veral arguments in favor of FDA granting NCE exclusivity, including: (1) that the intent of the Hatch-Waxman Amendments is to reward sponsors that develop and obtain approval of NCEs, and the denial of NCE exclusivity for PREPOPIK is inconsistent with the legislative history of the law; (2) that the need to reduce unnecessary and duplicative research (and avoid unethical research), as evidenced in FDA’s interpretation of FDC Act § 505(b)(2) and policy concerning hybrid New Animal Drug Applications, is consistent with an award of NCE exclusivity for PREPOPIK;(3) that FDA’s application of NCE exclusivity to other combination drugs under the Agency’s “umbrella policy” (noted above) shows “that FDA does, in effect, grant five-year exclusivity protection to drugs that are combinations that contain previously approved active ingredients, so long as the single active ingredient drug containing the novel active ingredient is approved first;” and(4) that FDA’s so-called “Animal Efficacy Rule,” 21 C.F.R. § 314.610 (drugs), § 601.91 (biologics), under which FDA can rely on evidence from animal studies to provide substantial evidence of effectiveness when it is unethical or unfeasible to conduct human efficacy studies to obtain approval of a countermeasure product, supports “the position that FDA takes public health objectives into consideration when interpreting statutory language.” Accordingly, says Ferring, because the company “was ethically barred from conducting a study of single ingredient sodium picosulfate without including the other ingredients magnesium oxide and anhydrous,” “FDA should treat Ferring’s situation similar to those cases where FDA approved a drug product and granted exclusivity based on animal studies.”

Although given relatively little attention since it was promulgated, the Animal Efficacy Rule creates a new regulatory paradigm for measuring efficacy by permitting FDA to approve drugs and biologics for counterterrorism uses based on animal data when it is unethical or unfeasible to conduct human efficacy studies. Under the Animal Efficacy Rule (21 C.F.R. § 314.610, drugs; § 601.91, biologics), FDA can rely on the evidence from animal studies to provide substantial evidence of effectiveness only when:1. There is a reasonably well-understood pathophysiological mechanism of the toxicity of the CBRN substance and its prevention or substantial reduction by the product;2.