HILL DERMACEUTICALS, INC., Appellant v. FOOD & DRUG ADMINISTRATION, et al., Appellees.
No. 12-5182.
Unitеd States Court of Appeals, District of Columbia Circuit.
Argued Feb. 22, 2013. Decided March 12, 2013.
Nonetheless, although the government misunderstands Rhodes, the district court did not. The record shows that, at resentencing, the court did consider whether Blackson‘s willingness to testify for the defense at the subsequent trial of his friend should affect Blackson‘s own sentence. But again, unfortunately for Blackson—the judge concluded that she “d[id not] think it has an impact on how I should consider sentencing for the crimes for which Mr. Blackson was convicted beyond a reasonable doubt by a jury after hearing months and months of evidence.” Resentencing Hr‘g Tr. at 19.
This conclusion was well within the district court‘s sentencing discretion. At oral argument on this appeal, Blackson suggested that we should demand a clearer statement from the district court that it knew it had authority to consider his willingness to testify at the Gooch trial as part of his resentencing. But Rhodes indicated that a resentencing court may consider new facts that arise after a defendant‘s original sentencing, a point that Pepper underlined just two months before Blackson‘s resentencing. And the district court did consider such facts with respect to the Gooch testimony. Nothing more is required to demonstrate that the court understood the scope of its authority.
IV
Because the district court neither misunderstood its authority nor erred in exercising that authority, the judgment of the district court is
Affirmed.
Cindy J. Cho, Attorney, U.S. Department of Justice, argued the cause for appellees. With her on the brief were Stuart F. Delery, Principal Deputy Assistant Attorney General, Maame Ewusi-Mensah Frimpong, Deрuty Assistant Attorney General, and Drake Cutini, Attorney.
William D. Coston, Martin L. Saad, and David D. Conway were on the brief for intervenor Amneal Pharmaceuticals, LLC in support of appellee.
Before BROWN, Circuit Judge, and EDWARDS and SILBERMAN, Senior Circuit Judges.
Opinion for the Court filed PER CURIAM.
PER CURIAM:
Hill Dermaceuticals filed a successful new drug application with the FDA in 1988 for a corticosteroid called “Derma-Smoothe.” The application included three separate products—body oil, scalp oil, and ear oil drops. In 2011 the FDA approved three abbreviated new drug applications1 (“ANDAs“) submitted by Identi Pharmaceuticals for generic versions of Hill‘s three рroducts. Hill sued the FDA in the U.S. District Court for the District of Columbia, arguing that the FDA‘s approval of Identi‘s products was arbitrary and capricious under the Administrative Procedure Act.1 The district court granted summary judgment to the FDA, and Hill filed this appeal.
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 apрlications. Rather, ANDA applicants need only identify an approved drug and then “show that the new drug is bioequivalent to the listed drug.”
As a preliminary matter, Hill argues that the district court abused its discretion in refusing to consider 21 extra-record declarations that purportedly provide detailed technical information about Hill‘s products. But of course, it is black-letter administrative law that in an APA cаse, a reviewing court “should have before it neither more nor less information than did the agency when it made its decision.” Walter O. Boswell Mem‘l Hosp. v. Heckler, 749 F.2d 788, 792 (D.C.Cir.1984). The district court did not abuse its discretion in adhering to this well-established principle.
We have recognized a small class of cases where district courts may consult extra-record evidence when “the procedural validity of the [agency]‘s action ... remains in serious question,” Esch v. Yeutter, 876 F.2d 976, 991 (D.C.Cir.1989), but Hill‘s case does not fall within this narrow set of exceptions. Esch has been given a limited interpretation since it was decided, and at most it may be invoked to challenge gross procedural deficiencies—such as where the administrative record itself is so deficient as to preclude effective review. See Theodore Roosevelt Conservation P‘ship v. Salazar, 616 F.3d 497, 514 (D.C.Cir.2010).
Hill then presents four arguments challenging the FDA‘s decision to grant bioequivalence wаivers, but none have merit. First, appellant argues that its products are not “solutions” under
Second, Hill suggests 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. But that 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 determinеd that a waiver was warranted, so appellant‘s argument is beside the point.
Third, Hill argues that the waiver for Identi‘s ear drops was improper because Identi omitted two fragrances that Hill had used in its own products. Though these fragrances are inactive ingredients, Hill suggests that their absence would alter the drug‘s substantive effects. But this is the sort of technical, scientific question on which deference to agencies is especially warranted. The FDA reasonably concluded—after examining the makeup of Identi‘s drugs and consulting with multiple divisions within the agency—that the omission of the fragrances would have nо expected effect on efficacy or safety.
And fourth, appellant contends that the FDA‘s approval of Identi‘s abbreviated applications contained sufficiently numerous and sеrious inaccuracies to render these decisions arbitrary and capricious. But most of these alleged errors are minor technical mistakes, such as the use of a wrong applicatiоn number for an Identi product or listing an incorrect date on a prior application, and Hill develops no argument suggesting that the alleged errors resulted in prejudicial treatment or that the аgency‘s ultimate decision would have
Finally, Hill argues that the FDA should not have approved Identi‘s drugs because Identi does not use the same labeling as Hill. Specifically, the current labeling for Hill‘s produсts states: “The peanut oil used in Derma-Smoothe/FS is tested for peanut proteins through amino acid analysis which can detect the quantity of amino acids to below 0.5 parts per million.” Identi, by contrast, states merely that its products include peanut oil refined under U.S. Pharmacopeia-National Formulary (“USP-NF“) standards. Appellant suggests that this difference violates the same-labeling provision in
The key phrase in the statute is “labeling approved for the listed drug.” The FDA has concluded that Hill‘s amino-acid testing method has not been validated and has thus instructed to Hill to remove this line from its labels. The agency has instеad decided that the use of peanut oil refined according to USP-NF standards (basically, heat to 475°F for 15 minutes) is sufficient to reduce peanut proteins to safe levels. Hill‘s label is not “approvеd” for the listed drug, so Identi need not copy Hill‘s statement about a non-validated method. Moreover,
Hill‘s briefing makes a number of hyperbolic references to the “immutable laws of scienсe,” but the basic tenets of administrative law have greater impact on our decisions. The FDA‘s actions were not arbitrary and capricious, and the district court‘s grant of summary judgment is affirmed.
So ordered.