Navigation Links
FDA Denies Citizen Petitions on Animal Antibiotics
Date:11/9/2011

CHICAGO, Nov. 9, 2011 /PRNewswire-USNewswire/ -- On Monday, in a disappointing move, the U.S. Food and Drug Administration (FDA) denied two citizen petitions that asked the Agency to ban certain uses of antibiotics in food animals.  The petitions, filed in 1999 and 2005, urge the FDA to withdraw the approvals for antibiotics given to animals in feed or water for purposes other than disease treatment if the antibiotics are also used in human medicine. The petitions were filed by Environmental Defense, Center for Science in the Public Interest, Food Animal Concerns Trust, and the Union of Concerned Scientists along with other groups because of evidence showing that using antibiotics in this way in food animals can lead to the spread of difficult to treat resistant infections in humans.

The response to these long-standing citizen petitions came after several of the petitioners filed suit in May against the FDA for not responding.  In addition to demanding the FDA respond to the citizen petitions, the lawsuit asks that the FDA take action on the Agency's own safety findings from 1977 and withdraw approval for most uses of penicillin and tetracyclines in animal feed. 

In denying the petitions, the FDA did not challenge the need to reduce antibiotic use, but instead argued that the withdrawal process itself was too expensive and resource intensive. Rather than implementing its formal process for taking drugs off the market, the Agency stated that it plans "to work with sponsors who approach FDA and are interested in working cooperatively with the Agency to phase out production uses of medically important antimicrobials." FDA has released a draft version of a document that describes its plan to reduce use through the voluntary withdrawal by pharmaceutical companies of currently marketed uses of antibiotics in feed.  

"Instead of adhering to its mission to protect consumers, the FDA is waiting for the drug companies to voluntarily do what the Agency is legally mandated to do. There is absolutely no reason to believe that drug companies will voluntarily reduce sales of antibiotics and act against their own financial self-interest. Without reductions in antibiotics used it is impossible for there to be any public health benefit," said Steven Roach, FACT's Public Health Program Director. "For this reason we do not see the FDA's plan as an answer to the petitions or the problem of antibiotic resistance."

In addition to bringing suit against the FDA, FACT also supports the Preservation of Antibiotics for Medical Treatment Act. This federal legislation, if passed, would require the FDA to address non-therapeutic antibiotic use and make it easier for the Agency to withdraw animal antibiotics that are found to be unsafe from an antibiotic resistance standpoint.

"Reducing antibiotic overuse is essential for making sure antibiotics will keep working for years to come – to treat our sick children, families and animals. It is outrageous that the FDA considers voluntary self-regulation by drug companies to be enough. It is clearly not," said FACT's Executive Director Richard Wood.

Food Animal Concerns Trust (FACT) is a Chicago based non-profit that promotes humane and healthy farms through science-based advocacy, consumer education, and support for humane farmers. For more information visit www.foodanimalconcerns.org.

Contact: Jacki Rossi, (773) 525-4952 w, (219) 218-3824
jrossi@foodanimalconcerns.org



 


'/>"/>
SOURCE Food Animal Concerns Trust
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Third Circuit Denies Mylan Motion for Interim Injunction
2. US Supreme Court Denies Certiorari and Thereby Leaves in Place Second Circuit Ruling That Novartis Pharmaceuticals Corporation Must Pay its Sales Representatives Overtime Compensation
3. GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition
4. Montana Supreme Court Decision Endangers Most Vulnerable Citizens
5. Senate Rejects Bulk Imports of Medicine from Canada, but Personal Importation Remains a Popular Option for U.S. Citizens
6. Abbott 2009 Global Citizenship Report Highlights Companys Progress in Redefining Responsibility
7. Warner Chilcott Announces Receipt of FDA Response to Citizen Petition
8. Pentasa(R) - Shire Receives Ruling From FDA on Citizens Petition
9. Abbott Included on the Dow Jones Sustainability Indexes for Six Consecutive Years in Recognition of Leading Corporate Citizenship Performance
10. Peptimmune Files Citizen Petition Regarding Generic Copaxone and Demonstrates Significant Enabling Technology for Biological Characterization of Copaxone
11. Sinovac Selected by Beijing CDC to Supply Seasonal Flu Vaccine Anflu(R) to Beijing Citizens
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... , Feb. 12, 2016  Aralez Pharmaceuticals Inc. (Nasdaq: ... announced the Company will ring the Nasdaq Closing Bell ... New York at 4:00 p.m. ET on ... Aralez. Adrian Adams , will perform ... 3:50 to 4:00 p.m. ET.  A live webcast will ...
(Date:2/12/2016)... , 12 februari 2016 ... een toonaangevende leverancier van productie en ontwikkeling ... industrieën, kondigt vandaag een uitbreiding aan van ... haar locatie in Charleston, SC ... geleid tot meerdere recente investeringen. ...
(Date:2/12/2016)... 2016 Indiso ltd ... ungedeckten medizinischen Bedarf bei Lungen- und Atemwegserkrankungen ... Forschungsprogramms bekannt. Das Programm, das sich mit ... respiratorischen Funktionen und anderer klinischer Parameter. ... das sich auf den ungedeckten medizinischen Bedarf ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... Every winter, someone is killed, injured or ... West Penn Burn Center, part of the Allegheny Health Network, has partnered with ... the “Space Heaters Need Space” campaign. , “Space Heaters Need Space” aims ...
(Date:2/12/2016)... ... February 12, 2016 , ... AssureVest Insurance Group, a locally owned ... charity drive that will raise funds earmarked to purchase computers and software for Mrs. ... , “My school is in a low-income area and has more than 60 2nd ...
(Date:2/12/2016)... ... ... Vail knee specialist Robert LaPrade, MD, PhD was named one ... consists of physicians establishing, leading and partnering with ambulatory surgery centers across the United ... Center, also known as an ASC, is a modern health care facility focused on ...
(Date:2/12/2016)... ... February 12, 2016 , ... Young Asset Protection, a full ... of the latest charity campaign in their community enrichment program. Art Expression utilizes ... worthy cause are currently being accepted at: http://artexpressioninc.org/ . , Art Expression ...
(Date:2/12/2016)... ... February 12, 2016 , ... Miami Dental Specialists is excited to bring patients ... office. Beginning in January, Miami Dental Specialists will offer the non-metal implants as a ... office to be chosen by the dental implant manufacturer, Straumann, to bring this cutting-edge ...
Breaking Medicine News(10 mins):