My Horse Daily Says to Just Say No

Just Say No to (Unapproved) Drugs for Your Horse

February 28, 2013

The recent human meningitis outbreak, caused by the injection of contaminated compounded steroid products prepared by the New England Compounding Center, has put compounding pharmacies into the daily headlines.
But it isn’t just human drugs consumers should be concerned about. Compounding pharmacies prepare drugs for horses, as well. In 2009, a vitamin and mineral supplement prepared by Franck’s Compounding Lab in Ocala, FL included an excessive amount of one ingredient (selenium) that resulted in the death of 21 polo ponies.
In other cases of questionable drug safety, illegal products that claim to be “the same as” name brand drugs are marketed to consumers, sometimes with devastating results. In 2006, a reported six horses died as a result of using an illegal clenbuterol product.
Unfortunately, in these cases, the results of using non U.S. Food and Drug Administration (FDA) approved drugs were tragic. In other instances, while the unapproved and unproven products may not be particularly harmful, they may not contain the labeled amount of active ingredient, or do what they claim to do.
Studies presented at the American Association of Equine Practitioners (AAEP) Convention in prior years have shown a wide range in the pharmaceutical equivalence of compounded drugs when compared to brand name drugs. In 2003, Scott Stanley, PhD, presented findings from a study evaluating compounded versions of the FDA-approved drugs ketoprofen, amikacin and boldenone. In the case of ketoprofen, one compounded preparation contained just one-half of the expected concentration.
With amikacin, some compounded preparations had less drug, between 59 percent and 76 percent of what was stated on the label. Other compounded versions of the drug had more than the stated concentration: 112 percent and 140 percent.
Dr. Stanley conducted similar research on compounded versions of omeprazole, presenting his findings at the 2011 AAEP Convention. The compounded omeprazole products ranged from more than 100 percent to approximately 63 percent of the concentration claimed on the label.
After 60 days, the compounded versions lost potency, with the amount of active ingredient varying from 82 percent to as little as 17 percent.
At the 2012 AAEP Convention, Dr. Stanley presented results from a similar study, this one comparing compounded formulations of clenbuterol with the FDA-approved version. His findings showed the compounded formulations varied from containing as little as 32 percent of the labeled concentration up to more than 316 percent of the labeled concentration.
“What these studies have shown is that compounded versions of equine drugs, in many cases, do not contain the proper concentration of the active ingredient,” says April Knudson, DVM, equine specialist, Merial Large Animal Services. “If they don’t have enough of the active ingredient, it’s a natural conclusion they won’t work as well, if at all. If they have too much of the ingredient, it’s possible there will be a detrimental effect on the horse’s health, depending on the ingredient,” she says.
Additionally, merely containing the same active ingredient as a brand name drug does not guarantee efficacy or safety. The proper formulation is often an essential part of making a safe and efficacious product.
How can horse owners be sure they are getting a product that is safe and will do what it claims on the label? By making sure that product is FDA approved.
Drugs that are approved by the FDA are:

• Tested in the target animal in field trials and in the laboratory.
• Manufactured according to Good Manufacturing Practices, which ensures consistency.
• Manufactured in inspected facilities that meet FDA guidelines.
• Labeled with information that can be scientifically substantiated.
• Advertised in such a way as to not be false or misleading.
• Monitored following approval for adverse events.

Because many of these unapproved drugs are made to look like the approved drugs, horse owners should be wary and do their homework.

Whether a product has been FDA-approved can be determined by checking the searchable database at AnimalDrugs@FDA (http://www.accessdata.fda.gov/scripts/animaldrugsatfda/. Most generic and brand name drugs also feature a number on the label indicating FDA approval. In the case of brand name drugs, look for the six-digit New Animal Drug Application (NADA) and for generics, the Abbreviated New Animal Drug Application (ANADA) number.

“Horse owners have a lot of financial and emotional investment in their horses,” says Dr. Knudson. “Taking some time to research the products available and make educated decisions should help them keep their horses healthy in the long run.”

For more information about the types of products available and the importance of FDA approval, go to equinedrugfacts.com.

Source found here

FDA MATTERS: The State of the FDA—February 2013 Funding Agency Mission “At Risk”, Says Alliance President

 FDA’s mission is “at risk” because of inadequate funding. So says Alliance for a Stronger FDA President Diane Dorman, testifying before the FDA Science Board. Her remarks come 5 years after the Science Board made a similar declaration, concluding that decades of underfunding had left FDA without the resources to fulfill its mandate and make science-based decisions.

Congress responded with more monies for the agency, but since then the FDA’s workload has increased even faster. The current threat to FDA comes from two sources: four major new laws to implement since 2009; and changes in the environment in which FDA operates, notably acceleration of globalization and increasing scientific complexity.

Ms. Dorman’s remarks are reprinted below. If you care about FDA, FDA Matters urges you to read her testimony, go to the Alliance’s site (www.StrengthenFDA.org) and join.

Testimony of Diane E. Dorman

President, Alliance for a Stronger FDA

Before the

Science Board of the U.S. Food and Drug Administration

February 27, 2013

Good afternoon and thank you for the opportunity to address the FDA Science Board.

My name is Diane Dorman and I am President of the Alliance for a Stronger FDA, as well as Vice President for Policy at the National Organization for Rare Disorders. The Alliance is a 200-member coalition of all FDA’s stakeholders—consumers, patients, health professionals, trade groups and industry. Our sole purpose is to advocate for increased appropriated resources for the FDA.

When we started in 2006, FDA appropriations stood at slightly less than $1.5 billion for an agency tasked with overseeing 100% of drugs, vaccines, medical devices, and personal care products and 80% of our nation’s food supply. Altogether, the products and industries regulated by FDA account for nearly 25% of all consumer spending in the United States.

In short, FDA was the victim of decades of underfunding. It was quite small, despite its vital, complex world-wide responsibilities. Presidents weren’t asking for nearly enough money for FDA and Members of Congress were responding by giving the bare appropriations that had been asked for.

The Alliance’s goal was to change this situation by galvanizing the FDA’s broad stakeholder community to focus attention on the consequences of underfunding. We never doubted the accuracy of our analysis or the importance of our cause.

Nonetheless, it was immensely helpful when–18 months after our founding–the FDA Science Board released its own report in November 2007. As the media described it—the FDA’s own Science Board evaluated the agency’s capacities and responsibilities and declared that the agency’s mission was “at risk.” The word “crisis” was often used and was an appropriate description of the situation.

Subsequently—and with the Alliance’s broad stakeholder advocacy—the prospects for FDA improved. Policymakers acknowledged the underfunding and acted aggressively to reverse it.

Continue reading testimony here