Access to care: are hcg and fsh available from fda-approved pharmacies for men with hypogonadism and infertility?

Abstract Introduction Male hypogonadism-induced infertility has a varied etiology and no standard therapy exists for treatment. Human chorionic gonadotropin (hCG) is an FDA-approved medication indicated for hypogonadal men seeking to promote fertility, in addition to off-label therapies such as selective estrogen receptor modulators (i.e. clomiphene citrate, follicle stimulating hormone (FSH), and aromatase inhibitors). Human biologics, such as hCG and FSH, have been compounded in the United States by licensed medical professionals and outsourcing pharmacies under the Federal Food, Drug, and Cosmetic Act (FDA) sections 503A and 503B, respectively. In March of 2020, changes in these laws greatly restricted the ability for 503A and 503B compounders to produce various human biological agents, including hCG and FSH. These legislative measures, in addition to global supply chain deficiencies, have created challenges for hypogonadal men seeking fertility. To better understand barriers to accessing hCG and FSH for infertility, we performed a study to survey all FDA-registered 503b compounding pharmacies. Objective To determine the number of FDA-approved 503B compounding pharmacies who are currently supplying hCG and FSH for the treatment of male hypogonadism and infertility. Secondary objectives include exploring reasons underlying the interruption or discontinuation of these agents. Methods A review of the FDA-approved 503B compounding pharmacies was performed using the online published registry available from the FDA. Each pharmacy was contacted regarding their ability to provide hCG and FSH therapy. Additional questions discussing the impact of FDA-related law changes, supply chain interruptions, and cost considerations were also explored. Results The seventy-six 503B compounding pharmacies approved by the FDA to produce hCG and FSH therapy were identified using the FDA registry. Sixty-six of the seventy-six pharmacies were contacted and responded to the survey (response rate = 86.8%). Of the approved pharmacies, five provided hCG (6.58%). Of the pharmacies offering compounded hCG, four offered FSH. No additional pharmacies offered compounded FSH. Eight pharmacies previously provided hCG and FSH (10.53%). Six of the eight pharmacies who stopped making hCG and FSH cited the 2020 FDA mandate as the reason for halting compounding services. Out of the 66 pharmacies who responded, only one pharmacy was able to provide the cost for FSH ($287) and three pharmacies were able to provide the cost for hCG ($50-83 per 10,000 IU vial). Conclusions Biologics, such as hCG and FSH, have been demonstrated to provide therapeutic benefit in hypogonadal men seeking treatment while maintaining fertility. However, there is limited access to FDA-approved compounded therapies for male infertility. This results in a large population of patients who are left underserved, and are subsequently subjected to high-cost alternatives, non-FDA approved compounding pharmacies, or a complete lack of therapy. These results demonstrate the important need to reduce the barriers to hCG and FSH access, and improve the treatment options for this vulnerable patient population. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Pharmaceuticals