Regulatory Focus™ > News Articles > FDA Appeals Antibiotic Decision, Earning Congresswoman's Ire

FDA Appeals Antibiotic Decision, Earning Congresswoman's Ire

Posted 01 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) quietly moved to appeal a ruling by US Magistrate Judge Theodore Katz, who said the agency must either plan to withdraw its approval for most antibiotics used in animal feed or withdraw approval for their non-therapeutic applications.

The agency, in conjunction with the US Department of Health and Human Services, filed an appeal with the US Second Circuit Court of Appeals in New York on 21 May. The case was originally filed by the Natural Resources Defense Council (NRDC) and four other groups who sought a ban in light of the antibiotics' potential to generate antibiotic resistant strains of disease.

In his 22 March 2012 ruling, Katz agreed with their concerns, saying FDA had failed to follow its own findings and processes. The agency had started to develop regulations on the use of antibiotics in animal feed in 1977, but the process lay mostly dormant until it was formally dissolved in 2011 by FDA.

"In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence that the FDA has changed its position that such uses are not shown to be safe," wrote Katz in his ruling.

FDA's appeal has received swift push-back from Congresswoman Rep. Louise Slaughter (D-NY), who said she was disappointed but not surprised at the agency's decision to appeal.

"They've buried their heads in the sand and ignored the threat of antibiotic resistance for well over 30 years," Slaughter told The Hill. "But avoiding this problem […] only increases the threat to our public health."

"As far as I'm concerned, FDA's decision to appeal [...] is nothing short of a dereliction of duty," added Slaughter. 

Read more:

The Hill - Dem lawmaker blasts FDA for 'ignoring' antibiotic resistance in recent court appeal

Regulatory Focus - Judge Orders FDA To Remove Antibiotics from Animal Feed

Food Safety News - FDA Appeals Mandate to Ban Three Animal Antibiotics

Appeal Text Filed With 2nd Circuit Court of Appeals

Regulatory Focus newsletters

All the biggest regulatory news and happenings.