Regulatory Focus™ > News Articles > Judge Calls FDA Decision on Antibiotics 'Arbitrary and Capricious,' Urges Reconsideration

Judge Calls FDA Decision on Antibiotics 'Arbitrary and Capricious,' Urges Reconsideration

Posted 05 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has suffered its second setback in as many months after Magistrate Judge Theodore Katz of the District Court of New York ordered the agency to reconsider two petitions which seek to ban the use of antibiotics in animals.

FDA had rejected both petitions, respectively submitted to the agency in 1999 and 2005, citing "the time and expense required to evaluate individual drug safety and to hold formal withdrawal proceedings," reports Reuters.

Katz said he disagreed with the actions the agency had taken, and decided it had acted without merit in its respective decisions. "Denying the petitions on the grounds that it would be too time consuming and resource-intensive to evaluate each individual drug's safety, and withdraw approval if a drug was not shown to be safe, is arbitrary and capricious," explained Katz in his ruling.

Under the new ruling, FDA will be charged with evaluating the safety risks of antibiotics used in animals and deciding whether the drugs are safe for use in animals. Katz also demanded FDA "provide a reasoned explanation as to why the Agency is refusing to make such a finding" if it believes the use of antibiotics is safe in animals.

Katz's ruling is his second in just over two months against FDA. In a 22 March ruling, Katz said FDA must either make plans to withdraw approval for the use of most antibiotics in animal feed or withdraw approval for non-therapeutic use of those antibiotics. That decision was focused on FDA's abandonment of a process started in 1977 to phase out the use of antibiotics in animal feed, and Katz said he was troubled by the trend of evidence against the use of antibiotics in animals.

"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 defended its actions to Katz, saying it had abandoned the project to focus on achieving the same end through different means, but Katz ordered them to complete the original process. FDA issued voluntary guidelines against the use of antibiotics in animals on 11 April 2012, and appealed the 22 March ruling on 21 May 2012.

It is unclear whether FDA will appeal this decision as well or if it will carry out the safety analysis called for by Katz.

Read more:

Reuters - FDA urged to rethink on antibiotics in animal feed

WSJ - FDA Ordered to Rethink Petitions on Farm Antibiotics

Regulatory Focus newsletters

All the biggest regulatory news and happenings.