FDA Schedules Hearing on Mecadox
The Food and Drug Administration (FDA) provided notice in the Federal Register on Tuesday of its intention to hold a public hearing regarding Mecadox (carbadox) on March 10.
Mecadox has been approved and sold in the United States for 50 years as a widely used treatment for controlling bacterial diseases in swine, including Salmonella and swine dysentery, resulting in improved health and welfare for newly born and young pigs.
The hearing, hosted by the FDA, seeks data and information related to the safety of the product, according to a release.
The FDA issued a Notice of Opportunity for Hearing (NOOH) in 2016 setting in motion the initial steps in a process to rescind its approval of carbadox based on concerns about the potential persistence of carcinogenic residues, the release said. The FDA formally withdrew the NOOH in 2020 and instead issued a Proposed Order to rescind approval for the “regulatory method” that is part of carbadox’s FDA approval.
In the meantime, Phibro said it has "continued an ongoing process of responding collaboratively and transparently to FDA’s Center for Veterinary Medicine (CVM) inquiries to provide extensive and meticulous research and data that confirm the safety of carbadox and that no carbadox residues of carcinogenic concern can be detected at the end of the labeled withdrawal period."
The company said it welcomes FDA's decision to hold this hearing and hopes FDA will take stakeholder input into consideration, engaging with scientists, swine producers and others regarding the safety and efficacy of carbadox.
"We understand FDA has put the 2020 Proposed Order on hold. We are confident that this hearing will affirm and support the continued safe use of carbadox in the market. In the event that following this hearing FDA continues to assert that the carbadox should be removed from the market, Phibro is entitled to and expects to have a full evidentiary hearing on the merits before an administrative law judge," Phibro said in a release.
Phibro added that it will continue to defend swine producers’ ability to use Mecadox to protect the health and welfare of their animals and is confident that it will be able to reaffirm that the use of carbadox is safe as approved.
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