Generic Drugs are Just as Effective

n a previous issue of Bovine Health Watch we published an article discussing generic pharmaceuticals, the approval process, and how they compare in potency and effectiveness. But with the current economic environment, and the investment you make for these products, our editors believe it is important to once againmention the key points about generic products and the performance you can expect. Keeping these points in mindcould provide significant cost savings for your operation.

All human and animal drugs, generic drugs included, must complywith the Federal Food, Drug, and Cosmetics Act and Food and DrugAdministration (FDA) requirements and regulations. To market a generic animal drug, the company must obtain approval from FDA’s Center for Veterinary Medicine (CVM) by submitting an Abbreviated New Animal Drug Application (ANADA).

Before approval is granted, the generic product must be proven to be equivalent. That is, the drug must have the same active ingredient, same strength and dosage form as the pioneer product. The exception to this is if the generic sponsor files a suitability petition with CVM for a different dosage form and CVM approves the petition. The generic drug is also required to carry the same labeling, including warnings and safety information, as the pioneer drug. Of course, the trade dress for the generic product will be
different than the pioneer.

Here are some important points to remember regarding generic animal drugs:

• A generic drug is simply a copy of a pioneer product. There is nodifference in the requirements for manufacturing or active ingredientpotency. FDA requirements for generic drugs for strength, quality,
purity, and stability are the same as their pioneer counterparts.

• Generic products must be approved by the CVM, and they must demonstrate they will deliver the same amount of activeingredient to the site of the drug’s action as the pioneer product.

• Generic animal care products are just as safe as pioneer products.FDA requires that all animal care products be both safe and effective. Generic products contain the same active ingredients and work in an identical manner; they also provide the same benefits and carry the same risks as their brand-name products.

• Generic products are generally less expensive than those offeredby the original manufacturers. Preparing a new drug for market involves a large investment in research and development.

New products are developed under patent protection, providing thepioneer manufacturer the exclusive right to sell that product while the patent is in effect. Prior to patent expiration, a generic sponsor may submit an ANADA to sell a generic version. CVM can’t approve the ANADA until the pioneer patent has expired. Because the generic sponsors don’t have the same research and development costs, those savings can be passed along to you.

Recently, Congress passed the Animal Generic Drug User Fee Act(AGDUFA). Signed into law in the fall of 2008, AGDUFA was negotiated between CVM and the Generic Animal Drug Alliance (GADA) to reduce the average number of days for CVM to review an ANADA from 700 to 270 days. In effect for 5 years withreauthorization required in fiscal 2013, the law should expedite ANADA approvals and further benefit producers in their purchases of animal health products.

More information regarding generic animal products and their useis available on the GADA web site at www.gadaonline.org. In addition, please feel free to contact AgriLabs with any questions you may have about generic equivalent products. While many generic drug manufacturers do not provide technical service at a level equivalent to the pioneer manufacturers, AgriLabs has a staff of technical service veterinarians who are available to answer any questions AgriLabs’ customers may have.