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Tenets of Administrative Law Trump Immutable Laws of Science

By Robyn Hagan Cain on March 12, 2013 | Last updated on March 21, 2019

In 2011, the FDA approved three abbreviated new drug applications (ANDAs) submitted by Identi Pharmaceuticals for generic versions of Hill Dermaceuticals' products. Hill sued the FDA, arguing that the FDA's approval of Identi's products was arbitrary and capricious under the Administrative Procedure Act.

The district court granted summary judgment to the FDA. The D.C. Circuit Court of Appeals affirmed that decision, finding that the "basic tenets of administrative law" have a greater impact in an appeal than Hill's arguments hyperbolic references to the "immutable laws of science."

Under the Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act, abbreviated drug applications need not include all of the same clinical data as new drug applications. Instead, ANDA applicants only have to identify an approved drug and then "show that the new drug is bioequivalent to the listed drug."

FDA regulations establish that the requirement to submit data showing bioequivalence may be waived where the drug is a solution for application to the skin, has active ingredients in the same concentration and dosage as an approved drug, and "[c]ontains no inactive ingredient or other change in formulation from [an approved drug] that may significantly affect absorption of the active drug ingredient."

The FDA granted bioequivalence waivers for Identi's body oil, scalp oil, and ear drops. Hill challenged the waiver. The D.C. Circuit ruled that none of Hill's arguments had merit.

First, Hill claimed that its products are not "solutions," so waiver was not allowed under 21 C.F.R. § 320.22(b)(3). The appellate panel responded that the relevant question was whether the new drug -- not the listed drug -- was a solution. In any event, record evidence amply supports the FDA's conclusion that both products are solutions.

Second, Hill said that the FDA improperly approved Identi's scalp oil because the agency had previously stated that the scalp needed to be treated differently from other body skin for the purposes of bioequivalence. The D.C. Circuit noted that the referenced statement made clear that different testing for the scalp was needed only where the requirements of a waiver were not met. Here, the FDA reasonably determined that a waiver was warranted, so the argument was irrelevant.

Third, Hill argued that the ear drop waiver was improper because Identi omitted two fragrances that Hill had used in its own products. The D.C. Circuit found that the district court properly deferred to the FDA's technical conclusion that omission of the fragrances would have no expected effect on efficacy or safety.

Fourth, Hill complained that the FDA's approval contained sufficiently numerous and serious inaccuracies to render these decisions arbitrary and capricious. The D.C. Circuit dismissed the "inaccuracies" as "minor technical mistakes" that didn't undermine the FDA's decision.

Finally, Hill criticized that the FDA should not have approved Identi's drugs because Identi does not use the same labeling as Hill. The appellate panel laughed off that suggestion, noting that Hill's label wasn't "approved" for the listed drug, so Identi didn't need to copy Hill's statements.

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