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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
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780 (9th Cir. 1991), superseded after remand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).
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 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.
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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