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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Your Access to More Economical hCG and FSH Ended in November 2021
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<blockquote data-quote="Nelson Vergel" data-source="post: 172209" data-attributes="member: 3"><p>These were the public comments received by the FDA (over 400 comments)</p><p></p><p>[URL unfurl="true"]https://www.regulations.gov/document/FDA-2015-D-4750-0021/comment[/URL]</p><p></p><p>Here is mine:</p><p></p><p>Dear FDA Representatives:</p><p></p><p>I am a consumer and advocate that comes to you with great concern about my and my community's access to fertility biologics such as hCG and FSH. I represent over 38,000 men and women who have joined my educational sites ExcelMale.com and Facebook's Women's Health and HRT groups. I am also a long-term HIV survivor, activist, and author of four health books that educate consumers to increase their self-advocacy and health literacy about hormone treatment access.</p><p></p><p>As you are well aware, under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) - Protein-based drug products like hCG, FSH, and hMG that had previously been approved as "drugs" will now be considered Biologics and will fall under the jurisdiction of the FDA's Center for Biologics Evaluation and Research (CBER). The Drug Quality Security Act (DQSA), previously gave an exemption for not having the need to file and hold a New Drug Application (NDA) for "drugs" that were filed as drugs under DQSA under section 505. Biologics must now be approved and licensed (with a Biologics License Application -BLA) under section 351. DQSA gives no exemptions under section 351. In order to lawfully enter a Biologic product into US commercial distribution, even if the product is an old generic hCG, hMG or FSH that was previously exempted, the seller must hold a BLA for that product. By the plain letter of the statutory law, this would preclude all compounding or production by 503B or 503A without a BLA. Developing a BLA is a costly and long process that is required for new research products that are considered for FDA approval. Having old urinary based gonadotropins be required to go through this process as a new biologic 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 procreate.</p><p></p><p>Compounders have been compounding urine-derived hCG, FSH, and hMG and increasing patient access to these medications for nearly 50 years. Specifically, Outsourcing Facilities have supplied HCG and Hyaluronidase so that clinicians may treat patients and come March 23, 2020 nothing in these drugs will change. For example, hCG will still be the same drug that it was in 1973 when it was approved by the FDA. It is my belief that patients should not suffer due to access issues as a result of a purely regulatory change. If FDA does not clarify that these old medications will be regulated as "drugs" for purposes of Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act, significant disruptions to patient access and patient care may arise.</p><p></p><p>FDA can offer enforcement discretion to allow the continued compounding of certain transition biologics like Insulin, hCG, FSH, and hMG. However, at this time FDA has not offered any information regarding their enforcement intentions. The due date is fast approaching and the community just found out about this potential access disruption issue.</p><p></p><p>To protect patient access to these medications and resolved the current confusion, I request that the FDA immediately clarify that approved NDAs for biological products that have been compounded for many years continue to be regulated as "drugs" for purposes of compounding pursuant to Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic ("FD&C") Act. This includes but is not limited to the following products: insulin, human chorionic gonadotropin (HCG), follicle-stimulating hormone (FSH), and human menopausal hormone (hMG).</p><p></p><p>I have written a brief background of what issues surrounding access to affordable hCG, FSH (and HMG) are in the following section.</p><p></p><p>Thank you so much for your consideration in this matter.</p><p></p><p>In health,</p><p></p><p>Nelson Vergel</p><p>Consumer and Advocate</p><p></p><p>File attached</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 172209, member: 3"] These were the public comments received by the FDA (over 400 comments) [URL unfurl="true"]https://www.regulations.gov/document/FDA-2015-D-4750-0021/comment[/URL] Here is mine: Dear FDA Representatives: I am a consumer and advocate that comes to you with great concern about my and my community's access to fertility biologics such as hCG and FSH. I represent over 38,000 men and women who have joined my educational sites ExcelMale.com and Facebook's Women's Health and HRT groups. I am also a long-term HIV survivor, activist, and author of four health books that educate consumers to increase their self-advocacy and health literacy about hormone treatment access. As you are well aware, under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) - Protein-based drug products like hCG, FSH, and hMG that had previously been approved as "drugs" will now be considered Biologics and will fall under the jurisdiction of the FDA's Center for Biologics Evaluation and Research (CBER). The Drug Quality Security Act (DQSA), previously gave an exemption for not having the need to file and hold a New Drug Application (NDA) for "drugs" that were filed as drugs under DQSA under section 505. Biologics must now be approved and licensed (with a Biologics License Application -BLA) under section 351. DQSA gives no exemptions under section 351. In order to lawfully enter a Biologic product into US commercial distribution, even if the product is an old generic hCG, hMG or FSH that was previously exempted, the seller must hold a BLA for that product. By the plain letter of the statutory law, this would preclude all compounding or production by 503B or 503A without a BLA. Developing a BLA is a costly and long process that is required for new research products that are considered for FDA approval. Having old urinary based gonadotropins be required to go through this process as a new biologic 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 procreate. Compounders have been compounding urine-derived hCG, FSH, and hMG and increasing patient access to these medications for nearly 50 years. Specifically, Outsourcing Facilities have supplied HCG and Hyaluronidase so that clinicians may treat patients and come March 23, 2020 nothing in these drugs will change. For example, hCG will still be the same drug that it was in 1973 when it was approved by the FDA. It is my belief that patients should not suffer due to access issues as a result of a purely regulatory change. If FDA does not clarify that these old medications will be regulated as "drugs" for purposes of Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act, significant disruptions to patient access and patient care may arise. FDA can offer enforcement discretion to allow the continued compounding of certain transition biologics like Insulin, hCG, FSH, and hMG. However, at this time FDA has not offered any information regarding their enforcement intentions. The due date is fast approaching and the community just found out about this potential access disruption issue. To protect patient access to these medications and resolved the current confusion, I request that the FDA immediately clarify that approved NDAs for biological products that have been compounded for many years continue to be regulated as "drugs" for purposes of compounding pursuant to Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic ("FD&C") Act. This includes but is not limited to the following products: insulin, human chorionic gonadotropin (HCG), follicle-stimulating hormone (FSH), and human menopausal hormone (hMG). I have written a brief background of what issues surrounding access to affordable hCG, FSH (and HMG) are in the following section. Thank you so much for your consideration in this matter. In health, Nelson Vergel Consumer and Advocate File attached [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Your Access to More Economical hCG and FSH Ended in November 2021
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