Opinion ID: 388200
Heading Depth: 2
Heading Rank: 3

Heading: Putting Together the Two Elements of Section 301(k)

Text: 39 The government argues that Dr. Evers' prescription and promotion of Calcium EDTA for the treatment of circulatory disorders meets both of the above requirements of section 301(k) of the Act. In the first place, the government contends that Dr. Evers held (Calcium EDTA) for sale when he maintained a supply of the drug for use on his own patients at the Ra-Mar Clinic. To support this position, the government relies on cases, cited in part III(A) of this opinion, which did indeed hold that a doctor who had held drugs for use in his practice had held those drugs for sale within the meaning of the Act. In the second place, the government contends that Dr. Evers misbranded Calcium EDTA within the meaning of section 502(f)(1) of the Act by failing to provide adequate directions for use either in appropriate lay terms or according to the disclosure requirements of either exemption for prescription drugs. It is undisputed that Dr. Evers did in fact fail to provide adequate directions for either lay or professional use; Dr. Evers does not contend that his booklets contained adequate directions for lay use within the meaning of the regulations, and he does not appear to have made any attempt to meet the terms of either the regulatory or the statutory exception for prescription drugs. 40 When each of the two elements of the offense with which Dr. Evers is charged is examined individually, Dr. Evers does indeed seem to have violated the statute. A different picture emerges, however, when the two elements are considered together. Since Calcium EDTA is a prescription drug, the FDA can establish an act of misbranding under section 502(f)(1) of the Act only by proving that Dr. Evers did not provide adequate information for use by physicians, as is required by the exceptions to that section. The information provided by Dr. Evers to his patients is irrelevant to the question at hand, for according to FDA regulations there is no information which could have been provided about this prescription drug which would have constituted adequate directions for (lay) use. However, the government argues that Dr. Evers held (Calcium EDTA) for sale within the meaning of section 301(k) because he maintained a supply of the drug for use on his own patients ; the government does not contend that Dr. Evers was distributing Calcium EDTA to other licensed physicians. The government therefore must find itself in an awkward position: while the misbranding violation it urges is based on Dr. Evers' failure to provide adequate information to licensed physicians, it seeks to include his actions within the reach of section 301(k) of the Act by virtue of his distribution to patients. 41 The requirement which the FDA seeks to impose is nonsensical. Since Calcium EDTA is a prescription drug, the misbranding provision under which Dr. Evers was charged requires him to provide adequate information for use by prescribing physicians. However, Dr. Evers was the only physician who used the Calcium EDTA in question. The government's application of the statute may therefore be reduced to the following proposition: Dr. Evers did not provide adequate information to himself. It is doubtful at best that this interpretation was intended by the drafters of the statute. 42 In more specific terms, the government's interpretation of the Act breaks down over its use of the phrase held for sale after shipment in interstate commerce. Although Dr. Evers was holding Calcium EDTA for sale in the sense that he was distributing it to his own patients, he was not holding it for sale to physicians. Section 301(k) of the Act cannot reasonably be read to require a physician who is holding a drug for sale only to patients to provide adequate information to physicians to whom he is not distributing the drug. We think it clear that a single doctor may be holding drugs for sale to one group of purchasers but not to another. If the doctor is not holding the drug for sale to the party to whom he owes a statutory obligation of full disclosure (in this case other prescribing physicians), then it makes no sense to impose the requirements of the statute. No legitimate purpose is served when a statutory provision requiring disclosure to one particular group of purchasers is invoked on the basis of sales made to a different group. Since Dr. Evers was holding Calcium EDTA, a prescription drug, for sale only to his patients, and since section 502(f)(1) of the Act does not require any disclosure to patients regarding prescription drugs, we conclude that Dr. Evers did not violate section 301(k) of the Act. 16