for a different indication, nor does it prevent FDA from approving another sponsor’s NDA or BLA for a different drug for the same indication. This provision makes no mention of compounded drug products."It also seems like KV has shot themselves in the foot with the lawsuit. How much effort is FDA going to put into "normal enforcement" now that they are defending this lawsuit from KV?