February 15, 2015

 

 Senators doubt FDA can control antimicrobial use

By Greg Cima

Posted Jan. 28, 2015

Three senators have expressed doubt federal authorities can or will ensure that veterinarians administer antimicrobials to livestock only when appropriate.

Senators Elizabeth Warren, Dianne Feinstein, and Kirsten E. Gillibrand said in a mid-December 2014 letter to Defense Secretary Chuck Hagel, Agriculture Secretary Tom Vilsack, and Health and Human Services Secretary Sylvia Mathews Burwell that the senators also were concerned that the Food and Drug Administration lacks access to data needed to evaluate agency actions on drug resistance. The secretaries are co-chairs of the federal Task Force for Combating Antibiotic-Resistant Bacteria, which was created by executive order this past September and instructed to develop a plan to address drug resistance risks. 

 (Photo by Greg Cima)
 

“The way antibiotics are used in animal agriculture poses a clear threat to human health and it is critical that the National Action Plan directly addresses gaps in current policies designed to curb such misuse and over-use,” the letter states.

FDA spokeswoman Megan Bensette said the FDA would respond directly to the senators, and she declined to provide further comments on the letter. Asked how, in general, the FDA tries to ensure appropriate antimicrobial use, Bensette said the FDA believes engaging the veterinary community is the most efficient and effective way to implement its judicious use strategy. The FDA plans to continue working with veterinary medical groups, such as the AVMA, to ensure that veterinarians provide appropriate oversight of drug administration in food animals, and the agency will support efforts to educate veterinarians on judicious use principles and include antimicrobial stewardship programs in the veterinary medical curriculum.

She also noted that the FDA can act in response to violations of regulations on veterinary feed directives and extralabel use.

The senators said in the letter that the FDA, in promoting judicious antimicrobial use, plans to work with veterinary and agriculture groups that have voiced doubts about the need to reduce antimicrobial use and the effectiveness of FDA policies on reducing use. One of the sources cited is an AVMA FAQ document that states that increasing restrictions on antimicrobial use removes a tool for veterinarians and that little or no evidence suggests restricting or eliminating antimicrobial administration to livestock would improve human health or reduce the risk of antimicrobial resistance to humans.

AVMA CEO Ron DeHaven provided a statement that the AVMA has strongly supported efforts to implement veterinary oversight of medically important antimicrobials.

“We are disappointed that our statements regarding reduction of or restrictions on the use of antimicrobials have been misconstrued,” he said.

“This has raised doubts about our steadfast commitment to appropriate antimicrobial use, rather than reflecting the AVMA’s goals of enhancing judicious use by requiring veterinary oversight and protecting public health, animal health and welfare, and food safety.”

The FDA has threatened regulatory action against any drug companies that do not, by December 2016, agree to remove over-the-counter access to livestock-use antimicrobials considered important for human medicine and remove approvals for production uses of such drugs in livestock feed or water.

The senators said the FDA had taken positive steps but may lack authority to ensure that veterinarians adhere to agency criteria on administering antimicrobials for disease prevention. Their letter states that, even when production uses are removed from antimicrobials considered important for human medicine, some approved disease prevention uses of those drugs allow for “the same continuous low dose antibiotic regimens known to facilitate the development of antibiotic-resistant bacteria.”

Last November, the Pew Charitable Trusts also published a report, “Gaps in FDA’s antibiotics policy,” that states that “The lines between disease prevention and growth promotion are not always clear.” The Pew analysis states that, of 287 antimicrobial drug products that will no longer be available for production uses and will require veterinarian oversight by the end of 2016, 66 are approved for disease prevention administration at dosages that overlap with their production approvals and have no limits on treatment duration.