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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="JD-CO" data-source="post: 220307" data-attributes="member: 43706"><p>First post. Thanks for this work that all of you do. You have changed my life and my family’s.</p><p></p><p>It is striking that one of the causes of action was “Whether available evidence of safety and effectiveness supports their use.” In other words, there is no information sufficient to claim there is a public health risk, so prove the negative….does the Act require this criteria during review? Is review even required under the Act?</p><p></p><p>If this NASEM report review was not mandated by the Act, then it might it be worth making a FOIA request to get the intra-agency communications that led up to the inception of the NASEM report (including texts)? From the outside, it appears this report does indeed blur the line on the Act, legislative intent, and the existing jurisprudence. And to the benefit of massively resourced companies that can meet the FDA requirements, at the expense of public (my) health. This may further undermine the report if a specific big-Pharma tie can be made. And may aid in follow on litigation…preserve the record…</p><p></p><p>Who are the attorneys fighting against this? Non-profit or have the compounding pharmacies taken a stand collectively? I mean, their market could be annihilated….</p></blockquote><p></p>
[QUOTE="JD-CO, post: 220307, member: 43706"] First post. Thanks for this work that all of you do. You have changed my life and my family’s. It is striking that one of the causes of action was “Whether available evidence of safety and effectiveness supports their use.” In other words, there is no information sufficient to claim there is a public health risk, so prove the negative….does the Act require this criteria during review? Is review even required under the Act? If this NASEM report review was not mandated by the Act, then it might it be worth making a FOIA request to get the intra-agency communications that led up to the inception of the NASEM report (including texts)? From the outside, it appears this report does indeed blur the line on the Act, legislative intent, and the existing jurisprudence. And to the benefit of massively resourced companies that can meet the FDA requirements, at the expense of public (my) health. This may further undermine the report if a specific big-Pharma tie can be made. And may aid in follow on litigation…preserve the record… Who are the attorneys fighting against this? Non-profit or have the compounding pharmacies taken a stand collectively? I mean, their market could be annihilated…. [/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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