Opinion ID: 388200
Heading Depth: 2
Heading Rank: 2

Heading: Misbranding Under Section 502(f)(1)

Text: 31 We now turn to the second requirement of section 301(k) in the context of this case: the drug at issue must have been misbranded. In order to establish that Dr. Evers misbranded Calcium EDTA, the government relies on section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). As discussed above, that section deems a drug to be misbranded unless its labeling bears ... adequate directions for use. In United States v. Articles of Drug, 625 F.2d 665 (5th Cir. 1980), we considered and upheld the FDA's interpretation of this provision. That interpretation begins with 21 C.F.R. § 201.5 (1980), which defines adequate directions for use as directions under which the layman can use a drug safely and for the purposes for which it is intended. The intended use of the drug is the objective intent of the persons legally responsible for the labeling of the drug, and may be determined, for example, by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. 21 C.F.R. § 201.128. Since Dr. Evers clearly intended to use Calcium EDTA for the treatment of arteriosclerosis, these provisions would seem to require him to provide adequate directions in lay terms to his patients for the use of Calcium EDTA in the treatment of arteriosclerosis. However, Calcium EDTA is a prescription drug. 15 The FDA insists that since a prescription drug by definition can be used only under a physician's supervision, see 21 U.S.C. § 353(b)(1), it is impossible to provide adequate directions for use to a layman; we accepted this interpretation in Articles of Drug, supra, 625 F.2d at 673. Thus, since Calcium EDTA is a prescription drug, there is no conceivable explanation which Dr. Evers could have given to his patients which would have complied with section 502(f)(1)'s requirement of adequate directions for lay use. 32 However, this does not mean that drug distributors misbrand each prescription drug which they hold for sale, for the statute provides for two important exceptions to section 502(f)(1) of the Act. In the first place, the section itself authorizes the FDA to create a regulatory exemption. See supra at note 13. The FDA has exercised this authority by creating an exception for prescription drugs. See 21 C.F.R. §§ 201.100, 201.115. In order to qualify for the prescription drug exception under these regulations, the drug's labeling must meet a number of specific full disclosure requirements. The labeling must include, for example: certain information regarding dosage, administration, and the drug's active ingredients; a warning that the drug cannot lawfully be dispensed without a prescription; an identifying number from which one may determine the manufacturing history of the particular package of the drug; a statement directed to the pharmacist specifying the type of container to be used in dispensing the drug; and, if the drug is a new drug within the meaning of the Act, a label which has been approved by the FDA pursuant to a new drug application under the Act. If these extensive requirements are met, the drug is completely exempt from the reach of section 502(f)(1) of the Act, and the distributor of the drug therefore need not provide adequate directions for use to the layman. 33 In the second place, the statute itself provides for an exception in section 503(b)(2) of the Act, 21 U.S.C. § 353(b)(2). This section states that if certain basic information is provided on the label a prescription drug shall be exempt from most of the requirements of section 502 of the Act, including that of section 502(f)(1). While the requirements of this section are somewhat more lenient than those of the regulatory exception, it provides a much narrower protection for the distributor of the drug, for it exempts the provisions of section 502 of the Act only at the point at which the drug is actually prescribed and dispensed by a licensed physician. See United States v. Articles of Drug, supra, 625 F.2d at 674; United States v. An Article of Drug ... Amodril Spancap, 1975 Food Drug Cos.L.Rep. P 38,009 at 38,035 (S.D.Fla.1974). The regulatory exemption, on the other hand, protects any person who holds the drug for sale at any point in the distribution process. 34 A two-fold scheme emerges from section 502(f)(1) when it is read in the context of the FDA's interpretation of the adequate directions for use requirement and of the regulatory and statutory exceptions to that requirement. If the drug is a non-prescription drug, the distributor must provide adequate directions in lay terms to the patient himself. But if the drug is a prescription drug, as is Calcium EDTA, the distributor must provide the information which is required by the regulatory or statutory exception to the statute, for it is impossible for the distributor to adequately explain a prescription drug to a layman. Thus, neither prescription nor non-prescription drugs can meet the terms of the statute by providing such adequate directions for use as are required for the other type of drug. 35 The purpose of this scheme is, in brief, to require that adequate information be provided to the person who must decide whether and how to administer the drug. Where non-prescription drugs are involved, the adequate directions for use requirement insures full disclosure to the layman purchasing the drugs for self-treatment. But prescription drugs depend for their safety and effectiveness on the professional judgment of a licensed physician. Accordingly, the prescription drug exceptions to the adequate directions for use requirement contain conditions requiring adequate information for prescribing doctors. As the FDA has itself explained in a notice of proposed rule making: 36 The primary objective of prescription drug labeling is to provide the essential information the practitioner needs to use the drug safely and effectively in the care of patients. 37 40 Fed.Reg. 15392 (1975) (emphasis added). The distributor of a non-prescription drug must provide adequate information for use by a layman, for patients are allowed to administer those drugs without the advice of a physician. The distributor of a prescription drug, however, must provide adequate information to the prescribing physician in accordance with the specific conditions of the statutory or regulatory exceptions to section 502(f) (1), for it is the physician who bears the responsibility for dispensing the drug. See D. A. Kessler, supra, at 742, 747; H. A. Toulmin, Jr., A Treatise on the Law of Foods, Drugs & Cosmetics § 24.12 at 576 (2d ed. 1963). 38