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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Group Tells the FDA to Restrict the Use of Compounded Hormones
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<blockquote data-quote="Nelson Vergel" data-source="post: 191992" data-attributes="member: 3"><p>[URL unfurl="true"]https://a4pc.org/APC/Advocacy/Federal-advocacy/NASEM-cBHT.aspx[/URL]</p><p></p><p>[URL unfurl="true"]https://www.savemycompounds.com/[/URL]</p><p></p><p>The FDA, no fan of compounding, commissioned a study from the National Academies of Sciences, Engineering, and Medicine on "the safety, effectiveness, and use" of compounded bioidentical hormone [replacement] therapy (cBHT or cBHRT). The study concluded that there isn't much clinical evidence for or against cBHT. Strangely, though, the study recommended that cBHT be restricted.</p><p></p><p>Now, despite the undisputed fact that millions of Americans use cBHT every day and rely on it, the FDA is using that study — yes, the one it paid for — as an excuse to consider limiting or even outright banning compounded hormone therapy.</p><p></p><p>This cannot be allowed to happen. The lives and health of too many people are at risk.</p><p></p><p><strong>Have you benefited from Compounded Bioidentical Hormone Replacement Therapy (cBHRT)? If so, you won't be happy with what the FDA is planning.</strong></p><p></p><p>The FDA has never been a fan of pharmacy compounding, but now it is making a move that could keep millions of people from using this critical therapy.</p><p></p><p>Here's the deal:</p><p></p><p>Last year, the agency commissioned the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a study of cBHRT. The study ignored vast amounts of clinical evidence of its current effective use. But not surprising, NASEM recommended that cBHRT be severely restricted—which is exactly what the FDA paid it to say. The NASEM committee was composed of medical professionals with sterling credentials. However, <strong>none of the committee members has any clinical expertise or experience treating women or men with compounded hormones, and no experts on compounding were on the committee!</strong></p><p></p><p>Never mind that tens of thousands of providers prescribe, and millions of Americans use cBHRT every day and rely on it. Never mind that the study didn't find any significant negative effects of cBHRT. Oh, and never mind that the NASEM study didn't even ask the basic question: Does cBHRT work for patients? (It does. Very well.)</p><p></p><p>And now:</p><p></p><p>The FDA is using that study—yes, the one it paid for—as an excuse to consider limiting compounded hormone therapy by adding the entire class of medication to its so-called “too-difficult-to-compound list. Under federal law, FDA does have the authority to place individual medications but not entire classes of drugs to this list. And there must be clear evidence of safety issues.</p><p></p><p>You read that right: <strong>If you use cBHRT, the medication may no longer be available to you.</strong></p><p></p><p>In November 2020, 32 members of the House of Representatives sent a letter to the FDA commissioner, asking that the agency not limit cBHRT. That letter had a big impact but it’s not too late for individual members of Congress to add their voices to the chorus asking FDA to take action to protect <strong>hormone therapy.</strong></p><p></p><p>We’ve made it easy for you. If you have not participated in one of these campaigns before, just enter your name and address in the box to the right. (If you have participated before, your information has already been entered for you.) We’ll match you with your House representative and Senators and provide pre-written messages that you can customize. (If your Representative is a sponsor of the letter, you’ll be thanking him or her for doing so!)</p><p></p><p>[URL unfurl="true"]https://www.savemycompounds.com/take-action/?vvsrc=%2fcampaigns%2f77723%2frespond[/URL]</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 191992, member: 3"] [URL unfurl="true"]https://a4pc.org/APC/Advocacy/Federal-advocacy/NASEM-cBHT.aspx[/URL] [URL unfurl="true"]https://www.savemycompounds.com/[/URL] The FDA, no fan of compounding, commissioned a study from the National Academies of Sciences, Engineering, and Medicine on "the safety, effectiveness, and use" of compounded bioidentical hormone [replacement] therapy (cBHT or cBHRT). The study concluded that there isn't much clinical evidence for or against cBHT. Strangely, though, the study recommended that cBHT be restricted. Now, despite the undisputed fact that millions of Americans use cBHT every day and rely on it, the FDA is using that study — yes, the one it paid for — as an excuse to consider limiting or even outright banning compounded hormone therapy. This cannot be allowed to happen. The lives and health of too many people are at risk. [B]Have you benefited from Compounded Bioidentical Hormone Replacement Therapy (cBHRT)? If so, you won't be happy with what the FDA is planning.[/B] The FDA has never been a fan of pharmacy compounding, but now it is making a move that could keep millions of people from using this critical therapy. Here's the deal: Last year, the agency commissioned the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a study of cBHRT. The study ignored vast amounts of clinical evidence of its current effective use. But not surprising, NASEM recommended that cBHRT be severely restricted—which is exactly what the FDA paid it to say. The NASEM committee was composed of medical professionals with sterling credentials. However, [B]none of the committee members has any clinical expertise or experience treating women or men with compounded hormones, and no experts on compounding were on the committee![/B] Never mind that tens of thousands of providers prescribe, and millions of Americans use cBHRT every day and rely on it. Never mind that the study didn't find any significant negative effects of cBHRT. Oh, and never mind that the NASEM study didn't even ask the basic question: Does cBHRT work for patients? (It does. Very well.) And now: The FDA is using that study—yes, the one it paid for—as an excuse to consider limiting compounded hormone therapy by adding the entire class of medication to its so-called “too-difficult-to-compound list. Under federal law, FDA does have the authority to place individual medications but not entire classes of drugs to this list. And there must be clear evidence of safety issues. You read that right: [B]If you use cBHRT, the medication may no longer be available to you.[/B] In November 2020, 32 members of the House of Representatives sent a letter to the FDA commissioner, asking that the agency not limit cBHRT. That letter had a big impact but it’s not too late for individual members of Congress to add their voices to the chorus asking FDA to take action to protect [B]hormone therapy.[/B] We’ve made it easy for you. If you have not participated in one of these campaigns before, just enter your name and address in the box to the right. (If you have participated before, your information has already been entered for you.) We’ll match you with your House representative and Senators and provide pre-written messages that you can customize. (If your Representative is a sponsor of the letter, you’ll be thanking him or her for doing so!) [URL unfurl="true"]https://www.savemycompounds.com/take-action/?vvsrc=%2fcampaigns%2f77723%2frespond[/URL] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Group Tells the FDA to Restrict the Use of Compounded Hormones
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