Feed Lot

SEP-OCT 2018

Feedlots and cow/calf operations in the beef industry who feed 500 or more has annually on grains and concentrates; maintain 500 or more beef cows; backgrounder, stocker/grower, preconditioner; veterinarian, nutritionist, consultant

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FEED•LOT September/October 2018 27 drugs is whether CVM has deter- mined that veterinary oversight is required for the safe and effective use of the drug. If the center deter- mines that adequate "directions for use" can be written on the drug's label in such a way that a non-veter- inarian can use the drug safely and effectively, then it can be marketed as OTC. If not, then the drug must be marketed as either Rx or VFD. Both Rx and VFD drugs require veterinary oversight to be used safely and effectively. The main dif- ference between these two catego- ries of animal drugs is whether the drug is used in or on animal feed. According to AHI, member com- panies spent 10 to 12% of their sales investing in new innovations in ani- mal health. That investment is used to cover animal health innovations for the world's 24 billion chick- ens, more than 1 billion cattle and sheep, 750 million pigs and goats, 500 million dogs and 400 million cats. The time, care and investment put into the research and develop- ment of animal medicines ensures a steady stream of products that improve the health and well-being of animals. Considerable information for this article was obtained from the FDA. For addi- tional information on how pioneer and generic products reach the marketplace, visit www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ ComplianceEnforcement/Unapproved AnimalDrugs/ucm249392.htm. FL of an animal drug and three years for subsequent approvals of that drug. For example, the first time FDA approves a dewormer in hors - es, the drug company receives five years of marketing exclusivity. If FDA later approves that same dewormer for cows, the company receives three years of marketing exclusivity specific to the addition- al cattle claims. "Exclusive marketing rights" apply to designated brand name animal drugs for minor species or minor uses in a major species (called "MUMS drugs"). FDA gives seven years of exclusive marketing rights to a drug company that gets a brand name MUMS drug designated and then approved, or conditionally approved. This means FDA cannot approve a generic copy or another brand name version for seven years from the date of approval, or con- ditional approval, of the designated brand name MUMS drug. Generic Product After the patents and marketing exclusivity periods for an approved brand name animal drug have ex- pired, another drug sponsor can obtain approval for a generic copy. Generally, a generic drug sponsor will begin the registration process several years earlier. A generic animal drug goes through the Ab- breviated New Animal Drug Appli- cation process, which is different than the full approval process for the pioneer drug. The FDA requires a generic drug to have the same quality, perfor- mance, and intended uses as the brand name drug. Before marketing a generic animal drug, the drug company must prove to the FDA that the generic copy is the same as the approved brand name animal drug in: • Active ingredient; • Strength; • Dosage form; and • Dosage regimen, including route of administration. According to the FDA, the pro- cess is abbreviated because the sponsor doesn't have to conduct new safety and effectiveness stud- ies with the generic drug. Instead, the drug company must prove to the FDA that the generic copy is bioequivalent to the approved brand name drug. This means that the generic drug is absorbed by and performs the same way in the animal's body as the brand name drug. The FDA requires that the generic drug be manufactured un- der the same strict manufacturing standards as the brand name drug. The manufacturing processes for the generic drug must consistently produce a product that is equiv - alent to the brand name animal drug in identity, strength, purity, and quality. After approval, the quality and monitoring processes continue for the generic product, just as they do for the pioneer product. Those include reporting any manufactur- ing changes, ongoing stability test- ing, adverse event monitoring and submission of all advertising and promotional materials to the FDA. The science behind bringing products to the market is consid- erable and requires significant in- vestments. The approval process is the same for any new animal drug, whether it's an over-the-counter (OTC), prescription (Rx), or vet- erinary feed directive (VFD) drug. All must go through the NADA pro- cess, but one difference between these three categories of animal 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 $800,000 $700,000 $600,000 $500,000 $400,000 $300,000 $200,000 $100,000 $0 Animal Medicines – Investments in Research and Development In Millions

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