Government

Tell the FDA to Reverse Block on Affordable Fertility Treatments

Compounding Pharmacies are no longer able to compound Chroionic Gonadotropin (hCG) and Follicle Stimulating Hormone (FSH), two 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. 

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.

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 substances that were previously pharmaceuticals but are now reclassified as biologics.

Please take action and send letters to the FDA and your Congress representatives and senators to ask them to re-establish access to compounded hCG and FSH.

Tell the FDA to Reverse Block on Affordable Fertility Treatments

Compounding Pharmacies are no longer able to compound Chroionic Gonadotropin (hCG) and Follicle Stimulating Hormone (FSH), two 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. 

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.

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 substances that were previously pharmaceuticals but are now reclassified as biologics.

Please take action and send letters to the FDA and your Congress representatives and senators to ask them to re-establish access to compounded hCG and FSH.