Many physicians who prescribe Human Growth Hormone (“hGH”) focus on the legal risks imposed by the Federal Food, Drug, and Cosmetic Act (“FDCA”) because that law imposes felony sanctions on the distribution of hGH for off-label purposes. However, state medical boards have been more aggressive than the federal government in taking action against physicians for prescribing hGH for such purposes. Because the legal terrain has changed over the last few years, physicians should exercise great caution when prescribing hGH, especially for adult hGH deficiency (“AGHD”). This article briefly summarizes the diverse status of hGH in the states and provides a few examples of actions state medical boards have taken against physicians for prescribing hGH.
The author has conducted research in virtually all 50 states and has found that the majority of states have specifically regulated hGH more strictly than other drugs. Sometimes the specific statutory or regulatory sections are difficult to find among the morass of drug laws. If a physician wants to find the legal status of hGH, wants to know if any drug is a controlled substance, or if a drug has a special classification, the most likely place to find such information is in: (i) the state controlled substances act (or rules); (ii) the state medical practice act (or rules); (iii) the state equivalent of a food and drug act (or rules); or (iv) the state pharmacy practice act (or rules). The following are a examples of how a few states regulate hGH.
• In Idaho, hGH is classified as a schedule IV controlled substance.
• Washington State law defines the term “steroids” to include human growth hormones. The law prohibits prescribing or administering “steroids” “for the purpose of manipulating hormones to increase muscle mass, strength, or weight . . . without a medical necessity to do so.”
• Florida law prohibits prescribing of hGH “for the purpose of muscle building or to enhance athletic performance.”
• Oklahoma law states: “A valid medical purpose for the use of anabolic steroids or human growth hormones shall not include bodybuilding, muscle enhancement or increasing muscle bulk or strength of a person who is in good health . . .” Violation is a felony punishable by three years imprisonment in the State Penitentiary.
Importantly, state medical boards have been sanctioning physicians for prescribing hGH without performing a stimulation or challenge test. These examples show how risky prescribing hGH without complying with traditional means for diagnosing AGHD can be.
• Kansas—The Board of Healing Arts concluded:
In the diagnosis and treatment of adult growth hormone deficiency, a provocative test is required. The standard of care requires insulin induced hypoglycemia or insulin tolerance test. Arginine combined with growth hormone releasing hormone also meets the standard of care. Growth hormone releasing hormone used alone does not meet the standard of care.
• Oregon—The Oregon Medical Board ruled:
In prescribing hGH to adults, the standard of care demands that the patient have a growth hormone deficiency, a diagnosis that is confirmed by stimulation test or evidence of a traumatic brain injury affecting the pituitary, or evidence of pituitary disease and loss of function. There are no approved applications or indications for using hGH for anti-aging, fat reduction or sleep improvement purposes in adult patients.
• Washington—The Medical Quality Assurance Commission stated:
The standard of care for diagnosing adult growth hormone deficiency requires first, that the physician have a high index of suspicion that the patient has growth hormone deficiency (for example the patient discloses a history of having a profound head trauma or brain tumor with radiation). Second, the physician must obtain an IGF-1 (insulin like growth factor) level and then perform the provocative (or stimulation) test. The stimulation test is required unless the patient has deficiencies in at least three other hormone levels or the patient has a history of childhood growth hormone deficiency. Third, if growth hormone deficiency is determined as outlined above, the physician must look for the underlying cause.
These case are meant only as examples of how state medical boards have treated physicians who prescribed hGH without a stimulation test. Accordingly, whether or not federal law requires a stimulation test, a medical board can impose severe sanctions against a license to practice medicine even if the physician believed in good faith the patient suffered from AGHD.
The prescribing of hGH for adults continues to be a practice conducted in a changing and risky legal environment.
William J. Stilling, R.Ph., M.S., J.D., is a shareholder in, and chairs the Health and Life Sciences Practice Group at, the law firm Parsons, Behle & Latimer, which has offices in Salt Lake City, UT and Las Vegas and Reno, NV. He is also an associate professor (clinical) in the Department of Pharmacotherapy at the University of Utah College of Pharmacy, where he has taught courses in drug and pharmacy law and ethics for some twenty years. He may be contacted at firstname.lastname@example.org.
This article is for educational purposes only and is not intended to establish an attorney-client relationship between the author and any reader. This article should not be relied on as legal advice. Anyone needing legal advice should engage an attorney.