Compounding Pharmacies are no longer able to compound Chorionic Gonadotropin (hCG), Follicle Stimulating Hormone (FSH),and HMG, three hormones that have been produced for over 50 years safely and more affordably by the compounding industry. This creates significant access issues for hypogonadal and fertility patients who have relied on this access for the last 5 decades.
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This access issue has been brewing for a few years. Under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) – Protein-based drug products like hCG and FSH that had previously been approved as “Drugs” are now be considered Biologics and fall under the jurisdiction of the FDA’s Center for Biologics Evaluation and Research (CBER). This law was not established to limit access, but to expand access and lower pricing. However, this change accomplished the opposite: Difficult access and high prices.
Brief Background:
Congress had previously passed the Drug Quality Security Act (DQSA) to regulate the compounding industry, and gave an exemption for compounders not to have to file and hold a New Drug Application (NDA) for products like hCG and FSH that were filed as “drugs” under DQSA under section 505. However, under the BPCIA, Biologics must now be approved and licensed (with a Biologics License Application -BLA) under section 351. In order to lawfully enter a Biologic product into US commercial distribution, even if the product is an old generic like hCG or FSH that was previously exempted, the seller must hold a BLA for that product. Developing a BLA is a costly and long process that is required for new research products that are considered for FDA approval. Having old products like hCG and FSH be required to go through this new process is counterproductive and presents barriers to access to patients who have been using these products for years to improve their quality of life and their chances to start a family.
Compounders have been compounding urine-derived hCG, FSH, and hMG and increasing patient access to these medications for nearly 50 years. For example, hCG and FSH will still be the same drugs that they were in 1973 and 1983 when they were approved by the FDA. Patients should not suffer due to access issues as a result of a purely regulatory change.
We are requesting that the FDA allows an exception for compounding pharmacies to continue to produce “transitional biologics”. Transitional biologics include old substances that were previously pharmaceuticals drugs but are now reclassified as biologics.
For more details on this issue, visit: Access to Compounded hCG, FSH and hMG Is Now Blocked Due to FDA Law