ISVMA Illinois State Veterinary Medical Association
  Join the ISVMA
byline

 

 

February 15 , 2011

 

Volume VIII, No. 13

 

E-Source

An electronic newsletter highlighting veterinary issues for Illinois veterinarians

Greater Pewee
Click the image above to become a fan of the ISVMA on Facebook!

In this Issue

TAKE ACTION: FDA Looks to Reduce Use of Unapproved Animal Drugs - Docket No. FDA 2010-N-0528

Veterinarians Applaud Movement by Senate to Repeal 1099 Requirement: Urge House to Act as Well

Illlinois Regional Agro-Terrorism Workshop

Arizona Man Aims to Reunite Owners, Lost Pets by Going Digital

First Confirmed 2011 Case of H1N1 Influenza Virus Infection Reported in Domestic Cat in Wisconsin

Livestock Boom Risks Aggravating Animal 'Plagues,' Poses Threat to Food Security and World's Poor

About the Photo

Contact Us

peter@isvma.org

 

 

 

TAKE ACTION: FDA Looks to Reduce Use of Unapproved Animal Drugs
Docket No. FDA-2010-N-0528

AVMA disapproves of time allotment
Comments Not Accepted after Friday, February 18!

Compounded medicines = Unapproved Animal Drugs. According to Wade Siefert, RPh of Preckshot Professional Pharmacy (Peoria IL) and faithful annual exhibitor at the ISVMA’s annual conventions, the FDA defines all compounded medications – as well as the extra-label use of commercially available products – to be “unapproved” animal drugs.

On December 20, the FDA published a request for comments in the Federal Register on Unapproved Animal Drugs. For veterinarians who rely upon custom preparations of medicines using Active Pharmaceutical Ingredients, or bulk ingredients, speak up and be counted. The FDA wants only FDA-approved finished products to be used in veterinary products; they’re concerned that the safety and effectiveness of animal drug products marketed in the US without FDA approval has not been demonstrated.

As stated in the Federal Register, the types of unapproved animal drugs marketed include, but are not limited to: injectable vitamins; various topical solutions, shampoos, and liniments; electrolyte and glucose solutions; and antidotes. In addition, there are a variety of anti-infective and other animal drug products marketed for use in a variety of animal species.

The FDA affirms that many unapproved animal drugs are, and some continue to be, the standard of care in treating animals, and some are essential to protecting animal health and ensuring an adequate food supply; however, they are seeking ways to increase the number of approved animal drugs to minimize the “unapproved” drugs used for animals.

“The FDA’s intended actions will eliminate most of the veterinary compounding that takes place currently in this country,” says Siefert, who is also Vice President of the International Academy of Compounding Pharmacists. “Treatment options will be mostly eliminated, and the quality of medications that could still be prepared would be negatively impacted severely.”

Siefert learned of the notice published by the FDA just this week, and was astonished that the opportunity for comments was so limited. So is the AVMA. On December 28 an official request was made by the AVMA to extend the comment period. To access the AVMA’s official correspondence, go to:

http://www.regulations.gov/#!documentDetail;D=FDA-2010-N-0528-0012

In his letter to the Division of Dockets Management, Executive Vice President of the AVMA W. Ron DeHaven emphasizes this brevity of opportunity. “We believe that the notice, which seeks to explore possible new mechanisms that would increase the number of approved or otherwise legally marketed animal drugs, warrants thoughtful consideration due to the complexity of the subject matter.”

Post a comment online BEFORE FRIDAY, FEBRUARY 18, 2011 when the comments window closes. Let the FDA know how additional limits placed on veterinary compounding from commercially-available, finished drug products will impact the ability to effectively treat, and the quality of care administered to, the animals requiring medical care.

Open the link at http://www.regulations.gov/#!submitComment;D=FDA-2010-N-0528-0001 today.

FDA is soliciting public comment on potential actions the Agency can take to help achieve the goal of obtaining legal marketing status, as appropriate, for unapproved animal drugs that are currently being marketed in the United States.

The Agency asks that comments be as detailed as possible.

FDA is also specifically requesting comments and information on the questions and subjects below.

1. Monographs
Certain over-the-counter (OTC) drugs for humans are marketed under monographs that establish the conditions under which these drugs are generally recognized as safe and effective and not misbranded. The monographs specify active ingredients, dosage forms, product strengths, indications for use, labeling, and other conditions.
Does published literature of sufficient quality exist for some currently marketed unapproved animal drugs such that monographs might be a feasible approach? For which drugs might this be feasible? What are the attributes that make the published literature suitable for this purpose? What criteria should be used to determine whether an animal drug is potentially suitable for a monograph to ensure that quality, safety and effectiveness would not be compromised in the absence of premarket review?

2. Use of Publicly Available Information
In some cases, human prescription drugs have been approved and marketed after FDA reviewed the existing literature and data regarding a particular drug or class of drugs.
Does published literature of sufficient quality exist for some animal drugs that could be used to support safety and effectiveness evaluations for these currently unapproved marketed drugs? For which drugs might this be feasible? What attributes make published literature of sufficient quality to contribute to such an evaluation?

Veterinarians Applaud Movement by Senate to Repeal 1099 Requirement; Urge House to Act as Well

(SCHAUMBURG, Illinois) February 15, 2011—The American Veterinary Medical Association (AVMA) applauds the U.S. Senate for taking action to begin the process of repealing an unpopular requirement of the health care reform bill.

In his State of the Union address, President Barack Obama stated that he was willing to change the new 1099 reporting requirement of the Affordable Care Act, slated to go into effect in 2012. The U.S. Senate didn’t hesitate to act, voting 81 to 17 with bipartisan support to attach an amendment to the FAA reauthorization bill to repeal the controversial 1099 requirement. The Senate is expected to complete its work on the reauthorization bill in the next month.

“Veterinarians will be hard hit by the massive amount of red tape this requirement will create if it isn’t repealed,” explains Dr. Larry Kornegay, president of the AVMA. “The damage created by this requirement on small business people, such as veterinarians, far outweighs the tax revenues it would generate.”

The AVMA is joined in opposition to this new 1099 requirement by numerous organizations representing small businesses.

“The AVMA just released its 2011 Report on Veterinary Compensation, and it reveals that many of our veterinarians are already hurting during this recession. This isn’t a good time to make it even more costly and difficult to be a small business owner in America,” explains Dr. Ron DeHaven, chief executive officer of the AVMA. “We are encouraged that there is bi-partisan movement toward repeal of this costly and burdensome 1099 requirement in both the Senate and House of Representatives.”

For more information on the 1099 legislation, visit www.avma.org/advocacy/avma_advocate.

Illinois Regional Agro-Terrorism Workshop

The Federal Bureau of Investigation - Springfield Division and the Illinois Department of Agriculture are presenting a Regional Agro-Terrorism Workshop from 8:30 am to 3:00 pm
on February 22, 2011 in Carlyle, IL at the Carlyle Mariner's Village, 1 Resort Drive, Carlyle, IL 62231 and again on February 23, 2011 in Pittsfield, IL at the Pike County Farm Bureau, 1301 East Washington, Pittsfield, IL 62363. For more information and to register visit: www.illinoisworkshop.org.

Arizona Man Aims to Reunite Owners, Lost Pets by Going Digital

(By Robert Scott, ABC15.com)
MESA, AZ - An East Valley man is hoping his new product can help reunite lost pets with their owners.

Dirk Van Vorris is manufacturing digital pet identification tags that can be scanned by any smartphone. Once scanned, any information the pet’s owner put on the tag appears on the screen of the smartphone.

The tag is limited to 3,500 characters but should leave plenty of room for contact information so a good Samaritan can return the pet to its owner.

“With these tags, anyone who has a smartphone can scan the bar code on the tag and all the information comes up," Van Vorris said. "You can contact the owner and hopefully get the pet returned in record time.”

The tags run either $12.50 for a white tag or $14.00 for a colored tag.

For more information, visit www.hightechtags.com.

First Confirmed 2011 Case of H1N1 Influenza Virus Infection Reported in a Domestic Cat in Wisconsin

ScienceDaily (Feb. 11, 2011) — Increasing numbers of domestic livestock and more resource-intensive production methods are encouraging animal epidemics around the world, a problem that is particularly acute in developing countries, where livestock diseases present a growing threat to the food security of already vulnerable populations...Read More

Livestock Boom Risks Aggravating Animal 'Plagues,' Poses Threat to Food Security and World's Poor

ScienceDaily (Feb. 11, 2011) — Increasing numbers of domestic livestock and more resource-intensive production methods are encouraging animal epidemics around the world, a problem that is particularly acute in developing countries, where livestock diseases present a growing threat to the food security of already vulnerable populations...Read More

Contact Us

This issue of the ISVMA’s E-SOURCE is a free member benefit to its veterinarian and certified veterinary technician members. Members are encouraged to share this with other industry professionals; however, subscriptions are not available for sale.

For members not on the recipient list, forward your current e-mail address to info@isvma.org and ask to receive the E-SOURCE newsletter.

For members who wish to be removed from the electronic distribution list, notify the ISVMA office via email to info@isvma.org and request to be removed from the ESOURCE distribution list.

         
     

Illinois State Veterinary Medical Association
1121 Chatham Road
Springfield, IL 62704

Phone: (217) 546-8381

Copyright © 2003-2006 Illinois State Veterinary Medical Association

Web design by Rareheron Web Design, Portland, Oregon