The FDA has been in the news lately. For those returning from two month news-free National Geographic vacation in Antarctica, a compounding pharmacy in Massachusetts was supplying vials of preservative free methyl-prednisolone for epidural injections and much more. Some of these vials were tainted with fungus. Many people got sick. Some died. The FDA does not typically have any statutory authority over such compounding pharmacies. But, anything related to pharmaceuticals gone bad gets the attention of the FDA. So, it took us a while to get an answer from the FDA about a completely unrelated item – also in the news, but less so.

 

The cycling world went public with evidence about performance enhancing ‘doping.” Doping is defined broadly, and includes anabolic steroids, EPO, human growth hormone, and more. Whether doping was or is ubiquitous in the cycling world is not the subject of this blog. It’s the question of whether doctors can prescribe various pharmaceuticals and stay on the right side of the law.

Who has not seen the commercials for “Low T?” Low T is the pharmaceutical companies’campaign addressing low testosterone. Doctors are routinely drawing blood testosterone levels for males in their 50s or 60s complaining of low energy, poor libido, depression, and so forth. If the age adjusted levels of “T” are low, testosterone patch can be prescribed. As long as there is documentation that the age adjusted levels are low, federal law seems to support the ability of doctors to prescribe testosterone to this population. Even if the patient later embarks on a career on the masters cycling circuit once the libido is back in proper working order.

 

What about human growth hormone? Human growth hormone (“HGH”) levels decrease as we age. Some anti-aging clinics prescribe HGH ostensibly to help with “symptoms” of aging. As to whether HGH improves performance in the bed or in the gym remains unknown. What is not in doubt is that some doctors are prescribing it for these purposes.

 

Some physicians hold on to the commonly held belief they are immune from legal repercussions if their patients’ HGH levels remain low. Said another way, these physicians believe they can legally prescribe HGH for anti-aging so long as the patient’s levels are low compared to that of a robust 25 year old. Is this true? HGH is one of the few domains where the FDA has statutory authority over the practice of medicine. We posed the question directly to the FDA.

 

Their answer:

 

Generally, as you know, the Food and Drug Administration does not have authority over health care professionals or the practice of medicine. However, in the case of human growth hormones, we do.

The following section of the Federal Food Drug and Cosmetic Act provides the restrictions and penalties regarding the distribution of HGH:

  • Title 21: Food and Drugs, Chapter 9–Federal Food, Drug, and Cosmetic Act, Subchapter III: Prohibited Acts and Penalties, Sec. 333. Penalties.

Section (e) lists:

(e) Prohibited distribution of human growth hormone

(1) Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute, human growth hormone 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 under section 355 of this title and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, or both.

(2) Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.

(3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes of forfeiture under section 413 of such Act [21 U.S.C. 853].

(4) As used in this subsection the term “human growth hormone” means somatrem, somatropin, or an analogue of either of them.

(5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.

 

Not surprisingly, anti-aging benefits are not considered “the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 355 of this title ….” In other words, while HGH levels do decrease over time, if the levels are typical for someone in his 50’s, a prescription of HGH to a 55 year old might be a problem.

 

But, we could not be sure. So, we probed deeper. If the doctor does little more than write a prescription and it is filled by a pharmacy, is the doctor at legal risk? In other words, is the writing of a prescription considered the “distribution” of HGH?

 

Here is the FDA’s answer provided to us earlier this month:

 

You asked whether a licensed physician writing a prescription for HGH for an unauthorized use, but not actually physically providing the HGH drug to a patient, would be a violation of 21 USC § 333(e).

The agency interprets “distribution” as used in 21 USC § 333(e) to include the writing of a prescription. In addition, all federal criminal statutes, including 21 USC § 333(e), are covered by 18 USC § 2:

“(a) Whoever commits an offense against the United States or aids, abets, counsels, commands, induces or procures its commission, is punishable as a principal.

(b) Whoever willfully causes an act to be done which if directly performed by him or another would be an offense against the United States, is punishable as a principal. ”

I hope that this information is helpful in answering your questions. Please let me know if you have further questions.

Sincerely,

Stephen King

Public Affairs Specialist

Food and Drug Administration

Center for Drug Evaluation and Research

 

So, there you have it.

 

As to whether low age-adjusted levels of HGH would provide a safe harbor, it is hard to say. The penalties for getting it wrong are severe. Caveat prescriber.