Court Opinion

ID: 9475827
Source: CourtListenerOpinion
Date Created: 2023-08-05 05:39:27.567465+00
Date Added: 2024-06-11T17:44:57.768371
License: Public Domain

*295NATHANIEL R. JONES, Circuit Judge,
concurring in part and dissenting in part.
The majority opinion affirms the district court’s decision to enjoin the distribution of certain animal drugs on the ground that the drugs are misbranded because they are not sold in compliance with 21 C.F.R. § 201.105 (1986). For the reasons discussed below, I disagree and would reverse the judgment of the district court. I do, however, concur in Part III of the majority opinion, where the majority affirms the district court’s ruling requiring a written order from a licensed veterinarian in order to distribute the challenged drugs.
As discussed in the majority opinion, the district court’s injunction covered sixteen drugs falling into three categories. I will first address the appropriateness of the injunction placed on the fourteen New Animal Drugs. Next, I will discuss the injunctions placed on the two other drugs, Calphosan B-12 injectable and epinephrine.
A.
The majority holds that the FDA can “determine that approval of an NAD with labeling, restricting resale of the drugs only upon a licensed veterinarian’s order, renders that NAD subject to 21 C.F.R. § 201.105 and the misbranding provisions without requiring the FDA to demonstrate the toxicity of the drugs in a misbranding action.” (Maj. op. at 292) (emphasis added). In my view, it is improper to allow the government to shortcut the proof necessary to show the applicability of section 201.105 to these drugs.
The government did not attempt to show directly that these drugs are ones which “because of toxicity or other potentiality for harmful effect, or the method of [their] use, [are] not safe for animal use except under the supervision of a licensed veterinarian,” which is the factual predicate for coverage by section 201.105 as stated in the regulation. Rather, it argued that the drugs fall within section 201.105 solely because they are required to. bear the cautionary label as part of their approval as New Animal Drugs. Essentially the government’s position is that by virtue of bearing the cautionary label for New Animal Drug purposes these compounds have achieved the status of “prescription animal drugs” 1 and, by that fact alone, they fall within section 201.105 coverage. I find nothing in the statutes or regulations that prescribes this reasoning and I cannot accept it per se. I think we must instead determine whether the findings necessarily made during the NAD approval process, and which resulted in a requirement that these drugs bear the cautionary label, collaterally establish the factual predicate of section 201.105 that the drug is unsafe for use without veterinary supervision.
A New Animal Drug is defined as an animal drug that is
(1) ... not generally recognized, among experts qualified ... to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; ... or (2) ... [which] has become so recognized but which has not ... been used to a material extent or for a material time under such conditions____
21 U.S.C. § 321(w) (1982) (emphasis added). Clearly nothing in this definition establishes that, merely by being an NAD, a drug is unsafe for use without veterinary supervision under section 201.105. The most this definition establishes is that the drug is not recognized as safe as labeled.
The introduction into interstate commerce of an NAD is prohibited by the Act unless an NAD application has been approved for the drug, and the drug and its labeling conform to the application. 21 U.S.C. §§ 331(a), 351(a)(5), 360b(a)(l) (1982). A manufacturer who seeks NAD approval for a drug must submit, as part of the *296application, reports of investigations of the safety and effectiveness of the drug and “specimens for the labeling proposed to be used for such drug.” 21 U.S.C. § 360b(b)(l) & (6). There are no specific standards that the labeling must meet, but the Secretary is directed to refuse approval of the application if the reports submitted do not show that the drug is safe for use as directed in the proposed labeling. 21 U.S.C. § 360b(d).
The approved application for each of the fourteen NAD’s in this case provides that the drug carry the cautionary label. Under the approval scheme outlined above, however, the approval of these applications does not amount to a finding by the Secretary that these drugs are unsafe without such a label for two reasons. First, because labeling is proposed initially by the applicant, the Secretary has only to consider whether such labeling is sufficient, not whether it is necessary. The government admits that more than half of all approved NAD applications do not provide for the cautionary label. The Secretary does not decide what the label should contain, only whether the proposed label is sufficient. It is possible that the applicant for each of these NAD's submitted labeling containing the cautionary label in order to help ease approval, while the Secretary might have approved the drug without the cautionary label if it had been so submitted. Thus, all that can be presumed from the NAD application approval is that the drug is safe with the cautionary label; it does not follow that the label is necessary to make the drug safe.
Second, even if the Secretary had specifically required that these drugs bear the cautionary label, the factual prerequisites of that conclusion are not necessarily the same as those for section 201.105. Assuming that the Secretary has approved these NAD’s only if they carry the cautionary label, the reasons for that decision could have been because, at the time of approval, (1) the tests were insufficient to establish whether or not the drug was safe for lay use, (2) the tests although adequate, were inconclusive, or (3) the tests in fact showed that the drugs were unsafe except under supervision of a veterinarian. See generally 21 U.S.C. § 360b(d). Section 201.105 requires an affirmative showing that a drug is unsafe for use without veterinary supervision. Only one of several grounds for the Secretary’s decision on a NAD approval would establish this required showing.
The collateral use of the NAD status of these drugs as proof that they are unsafe under section 201.105 thus relies on two possibly invalid assumptions: first, that the Secretary actually considered whether or not the drugs required the cautionary label and, if so, second, that the decision was based on a finding that the drugs were in fact unsafe without the label. Additional facts about the history of the NAD application approval of each of these drugs are necessary in order to validate these assumptions, but have not been presented. The district court accepted the government’s argument, and its ruling that the New Animal Drugs are covered by section 201.105 was based solely on the improper collateral use of the NAD application approval. Thus, there was no showing that the drugs are in fact unsafe for use without veterinary supervision. Therefore, I would vacate the injunction as to the fourteen drugs.
B.
The district court stated that the issue before it with regard to Calphosan B-12 was “whether the unapproved animal drug ought to be considered a new animal drug”; that issue, according to the court, turned on whether the drug should be sold only to or on the order of a licensed veterinarian. Both statements are incorrect. First, because many NAD’s are approved without the cautionary label, the need for veterinary supervision is not necessary or sufficient for NAD status. Secondly, and more importantly, NAD status does not establish that the drug is unsafe under section 201.-105. The government argues that, regardless of these errors, the trial court’s find*297ing — that Calphosan should be sold only on the order of a veterinarian — is sufficient to establish the predicate finding required by 201.105. I disagree.
The only evidence considered by the district court and referred to by the government concerning the safety of Calphosan was contained in the affidavit of Dr. Vitolis Vengris and the hearing testimony of Dr. Arthur Aronson. Dr. Vengris, a veterinarian who evaluates drugs for the FDA, stated that Calphosan is a vitamin supplement and that a diagnosis that the supplement is needed can be made only by a veterinarian with laboratory tests. Unneeded use of the drug, Dr. Vengris stated, “would be wasteful and costly to the owner,” and injections “might needlessly expose the animals to possible infections.” Dr. Aronson stated only that complex laboratory tests are required to determine if the drug is needed. Neither of these statements go to the finding required by section 201.105: “because of toxicity or other potentiality for harmful effect, or the method of its use, [the drug] is not safe” for use without veterinary supervision. It is not enough that a veterinarian is needed to determine whether the drug is indicated; the regulation is concerned with whether harm will result from unsupervised use. Neither doctor stated that the drug is harmful. Dr. Vengris’s statement about the risk of infection is ambiguous. The concern may be based only on the fact that the drug is injected. It does not appear to be the Secretary’s position that injected drugs are conclusively unsafe under section 201.105, for at least one drug, epinephrine, is allowed to be sold over the counter in 10-mil-liliter vials for administration by injection. See 21 C.F.R. § 500.65. This ambiguous statement is not enough to support a finding that the drug is unsafe under section 201.105, and I would vacate the injunction as it relates to Calphosan B-12 as well.
C.
The drug epinephrine is governed by its own regulation. That regulation provides that epinephrine can be sold without a prescription in dosages of 10 milliliters or less. 21 C.F.R. § 500.65 (1986). The government claimed that the defendants dispensed this drug in 30-milliliter vials. The district court ruled, however, that, for lack of evidence, the government was not entitled to summary judgment on the question of whether section 500.65 was violated, and therefore an injunction could not issue. The court then issued a declaratory judgment that epinephrine was not to be sold in excess of 10-milliliter dosages, citing the declaratory judgment statute, 28 U.S.C. § 2201 (Supp. III 1985).
In essence the court has done no more than declare that section 500.65 applies to the drug and that it prohibits sales in dosages of over 10 milliliters without a prescription. The defendants do not challenge the regulation itself. Consequently, there was no controversy about the issue that the court decided. In absence of an actual controversy, declaratory relief is not proper. See 28 U.S.C. § 2201(a); Jervis B. Webb Co. v. Southern Systems, Inc., 742 F.2d 1388, 1399 (Fed.Cir.1984). Therefore, I would also vacate the order as it relates to epinephrine.

. Although the government has used the term "prescription animal drugs" in arguments before the district court and throughout its brief, the phrase does not appear in the statutes or regulations. For this reason, and because the phrase supports the government’s position through labeling rather than analysis, I do not adopt it.