FDA drug action on hold

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Last week the Food and Drug Administration (FDA) withdrew two 1977 notices of opportunity for a hearing (NOOH) which proposed to withdraw certain approved uses of penicillin and tetracyclines intended for use in feeds for food-producing animals based in part on microbial food safety concerns.

Search the Internet and you can find all of the anti-ag or anti-antibiotic media having a heyday with sounding the alarm of how devastating this will be for public health. I found it interesting that this article in the Huffington Post had as its first person to quote a staff attorney for the Natural Resources Defense Council.

This doesn’t mean a free-for-all in terms of indiscriminate use of any food-animal antibiotics despite what consumer media might make it sound like. Veterinarians and their producers are still under strict guidelines for antibiotic use in food animals.

This also doesn’t mean that this won’t be revisited in the future. The FDA summary (below) says, “Today's action should not be interpreted as a sign that FDA no longer has safety concerns about the use of medically important antibiotics in food producing animals or that FDA will not consider re-proposing withdrawal proceedings in the future, if necessary. FDA has not ruled out the prospect of future regulatory action…”

FDA summary
At this time, FDA is withdrawing the 1977 NOOHs because: (1) FDA is engaging in other ongoing regulatory strategies developed since the  publication of the 1977 NOOHs with respect to addressing microbial food  safety issues; (2) FDA would update the NOOHs to reflect current data,  information, and policies if, in the future, it decides to move forward with withdrawal of the approved uses of the new animal drugs described in the NOOHs; and (3) FDA would need to prioritize any withdrawal proceedings (for example, take into account which withdrawal(s) would likely have the most significant impact on the public health) if, in the future, it decides to seek withdrawal of the approved uses of any new animal drug or class of drugs.

Although FDA is withdrawing the 1977 NOOHs, FDA continues to view antimicrobial resistance as a significant public health issue. Today's action should not be interpreted as a sign that FDA no longer has safety concerns about the use of medically important antibiotics in food producing animals or that FDA will not consider re-proposing withdrawal proceedings in the future, if necessary. FDA has not ruled out the prospect of future regulatory action, either with respect to the antimicrobial new animal drugs covered by the 1977 NOOHs or any others. However, for now, FDA's efforts will focus on promoting voluntary reform and the judicious use of antimicrobials in the interest of best using the agency's overall resources to protect the public health. Importantly, this strategy leaves open the possibility of pursuing withdrawal proceedings at a later time if FDA's proposed strategy does not yield satisfactory results.

As indicated previously, as part of the withdrawal of the two 1977 NOOHs, the Agency will close their corresponding dockets. However, we encourage interested persons to submit comments to the docket established in connection with draft GFI 209. The docket number associated with draft GFI 209 is FDA-2010-D-0094.

Read the full FDA report here.



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