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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26 FEED•LOT September/October 2018 need to conduct studies to get this information. For any studies that are performed, the sponsor analyzes the results. • Based on the collected informa- tion, including any study results, the sponsor decides if there is enough proof that the drug is safe and effective to meet the requirements for approval. • The sponsor submits a New An- imal Drug Application (NADA) to CVM. The NADA includes all the information about the drug and the proposed label. • A team of CVM personnel, in- cluding veterinarians, animal scientists, biostatisticians, chemists, microbiologists, phar- macologists, and toxicologists, reviews the NADA. If the center's team agrees with the sponsor's conclusion that the drug is safe and effective if it is used accord- ing to the proposed label, CVM approves the NADA and the drug sponsor can legally sell the drug. FDA gives "marketing exclusiv- ity" to a drug company that gets a brand name animal drug approved. Starting on the date of approval, marketing exclusivity is the time period during which FDA will not approve a generic copy of the ap- proved brand name animal drug. The marketing exclusivity lasts for five years for a first-time approval Today's producer has a wide range of pharmaceutical products available to prevent disease, treat disease, control parasites, regulate estrus and so much more. Products range in price from less than a dollar per head to $30 or more per treatment. Some products are fairly new on the market while others are decades old. Regardless, all pharmaceuticals are regulated by the FDA's Center for Veterinary Medicine (CVM), and the process to bring products to the marketplace is a very expensive one. Bringing a pharmaceutical to market is a time-consuming, ex- pensive, and scientifically rigorous process. Companies must demon- strate that the pharmaceutical is safe and effective in animals. According to the Animal Health Institute (AHI), the development of a major new animal drug takes seven to 10 years and can cost up to $100 Million. Pioneer Product To eventually reach the store shelves, a pioneer product goes through the following steps, ac- cording to the FDA. • The drug sponsor (typically a pharmaceutical company) col- lects information about the safe- ty and effectiveness of a new animal drug. The sponsor may PIONEER AND GENERIC PRODUCTS UNDERGO STRICT PROCESSES TO REACH THE MARKETPLACE Graphs are from the Animal Health Institute. 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 $8 Billion $7 Billion $6 Billion $5 Billion $4 Billion $3 Billion $2 Billion $1 Billion $0 Animal Medicines Sales – Ten Years of Progress Vaccine Sales Pharmaceutical Sales ROAD TO APPROVAL INDUSTRY & INNOVATION BY JILL J. DUNKEL

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