Letter to FDA: Schrader, Yoho have questions about draft GFI #256
PLUS: Hints that FDA will extend the comment period
In a joint letter to FDA this week,
Congressmen Kurt Scrader (OR) and Ted Yoho (FL) posed questions to FDA about the agency's statutory authority to issue draft GFI #256 related to animal compounding:
"GFI #256 is very similar to GFI #230, which was released in April of2015 and rescinded in 2017. In the final appropriations bills for FY2017 and FY2018, Congress included report language expressing concerns that the previous guidance on animal drug compounding, GFI #230, exceeded FDA's statutory authority. Given these concerns and others, we seek clarification on the new draft guidance and ask that FDA extend the public comment period by 90 days to allow for sufficient stakeholder input.
The letter also questions the scientific basis for the requirement in the draft GFI that animal drugs be compounded almost exclusively from FDA-approved manufactured drugs.
The congressmen's interest in the issue is the result of work by APC and its partners to bring concerns about the draft GFI to the attention of members of Congress.
"In coming days, we'll also be collaborating with Wedgewood Pharmacy, PCCA and others to develop a congressional sign-on letter expressing concern about the draft GFI," said APC chief executive officer Scott Brunner, CAE.
Also this week, the American Pharmacist Association and National Community Pharmacists Association joined with APC in asking FDA to extend the comment period on the draft GFI on animal drug compounding.
Read that joint letter here. The American Veterinary Medical Association also wrote to FDA this week requesting an extension. On Thursday, an FDA employee indicated in an email that the extension would be confirmed soon.
"Our clear sense is that FDA will be granting an extension, which will allow for more stakeholder evaluation and input on GFI #256," said Brunner.
APC issued a call-to-action on the GFI this week, asking compounders to offer comments to FDA via a template letter available on APC's grassroots platform. See the link to that letter below.
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