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Feedback & Shout Outs to Moderators
Senators ask Biden administration to loosen restrictions on testosterone access
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<blockquote data-quote="Nelson Vergel" data-source="post: 234003" data-attributes="member: 3"><p>There will be strong Republican opposition even if it means better access for ALL even if trans people are the main focus.</p><p></p><p>Someone drafted a letter in May to protect the <a href="https://www.excelmale.com/forum/threads/please-tell-the-fda-and-congress-to-protect-and-allow-access-to-compounded-hormones.24507/" target="_blank">11 hormones the FDA wants to ban compounders from making</a>. In activism, you use the lowest hanging fruit that may benefit ALL even if a small population is the focus.</p><p></p><p>Robert M. Califf M.D.</p><p></p><p>Commissioner</p><p></p><p>Food and Drug Administration</p><p></p><p>10903 New Hampshire Avenue</p><p></p><p>Silver Spring, MD 20993</p><p></p><p></p><p></p><p></p><p></p><p>Dear Acting Administrator Woodcock:</p><p></p><p></p><p></p><p>We are writing to express our concern with recommendations made to the Food and Drug Administration (FDA) by an Ad Hoc Committee of the<a href="https://www.excelmale.com/forum/threads/call-to-action-stop-the-fda-from-restricting-compounded-hormone-therapy.21918/" target="_blank"> National Academy of Science, Engineering and Medicine (NASEM)</a> which may have a negative impact on transgender community’s equal access to health care. The NASEM recommendations, which stem from a study commissioned during the previous Administration, include a proposal that would effectively outlaw the use of compounded bioidentical hormones (cBHT) for transgender individuals. These medications are vital to transgender individuals undergoing hormonal treatment to affirm their gender identity.</p><p></p><p></p><p></p><p>The use of cBHT has increased in recent times for transgender patients. Compounded hormones greatly increase the treatment options available for this underserved population and provide access to necessary care that might otherwise be denied. Medical providers work closely with patients and customize compounded hormone preparations to meet their individual and personalized needs.</p><p></p><p></p><p></p><p>The NASEM Committee’s report recommended that most cBHTs be nominated and considered for inclusion on FDA’s “too difficult to compound” list which would effectively outlaw these essential treatments. According to the NASEM report, cBHTs are currently used nationwide by millions of patients, which would make this proposal disruptive for those patients’ current medical treatments.</p><p></p><p></p><p></p><p>Inclusion on the “too difficult to compound list” would also create unnecessary barriers to health care for a community that is already underserved in our health system. According to the National Center for Transgender Equality’s US Trans Survey in 2015, more than three-quarters of transgender and non-binary people wanted hormone therapy related to gender transition, yet only 49 percent had ever received it. To follow these recommendations would only create more hurdles for transgender people and exacerbate these rates.</p><p></p><p></p><p></p><p>Further, the NASEM Committee, which developed these recommendations, did not include committee members with practical experience in compounded hormone therapy for either women with hormonal imbalance or transgender patients seeking treatment with cBHTs.</p><p></p><p></p><p></p><p>We encourage the FDA to reject the recommendation that cBHTs be considered for inclusion on the “too difficult to compound” list. We also ask that any further discussion or examination of this issue be conducted in a process that includes the active participation of members of the transgender community and experienced providers with the practical knowledge of the benefits of compounded hormone therapy.</p><p></p><p></p><p></p><p>Thank you in advance for your consideration of this request.</p><p></p><p></p><p></p><p>Sincerely,</p><p></p><p></p><p></p><p></p><p>Members of Congress</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 234003, member: 3"] There will be strong Republican opposition even if it means better access for ALL even if trans people are the main focus. Someone drafted a letter in May to protect the [URL='https://www.excelmale.com/forum/threads/please-tell-the-fda-and-congress-to-protect-and-allow-access-to-compounded-hormones.24507/']11 hormones the FDA wants to ban compounders from making[/URL]. In activism, you use the lowest hanging fruit that may benefit ALL even if a small population is the focus. Robert M. Califf M.D. Commissioner Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Dear Acting Administrator Woodcock: We are writing to express our concern with recommendations made to the Food and Drug Administration (FDA) by an Ad Hoc Committee of the[URL='https://www.excelmale.com/forum/threads/call-to-action-stop-the-fda-from-restricting-compounded-hormone-therapy.21918/'] National Academy of Science, Engineering and Medicine (NASEM)[/URL] which may have a negative impact on transgender community’s equal access to health care. The NASEM recommendations, which stem from a study commissioned during the previous Administration, include a proposal that would effectively outlaw the use of compounded bioidentical hormones (cBHT) for transgender individuals. These medications are vital to transgender individuals undergoing hormonal treatment to affirm their gender identity. The use of cBHT has increased in recent times for transgender patients. Compounded hormones greatly increase the treatment options available for this underserved population and provide access to necessary care that might otherwise be denied. Medical providers work closely with patients and customize compounded hormone preparations to meet their individual and personalized needs. The NASEM Committee’s report recommended that most cBHTs be nominated and considered for inclusion on FDA’s “too difficult to compound” list which would effectively outlaw these essential treatments. According to the NASEM report, cBHTs are currently used nationwide by millions of patients, which would make this proposal disruptive for those patients’ current medical treatments. Inclusion on the “too difficult to compound list” would also create unnecessary barriers to health care for a community that is already underserved in our health system. According to the National Center for Transgender Equality’s US Trans Survey in 2015, more than three-quarters of transgender and non-binary people wanted hormone therapy related to gender transition, yet only 49 percent had ever received it. To follow these recommendations would only create more hurdles for transgender people and exacerbate these rates. Further, the NASEM Committee, which developed these recommendations, did not include committee members with practical experience in compounded hormone therapy for either women with hormonal imbalance or transgender patients seeking treatment with cBHTs. We encourage the FDA to reject the recommendation that cBHTs be considered for inclusion on the “too difficult to compound” list. We also ask that any further discussion or examination of this issue be conducted in a process that includes the active participation of members of the transgender community and experienced providers with the practical knowledge of the benefits of compounded hormone therapy. Thank you in advance for your consideration of this request. Sincerely, Members of Congress [/QUOTE]
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Feedback & Shout Outs to Moderators
Senators ask Biden administration to loosen restrictions on testosterone access
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