Human
Growth Hormone/Steroids Statutory Overview
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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 distributedonly 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States v. Shields, 939 F.2d 780 (9th Cir. 1991), superseded after remand by,United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).
FN3. E.g., DeFreese, supra; Brown, supra.
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).
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.
B.Practical Considerations
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 rearequirement 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) smugg
led 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.
C.Guidelines Considerations
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]
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