Does FDA plan to take similar action on other drugs or classes of drugs?
FDA recognizes that it is very important that veterinarians have access to effective therapies for assuring the health and welfare of animals. The ability of veterinarians to use drugs in an extralabel manner, under the provisions of AMDUCA, is a critical mechanism for enabling access to such therapies. With this in mind, FDA carefully considers any decision to exercise its authority to limit extralabel use and, does so only when it believes it is necessary to protect the public health. Given the importance of the cephalosporin class of drugs to human health, FDA felt that action in this particular case was needed to help curb the development of cephalosporin-resistant zoonotic bacteria. Action by FDA to prohibit the extralabel use of this particular class of antimicrobial drug does not signal that the agency intends to take similar action for other antimicrobial drugs or classes of drugs. • How will this rule impact further antimicrobial drug development for food-producing animals? Th
