| A. Historical overview
1. Prosecuting under the FDCA
The distribution of anabolic steroids and/or human growth hormone for muscle enhancement purposes may involve conduct designed both to defraud the United States and to violate federal law. Since 1938, federal law has prohibited the distribution of anabolic steroids and/or human growth hormone outside a legitimate doctor-patient relationship. Originally, the government's principal legal claim was made under the Federal Food, Drug, and Cosmetic Act and involved allegations that individuals were distributing anabolic steroids and/or human growth hormone, both of which are prescription drugs, without a prescription. See 21 U.S.C. § 353(b)(1)(B). Pursuant to this statute, prescription drugs such as anabolic steroids and/or human growth hormone could be legally distributed only in those instances in which a physician, based upon an individualized determination of a proper course of treatment, authorizes the drug's distribution to a patient under his supervision. See Brown v. United States, 250 F.2d 745, 746-47 (5th Cir.), cert. denied, 356 U.S. 938 (1958); DeFreese v. United States, 270 F.2d 730, 733 & n.5 (5th Cir. 1959), cert. denied, 362 U.S. 944 (1960); see also United States v. Zwick, 413 F. Supp. 113, 115 (N.D. Ohio 1976). If prescription drugs are distributed outside of this relationship, then the drugs are deemed misbranded. See 21 U.S.C. § 353(b). Distribution of prescription drugs outside these restrictions has resulted in the prosecution and conviction of laypersons,[FN1] pharmacists,[FN2] and physicians.[FN3]
FN1. E.g., United States v. Shields, 939 F.2d 780 (9th Cir. 1991), superseded after remand by, United States v. Von Mitchell, 984 F.2d 338 (9th Cir. 1993).
FN2. E.g., United States v. Siler Drug Store, 376 F.2d 89 (6th Cir. 1967).
If such illegal distribution of anabolic steroids and/or human growth hormone was done with the intent to defraud and mislead either consumers or the state and federal government agencies regulating these drugs, the conduct was punishable as a three-year felony.[FN4] 21 U.S.C. § 333(a)(2); see United States v. Cambra, 933 F.2d 752, 755 (9th Cir. 1991).
FN3. E.g., DeFreese, supra; Brown, supra.
FN4. Using the Federal Food, Drug, and Cosmetic Act, the government must establish an interstate nexus. Thus, the government must prove either that any one of the components of the anabolic steroids and/or human growth hormone travelled in interstate commerce before the drug was misbranded and held for sale, see 21 U.S.C. § 331(k), or the government must establish that the individual caused the delivery for introduction into interstate commerce of the misbranded human growth hormone and/or misbranded anabolic steroids, see 21 U.S.C. § 331(a).
2. The 1988 Amendments
In recognition of the fact that illegal drug trafficking in anabolic steroids and human growth hormone was becoming larger in scope and presenting an ever-increasing health risk to young athletes, Congress addressed the issue with two amendments, first in 1988 and then later in 1990. The purpose of both of these amendments was to criminalize steroid and human growth hormone trafficking.
The first of these amendments was enacted as part of the 1988 Anti-Drug Abuse Amendments, Pub.L. No. 100-690, §§ 2401, 2403, and took effect on November 18, 1988. The 1988 Anti-Drug Abuse Amendments had two important components. The first was the creation of a new statute (codified at 21 U.S.C. § 333(e)(1)) which made the distribution of anabolic steroids illegal unless (1) it was done pursuant to the order of a physician, and (2) it was for the purpose of treating a disease. Pub.L. No. 100-690, § 2403. The second weapon that Congress added in 1988 to the government's arsenal to halt illegal trafficking in anabolic steroids and/or human growth hormone was the enactment of Pub.L. No. 100-690, § 2401. This provision, which was codified as 21 U.S.C. § 333a, gave the government the authority to seek forfeiture of property for felony crimes relating to any violations of the Federal Food, Drug, and Cosmetic Act involving anabolic steroids or human growth hormone. In pertinent part, 21 U.S.C. § 333a, provided:
Any conviction for a violation of section 303(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 333(e)), or any other provision of that Act, involving an anabolic steroid or a human growth hormone shall be considered, for purposes of section 413 of the Controlled Substances Act (21 U.S.C. § 853), a conviction for a violation of title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, if such violation of the Federal Food, Drug, and Cosmetic Act is punishable by imprisonment for more than one year.
3. The 1990 Amendments
In 1990, Congress enacted more stringent controls with higher criminal penalties for offenses involving the illegal distribution of anabolic steroids and human growth hormone. This new legislation, which was enacted as part of the Anabolic Steroids Control Act, Pub.L. No. 101-647, title XIX, §§ 1901-05, resulted in a reconfiguration of the statutory scheme regulating the distribution of both anabolic steroids and human growth hormone. The 1990 Act reclassified anabolic steroids as Schedule III controlled substances, effective February 27, 1991.[FN5] See 21 U.S.C. § 812(c) (1992). The 1990 Act also amended 21 U.S.C. § 333(e)(1) to explicitly criminalize as a five-year felony the distribution and possession, with intent to distribute, of human growth hormone "for any use . . . other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Human Services . . . and pursuant to the order of a physician . . . ."[FN6] Pub.L. No. 101-647, title XIX, § 1904 (codified at 21 U.S.C. § 333(e)(1) (1992)). The 1990 Act also provided that criminal forfeiture would be available as an additional penalty for convictions involving illegal distribution of human growth hormone under the newly amended 21 U.S.C. § 333(e)(1). See Pub.L. No. 101-647, title XIX, § 1904 (codified as 21 U.S.C. § 333(e)(3) (1992)).
FN5. Although U.S.C.A. still lists 21 U.S.C. § 333(e)(1) as prohibiting the distribution of anabolic steroids, it should be noted this provision has not been in effect since February 27, 1991.
FN6. If human growth hormone is distributed to individuals under the age of 18, the amendments increase the maximum term of imprisonment to 10 years. Pub.L. No. 101-647, title XIX, § 1904 (codified at 21 U.S.C. § 333(e)(2)).
In 1993, these provisions outlawing the distribution of human growth hormone for non-medical purposes were recodified at 21 U.S.C. § 333(f) pursuant to Pub.L. No. 103-80, § 3(e), 107 Stat. 775.
Prosecuting distribution of human growth hormone is different from virtually any other drug prosecution under the FDCA. Among other things, proof of interstate distribution of the drug is unnecessary. Additionally, the mens rea requirement for a felony is "knowing distribution" or "knowing possession with intent to distribute," not "intent to defraud or mislead."
Thus, prosecuting non-physicians for distributing human growth hormone is akin to prosecuting a narcotics case under the Controlled Substances Act. As a result, establishing liability in such cases is simpler than for other FDCA offenses. This is particularly true because the only two authorized manufacturers of human growth hormone (Genentech and Eli Lilly) have both established stringent restrictions over the distribution of their products to ensure that only physicians can gain access to the drugs. Under the current restrictions, only hospital pharmacies can order the drug; local pharmacies cannot. Thus, most non-physician cases involving the distribution of human growth hormone will involve one of three scenarios: (1) diverted human growth hormone, obtained either through theft or via a drug-dealing physician; (2) smuggled human growth hormone; or (3) counterfeit human growth hormone.
Prosecuting a physician brings other considerations into play. Because section 333(f)(1) allows physicians to distribute human growth hormone in connection with either (1) "treatment of a disease" or (2) "other recognized medical condition" which has been authorized by the Secretary of Human Services, additional evidence is necessary to prove that a physician is a drug dealer. Obtaining such evidence can be difficult. Consideration should be given to attempting "controlled buys" using undercover agents or informants. Both search warrants and grand jury subpoenas for the physician's medical files will often need to be utilized. Of course, in so doing, care must be given to protect the bona fide privacy interests of any legitimate patients the physician might have.
There is no sentencing guideline governing the distribution of human growth hormone in violation of 21 U.S.C. § 333(f)(1). See Application Note 4, U.S.S.G. § 2N2.1. If the investigation has been able to establish a pattern of fraud and dishonesty in the acquisition and distribution of human growth hormone, then a compelling argument can be made that the most appropriate guideline is the fraud guideline, U.S.S.G. § 2F1.1. Under such circumstances, the fraud table should be used by referring to value of the drugs sold. See United States v. Cambra, 944 F.2d 752, 756 (9th Cir. 1991); see also United States v. Von Mitchell, 984 F.2d 338, 340 (9th Cir. 1993); United States v. Kelly, 993 F.2d 702, 704 (9th Cir. 1993). Moreover, application of U.S.S.G. § 2F1.1(b)(4) (2-level enhancement because the offense involved conscious or reckless risk of serious bodily injury) should be sought as matter of course. This is because human growth hormone is a potentially dangerous drug, which when used by adults can lead to diseases having significant mortality rates. Its misuse in adults poses a wide array of serious side effects, including significant cardiovascular disease, irreversible enlargement of the heart, and development of polyps and malignancies of the colon.
[cited in Civil Resource Manual 15]