How a regulatory change could impact HCG availability.
What is HCG?
HCG (Human Chorionic Gonadotropin) is a hormone found in the urine of pregnant women. HCG is FDA-approved for the treatment of select cases of female infertility and hormone treatment in men. FDA-approved HCG products are only available in injection-form and require a prescription from a licensed medical professional.
HCG & Weight Loss
In the 1950s a British endocrinologist named Albert Simeons was investigating HCG as a treatment for Frohlich’s syndrome, a delayed development of the genitals in adolescent boys caused by a pituitary gland disorder. During his trials he noted that boys treated with HCG had lost weight and had less appetite. This lead to Dr. Simeons turning his research to HCG for weight loss and he created a diet plan that includes the use of HCG in combination with a very low calorie (500 calories per day) diet.
While Dr. Simeons was able to generate interesting results using his protocol, other researchers have failed to replicate them. A meta-analysis that included more than 20 different studies of HCG found that “there is no scientific evidence that HCG is effective in the treatment of obesity; it does not bring about weight-loss of fat-redistribution, nor does it reduce hunger or induce a feeling of well-being” (Lijesen et al, 1995).
It is important to note that HCG has never been approved for use in weight loss. “Currently, there are no FDA-approved HCG drug products for weight loss. HCG has not been demonstrated to be effective therapy in the treatment of obesity. There is no substantial evidence that HCG increases weight loss” (FDA, 2016).
Regulatory Changes
The FDA is planning to re-categorize a number of approved drugs, including HCG, as “biological products”. This change is to take effect on March 23, 2020 and is expected to impact the availability of HCG in 2020 and beyond.
“On March 23, 2020, an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) shall be deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (see section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009)” (FDA, 2019).
What This Means
To produce a drug product, a manufacturer must submit an application for a new drug approval even if it is an existing drug already on the market. FDA regulations provide exceptions that allow registered 503B compounding pharmacies to produce certain drugs without one of these approvals. These exceptions do not exist for biological products.
As a part of the transition, FDA is converting drug approvals for the impacted products to biological approvals. Because HCG currently does not require a drug approval to be produced by compounding pharmacies, they do not hold such approvals and therefore will not be licensed to produce HCG as of the March 23, 2020 deadline. At the time of this writing, only 3 pharmaceutical companies will be licensed to produce HCG, and it is possible that not all of them will take advantage of that ability.
This means that HCG will be harder to find, and will likely increase in price.
References:
Schwarcz, J. (2017). The Skinny on the HCG Weight Loss Scheme. McGill University.
Lijesen, G. K., Theeuwen, I., Assendelft, W. J., & Van Der Wal, G. (1995). The effect of human chorionic gonadotropin (HCG) in the treatment of obesity by means of the Simeons therapy: a criteria-based meta-analysis. British journal of clinical pharmacology, 40(3), 237–243. https://doi.org/10.1111/j.1365-2125.1995.tb05779. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1365103/
FDA. (2016). Questions and Answers on HCG Products for Weight Loss. Retrieved from: https://www.fda.gov/drugs/medication-health-fraud/questions-and-answers-hcg-products-weight-loss
FDA. (2019). Preliminary List of Approved NDAs for Biological Products. Retrieved from: https://www.fda.gov/media/119229/download
