January, 2007: FDA clarifies that it is illegal to prescribe, in addition to distribute or provide GH for antiaging or athletic uses
A January 23rd, 2007 "Detention Without Physical Examination (DWPE) Alert" clearly states, perhaps more than ever before, that it is not only illegal to market, provide or distribute GH for anti-aging and athletic use, it is also illegal for doctors to prescribe it for these uses and for anyone to market it for these uses. Following, is the key text.
FDA-approved HGH can be legally prescribedfor a limited number of conditions including:
* hormonal deficiency that causes short stature in children;
* long-term treatment of growth failure due to lack of exogenous GH secretion;
* long-term treatment of short stature associated with Turner syndrome;
* adult short bowel syndrome;
* adult deficiency due to rare pituitary tumors or their treatment; and
* muscle-wasting disease associated with HIV/AIDS.
HGH has important benefits, but also serious, known risks. Among the possible long-term side effects of HGH is an increased risk of cancer, and other dangerous side effects have been reported, including nerve pain and elevated cholesterol and glucose levels. For this reason, HGH is carefully regulated in the U.S.
The cost of approved HGH products is high, averaging several hundred dollars per dose. Because of this high cost, HGH drugs have been counterfeited and unapproved HGH products are offered for sale to U.S. consumers. For example, we have encountered HGH products imported as a lyophilized powder and declared as an active pharmaceutical ingredient (API) for pharmacy compounding. Some pharmacies promote compounded HGH for anti-aging purposes. It is sold as a "fountain of youth" in longevity clinics and to build body mass, weight loss, increase libido, and gain stamina. None of these indications are in the labeling of the FDA approved products.
The agency is aware of unapproved HGH finished dosage form products being imported into the U.S. and recently noted a large increase of HGH being offered for import for pharmacy compounding. If the drug is bought from foreign sources or over the Internet, safeguards built into the U.S. drug distribution system may be bypassed, placing consumers who use HGH at higher risk.
Section 303(e) (1) of the FDCA, 21 U.S.C. 333(e) (1), prohibits knowingly distributing, or possessing with the intent to distribute, HGH for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services (HHS) under section 505 of the FDCA (21 U.S.C. 355) and pursuant to the order of a physician. The Secretary of HHS has not authorized, for example, any HGH use for anti-aging, bodybuilding, or athletic enhancement. Thus, distributing, or possessing with the intent to distribute, HGH for these uses or any other unapproved use violates section 303(e) (1) of the FDCA. A violation of section 303(e)(1) carries up to 5 years imprisonment and fines and, if the offense involves an individual under the age of 18 years of age, up to 10 years imprisonment and fines.
HGH products are new drugs and cannot be legally marketed in the U.S. without an approved application. The few HGH products that have been approved for sale by FDA are sold either in liquid form or as lyophilized powders that are labeled for reconstitution by the health care professionals who dispense them.
Accordingly, FDA considers both imported HGH lyophilized powder products and liquid HGH products to be finished dosage form drugs, not APIs. Unless these products are the subject of approved new drug applications, they violate section 505 of the FDCA, 21 U.S.C. 355, and may not be legally imported into the U.S. [Perls: THEREFORE, IT IS ILLEGAL FOR PHARMACIES TO COMPOUND Growth Hormone FOR ANTI-AGING or ANY UNAPPROVED USE]:
Some HGH marketers may claim that their HGH drug products are intended for use in pharmaceutical compounding. These drugs should be evaluated on a case-by-case basis considering the factors in FDA Compliance Policy Guide, section 460.200, and the specific prohibitions set forth in section 303(e) of the FDCA, 21 U.S.C. 333(e). The use of HGH in pharmacy compounding is addressed in more detail, below.
Some HGH marketers may claim that their HGH products are dietary supplements. FDA first approved HGH as a new drug in 1940, and HGH was not marketed as a dietary supplement, or as a food, before then. Accordingly, HGH is excluded from the definition of a dietary supplement under section 201(ff) (1) of the FDCA (21 U.S.C. 321(ff) (3) (A)) because growth hormone was an article approved as a new drug under section 505 of the FDCA (21 U.S.C. 355) before its introduction as a dietary supplement.
If the District Offices have questions concerning the importation of Human Growth Hormone (HGH) they should contact CDER/OC/DNLC immediately.
Ada Irizarry 301-827-8967
KEYWORDS: HGH, human growth hormone, somatropin; somatrem
PREPARED BY: Nawab A. Siddiqui, DIOP, 301-594-3871 William G. Nychis/CDER/OC/DNLC 301-827-8959
NEWSLETTER
NEVAD
A STATE BOARD OF MEDICAL EXAMINERS
BOARD MEMBERS:
JAVAID ANWAR, M.D.,
President
SOHAIL U. ANJUM, M.D.,
Vice President
DONALD H. BAEPLER, Ph.D., D.Sc.,
Secretary-Treasurer
MARLENE J. KIRCH CHARLES N. HELD, M.D.
JEAN STOESS, M.A. CINDY LAMERSON, M.D.
S. DANIEL McBRIDE, M.D. BENJAMIN J. RODRIGUEZ, M.D.
VOLUME 33 SUMMER 2006
BEWARE HUMAN GROWTH HORMONE
by Drennan A. Clark, J.D., Executive Director/Special Counsel
You may have seen an episode on 60 Minutes several months ago, dealing with a Las Vegas spa, where injections of human growth hormone were being used to counter the process of aging. The spa’s founder and principal owner advertised himself as a licensed physician, and promoted both the use of human growth hormone as an anti-aging treatment panacea, and his spa for anti-aging therapy.
The doctor involved is not licensed to practice medicine in Nevada (he is licensed in Illinois and New York), and does not specialize in geriatrics or cosmetic treatment. He is a radiologist.
Consumers are advised that the use of human growth hormone for anti-aging treatment or athletic enhancement is illegal. The only FDA-approved uses are for children and adults with documented growth hormone deficiencies. All other uses, even though available from many sources, are illegal.
Human growth hormone cannot be classified as a dietary supplement, and is bioavailable only in injectable form.
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. SeeBrown 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); seealsoUnited 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), supersededafterremandby, 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); seeUnited 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 mensrea 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. SeeUnited States v. Cambra, 944 F.2d 752, 756 (9th Cir. 1991); seealsoUnited 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.
November 1998
Civil Resource Manual 19
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