1. #1
    Super Moderator Nelson Vergel's Avatar
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    Defend Your Access to Compounding Products: Send the FDA your comments

    Background information:
    FDA compounding enforcement draws ire from Congress

    The FDA is asking for comments now (Deadline July 18)

    Please add your comments to defend the compounding industry before the FDA imposes more restrictions. They are requesting comments now.

    https://www.regulations.gov/searchRe...p=true&ns=true



    I posted this comment on the 4 guidances (I focused on my HIV work since it is probably more effective to do so, but you guys should add your personal experiences in TRT, etc. You can cut and paste some of this content if you wish) :

    "The FDA needs community representation when drafting guidances related to compounding pharmacies since patient's options will be decreased by the extra requirements on 503A and 503B facilities.

    The exorbitant pharma prices are causing public backlash. So efforts should be focused on expanding access to affordable compounding medications, NOT on limiting it.

    I would like to thank the FDA for their efforts to keep us safe but feel compelled to stress that this effort cannot be so extreme that our options as patients are limited.

    The FDA has a really bad reputation among patients who think that this taxpayer funded government agency is being manipulated by big pharma. This is probably unfair but increasing extreme requirements on compounding will only enhance that negative branding.

    A recent report from a House committee reminded the FDA that "compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated healthcare providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states". Imposing regulations similar to ones imposed on big pharma represents an unnecessary extra burden on compounding pharmacies as small businesses.

    Without access to low cost compounded products, I and many of my non-profit organization's constituents would have died of HIV wasting and other conditions. We find ourselves needing medications that insurance companies refuse to cover due to their shrinking formularies, so low cost compounded products have filled an important role in our quality of life and survival.

    Please carefully review the need for extra burden imposed on these small businesses that have been affected by a few bad companies that did not follow sterility guidelines that are already in place."

    Letter from members of Congress to the FDA: https://c.ymcdn.com/sites/iacp.site-...fice_Use_L.pdf
    Last edited by Nelson Vergel; 07-12-2016 at 06:26 PM.

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    Should we post comments on all of the open categories? Is it ok to post the same comment on each category?

    This is, essentially, what I posted in each area open for comments:

    "Thank you for your efforts to keep us safe but please take care to not regulate compounding pharmacies so heavily that our options as patients are limited.


    The FDA has developed a negative reputation among patients (whether justified or not) because many patients think that this taxpayer funded government agency is being manipulated by the largest corporations in the pharmaceutical industry. Compounding pharmacies are a life saver to many of us patients who cannot get our medications through our insurance plans and punitive restrictions on compounding will only enhance the negative branding that the FDA is already feeling.


    New laws, rules, and regulations always have unintended consequences. I believe that the FDA must seek community representation when drafting guidances related to compounding pharmacies since patient's options will be decreased by the extra requirements on 503A and 503B facilities. As a representative of taxpaying citizens, the FDA's efforts should be focused on expanding access to affordable compounding medications, NOT on limiting it.


    This House committee report (http://appropriations.house.gov/uplo...griculture.pdf) should remind you that "compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated healthcare providers that are inspected by state boards of pharmacy pursuant to state laws and regulations that establish sterility and other standards for the pharmacies operating within their states". Imposing regulations similar to ones imposed on big pharma represents an unnecessary extra burden on compounding pharmacies as small businesses.


    Having run a small business, it seems to me that we do not need more regulations or tighter hoops to jump through, rather, we need better enforcement of the current rules. Please carefully review the need for extra burden imposed on these small businesses that have been affected by a few bad companies that did not follow sterility guidelines that are already in place.
    Last edited by Steve Williams; 07-11-2016 at 12:41 PM. Reason: added a copy of my comments.

  4. #3
    Quote Originally Posted by Nelson Vergel View Post
    The FDA has a really bad reputation among patients who think that this taxpayer funded government agency is being manipulated by big pharma. This is probably unfair but increasing extreme requirements on compounding will only enhance that negative branding.
    This is so true.
    Thanks nelson for letting us know I guessed and posted under Drug Industry - C0022

  5. #4
    Super Moderator Nelson Vergel's Avatar
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    From my great friend Lee Myers:


    Congress Fights for Compounding Pharmacies Against the FDA and Big Pharma

    According to a recent Peak Testosterone Forum poll, about 70% of our men on TRT (testosterone therapy) are using either compounded injectible testosterone or compounded HCG. I know that we have a couple of guys using compounded creams as well. And the percentage of women using compounded hormonal creams would likely be even higher still. Basically, compounded products offer incredible value and customization for those on TRT or HRT and they in HOT demand. There are competing brand name Big Pharma products, but they are ridiculously expensive and, in the case of women's hormones, are nasty synthetics that almost no one wants.

    As expected, Big Pharma, working through the FDA, has come after the compounding pharmacies with a vengeance in the last couple of years and are doing all they can to crush the compounding industry into oblivion, or at best abject servitude.

    The latest strongarming comes from the following set of FDA regulations and letters: http://www.peaktestosterone.com/Cong...acies_FDA.aspx

  6. #5

  7. #6
    I'd like to know how much BIG PHARMA had spent on lobbyist/bribery on this
    I'm really happy with empower and I hope things go well for them and other compounding pharmacies. If things don't go well it will undoubtedly lead some to unsafe/illegal black market options.

  8. #7

  9. #8
    Yes the FDA is in the pockets of pharma...

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