The U.S. Food and Drug Administration announced this week it is inviting public comment on a pair of potential changes in policy regarding approval of drugs used in food-animal production. Each public comment period opens today, September 9.
The first proposed change would modify the procedures and requirements for the approval of combination drug medicated feeds. Currently, according to background information from the FDA, the use of multiple new animal drugs in the same medicated feed requires animal drug sponsors to seek approval for each new animal drug in the combination and seek a separate approval for the combination drug itself.
According to the document to be published on Sept. 9 in the Federal Register, FDA and industry have agreed to explore changes to the approval process for the use of a combination drug medicated feed, considering changes “intended to allow combination drug medicated feeds to be made available to the end user in the most efficient manner possible while protecting and promoting the public health.”
The FDA is accepting public comments on this topic beginning on September 9, 2014, and the comment period will close on September 9, 2015, with draft recommendations developed September 30, 2016.
Also beginning on September 9, FDA is seeking comments on potential changes to conditional approvals for new animal drugs. Currently, conditional approvals are only available for new animal drugs that are intended for use in minor species or for minor uses, such as rare diseases, in major species such as cattle. A conditional approval, according to FDA, allows a drug manufacturer to market its new animal drug before submitting the effectiveness data necessary for a full approval, but after proving the drug is safe in accordance with the full FDA approval standard and showing that there is a reasonable expectation of effectiveness.
According to the document filed Sept. 9 in the Federal Register, the FDA is exploring the use of statutory changes to expand the use of conditional approval to appropriate categories of new animal drugs beyond those intended for use either in minor species or for minor uses in major species.
Specifically, the agency invites comments on the following specific questions:
- Which categories of new animal drugs, if any, beyond those intended for minor species or minor uses in major species, should be considered by FDA for conditional approval in accordance with the current conditional approval process and why?
- How would expanding conditional approval positively or negatively affect animal health?
On this issue, the FDA is accepting public comments beginning on September 9, 2014 and ending on March 9, 2015. The agency intends to release draft recommendations by September 30, 2015.