FDA Should Look at Animal Antibiotic Labels: Pew
A Pew Charitable Trusts analysis says that one-third of animal antibiotic drug labels will not meet judicious use requirements that are part of an agency voluntary guidance intended to ensure the judicious use of antibiotics that are important to humans in the production of food animals. The report says the guidance that takes effect 1/1/17 asks animal drug companies to make two changes for antibiotics shared by humans and animals: (1) remove indications for promoting growth from the labels of the antibiotic products and (2) require veterinarians to oversee addition of the drugs to feed and water for any reason. Although the guidance is voluntary, Pew says, animal drug companies have already agreed to comply and producers and veterinarians will have to follow the revised labels.
The report says that even after the policy changes take effect, a number of labels will remain problematic and some injudicious uses may persist. “Of the 389 labels for medically important antibiotics, about 240 define the conditions for use in a manner consistent with judicious use principles,” the report says. “However, more than 140 labels do not meet FDA’s judicious use standards, and around three-quarters of these potentially problematic labels are for pioneer drugs. This is an important distinction, because the label of a generic drug has to reflect that of the pioneer drug on which it is based.”
Pew says that more than half of the problematic labels do not contain a growth promotion claim and therefore will not be affected by, or potentially removed from the market because of, the policy changes mandated by the guidance. It says that fact is important because some companies may choose to completely withdraw certain affected drugs from the market rather than revise their labels to remove growth promotion claims. “Even in the unlikely event that every drug company decides to completely withdraw all labels that include growth promotion claims,” it says, “almost half of the labels identified in this analysis that continue to promote other problematic uses would remain on the market.”
It says that of the 389 labels, over 100 lack adequate restrictions on the duration of use, several labels do not specify a narrowly defined dosage, and 80 labels raise concerns about whether the specified indication is judicious.
According to FDA data, the report says, the amount of medically important antibiotics sold for food-producing animals increased 23% between 2009 and 2014, the last year for which data are available. “Because potentially problematic labels will remain after full implementation of the guidance, it is crucial to take additional steps to address them now,” Pew says. “This analysis shows that the problem is manageable and identifies the biggest issue areas, which can help FDA decide how to prioritize resources for the review and revision of antibiotic labels. For example, because use of feed drugs in ways that deviate from label instructions is illegal, review of these labels may be a particular priority for FDA…. FDA has publicly committed to ensuring that labels follow the judicious use of antibiotics in food animals, in particular with respect to establishing appropriate conditions of use. The agency should go further and announce a concrete plan and timeline for making all label revision changes, regarding duration limits and other aspects of appropriate use, as quickly as possible and follow through accordingly.”