Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Friday, May 3, 2013
HORSE HEALTH Choosing Joint Health Products May 2, 2013 Find out how to make the best choice between FDA-approved innovator drugs, FDA-approved generic drugs, medical devices or compounded products.
When a horse or companion animal becomes sick or lame, you turn to your veterinarian for a diagnosis and the best, proven treatment to make your animal better.
But, just because a product is available for purchase doesn’t make it a proven product or the right product to treat the problem. So, do you treat with an FDA-approved innovator drug, an FDA-approved generic drug, a medical device or a compounded product?
In considering this question, Dr. Jeffrey Berk, a veterinarian at Equine Medical Associates in Lexington, Kentucky, says horse owners need to consider two things very carefully.
“When considering an alternative treatment, veterinarians and horse owners need to understand they are not guaranteed the same level of safety or quality — i.e. potency and purity — as you would with an FDA-approved product,” says Dr. Berk, who is a member of the Professional Conduct & Ethics Committee of the American Association of Equine Practitioners.
Some experts estimate that it takes four to six years and millions of dollars to get anFDA-approved animal drug from the laboratory to the marketplace. Most of the money is spent on conducting studies that prove the drug’s effectiveness in a form acceptable to the Food and Drug Administration, the governing body over both human and animal drug approval. The FDA approval process is the most extensive law of its kind in any country. All regulations are focused on protecting the end user and providing a safe, effective product. In short, the FDA will not allow a company to market a drug as FDA-approved if it has not proven its effectiveness in multiple scientific studies.