This past Wednesday, March 1st, EPA and FDA’s Center for Veterinary Medicine hosted a joint information session for industry stakeholders regarding a proposed change of agency for oversight of animal health products, such as flea/tick spot-ons and collars. An estimated 600 products would be impacted by this proposal, expected to take approximately 5 years to implement. This is arguably the biggest proposed change in oversight for these products since the two agencies first entered a Memorandum of Understanding (MOU) in 1971. Implications of this proposal may be significant and far reaching, including changes to safety monitoring and reporting, and which agency oversees application filings, approval, and inspection procedures, amongst many other aspects.
Prior to the meeting, the agencies released a whitepaper outlining their reasoning, current challenges with oversight of these products, and expected benefits of the proposal. The agencies have asked for stakeholder input by way of a public comment period on the Federal eRulemaking Portal by April 24th. We strongly encourage you and your teams to read the whitepaper as soon as possible. Please be sure to reference Docket No. EPA-HQ-OPP-2023-0103 in any comments you may leave on the portal. They have additionally announced a virtual public meeting scheduled for March 22nd. Registration for the public meeting is required by 11:59pm EST on March 15th.
SafetyCall’s regulatory team is closely monitoring this proposal and will continue to send out pertinent updates as they happen. Please contact us should you wish to set up a discussion about implications this proposal may have for safety monitoring and reporting of adverse events with your products.
