{"id":4158,"date":"2022-05-26T08:39:09","date_gmt":"2022-05-26T12:39:09","guid":{"rendered":"https:\/\/a4pc.org\/?p=4158"},"modified":"2022-05-26T12:12:10","modified_gmt":"2022-05-26T16:12:10","slug":"apc-amicus-brief-addresses-ambiguity-in-fda-insanitary-conditions-guidance","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2022-05\/apc-amicus-brief-addresses-ambiguity-in-fda-insanitary-conditions-guidance\/","title":{"rendered":"APC amicus brief addresses ambiguity in FDA insanitary conditions guidance"},"content":{"rendered":"
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Image by Leandro Aguilar from Pixabay.com<\/p><\/div>\n

\u201cInsanitary conditions\u201d are whatever FDA says they are. This is neither legal nor fair.<\/p>\n

That\u2019s the gist of APC\u2019s argument in a \u201cfriend of the court\u201d brief<\/a> filed in U.S. District Court in New Jersey on May 13.<\/p>\n

Funded by member contributions to the APC\u2019s Legal Action Fund, the amicus brief was authorized in response to an urgent request from Wedgewood Pharmacy that APC support its filing for a temporary restraining order against FDA.<\/p>\n

Wedgewood filed its papers seeking a TRO on May 5, 2022, only after FDA demanded that Wedgewood immediately recall all nonsterile products within their expiry period, gave the pharmacy only 24 hours to respond, and failed to provide the pharmacy any information supporting the need for such an extraordinary, broad recall. Wedgewood told the court it suspected that, without the TRO, FDA would move quickly to publish a news release impugning Wedgewood based on FDA\u2019s unsubstantiated findings of \u201cinsanitary conditions\u201d at the pharmacy.<\/p>\n

In the TRO filing, Wedgewood and its lawyers argued that FDA had inspected the pharmacy and issued eight observations in a Form 483 related to vague notions of insanitary conditions, which focused on areas well outside the pharmacy\u2019s compounding areas. Wedgewood further stated that none of the observations listed on the Form 483 FDA violated applicable USP standards.<\/p>\n

APC\u2019s amicus brief, approved by the Executive Committee*, focused solely on the lack of standards in FDA\u2019s Insanitary Conditions GFI and FDA\u2019s failure to promulgate any enforceable rules concerning the same.<\/p>\n

APC engaged in the matter because we were\u2014and remain\u2014concerned about the significant implications on other APC-member compounding pharmacies if FDA continues to impose what appears to be the vague, subjective disciplinary standard suffered by Wedgewood. In particular, FDA derives its enforcement authority from a non-binding guidance document that contains not any objective standards, but instead relies on what appears to be a bunch of examples and the nebulous statement that \u201cother conditions not described in the guidance may also be considered unsanitary.\u201d How is a compounder to know what is in fact violative conduct?<\/p>\n

In that vein, we argue in the amicus that a pharmacy \u201cwould have no basis to know under the plain meaning of the term \u2018insanitary conditions\u2019 or under the explanation set forth in the Insanitary Conditions Guidance that \u2018observed personnel who moved rapidly in a sterile compounding area\u2019 or who \u2018was noted to have their safety glasses down on their nose\u2019 would meet the standard for insanitary conditions.\u201d Both of those were among FDA\u2019s Form 483 observations against Wedgewood.<\/p>\n

Last week the District Court denied Wedgewood\u2019s request for a TRO. The judge said she could not issue a restraining order on an action that had not yet occurred\u2014in this case, FDA\u2019s publishing of a damning press release. But during oral argument, she also made clear that she expected FDA to work with Wedgewood to settle their difference and seemed to suggest she wanted that to occur without FDA publishing a news release that could unnecessarily damage Wedgewood\u2019s reputation based on unsubstantiated or exaggerated claims of \u201cinsanitary conditions.\u201d<\/p>\n

While APC strongly supports the maintenance of sanitary workspaces where compounded drugs are prepared\u2014it\u2019s simply essential for assuring patient safety\u2014there must be standards for what constitute \u201cinsanitary conditions,\u201d and those standards need to be rooted in science and the law. Our amicus brief in this matter is the clearest elucidation of the flaws in FDA\u2019s Insanitary Condition Guidance I\u2019ve seen. I do urge you to read it.<\/p>\n

APC is proud of our involvement in this matter. Just another way we\u2019re looking out for you.<\/p>\n

By the way, if you\u2019d like to fuel our ability to be involved in other legal cases related to pharmacy compounding, please give to APC\u2019s Legal Action Fund<\/a>.<\/p>\n

* Two Wedgewood employees who are members of APC\u2019s Executive Committee recused themselves entirely from the deliberation and voting on the funding request.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

APC engaged in the matter because we were\u2014and remain\u2014concerned about the significant implications on other APC-member compounding pharmacies if FDA continues to impose what appears to be vague, subjective disciplinary standards.
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