The U.S. Food and Drug Administration recently reported an initiative to address the prevalence of unapproved animal drugs marketed in the United States.
The FDA says it is concerned that the safety and effectiveness of these marketed products have not been demonstrated. An FDA approval ensures that the drug’s strength, quality and purity are consistent from batch to batch and that the drug’s labeling is appropriate and truthful, according to the agency.
As part of the initiative, the FDA is soliciting comments from all stakeholders, including veterinary professionals, the regulated industry and the public, on strategies to address this issue. Specifically, the FDA is requesting comments on approaches for increasing the number of currently marketed animal drug products that have legal marketing status.
The focus is not on revising the current new animal drug approval process, the FDA noted, but to explore additional mechanisms that use FDA’s existing regulatory framework as well as strategies not currently employed by the agency to increase the number of approved or otherwise legally marketed animal drugs.
The FDA is also requesting comment on the use of limited enforcement discretion as an element of the overall strategy. This means that under limited circumstances, the FDA may exercise enforcement discretion to maintain access to essential unapproved animal drugs while drug companies work to get these drugs on the market legally.
Comments can be submitted at www.regulations.gov, under Docket No. FDA-2010-N-0528. Deadline is Feb. 18.
The FDA has also launched an Unapproved Animal Drugs web page here, which sets out to explain what illegally marketed unapproved animal drugs are and why the FDA is concerned about these drugs.
In addition, the web page covers the difference between an animal drug and an animal device, and the risks of a company marketing an unapproved animal drug as an animal device.