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 The leading web portal for pharmacy resources, news, education and careers December 15, 2018
Pharmacy Choice - Pharmaceutical News - AFIA Applauds Passage of Bill to Improve Federal Process for Approving New Animal Drugs and Animal Food Ingredients - December 15, 2018

Pharmacy News Article

 8/3/18 - AFIA Applauds Passage of Bill to Improve Federal Process for Approving New Animal Drugs and Animal Food Ingredients

ARLINGTON, Virginia, Aug. 2 The American Feed Industry Association issued the following news release:

The American Feed Industry Association commends Congress for sending a bill to the president this week for signature - the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (H.R. 5554). This bipartisan legislation will continue providing the necessary resources to support the Food and Drug Administration's Center for Veterinary Medicine with completing more expeditious reviews of new animal drugs and improving FDA's review and approval process for animal food ingredients.

"For the past several years, AFIA has voiced its members' concerns to the FDA over the antiquated system for approving new animal food ingredients to be used in feed and pet food," said AFIA's President and CEO Joel G. Newman. "While other countries have moved forward with safe ingredients that will enhance the safety, quality and nutrition of feed and pet food, our U.S. animal food ingredient manufacturers have been trapped in the lengthy and costly web at the FDA. We are encouraged that Congress has recognized the need for the U.S. animal food industry to have greater access to novel ingredients and drugs to improve animal health and wellbeing, while reducing costs for ingredient manufacturers so they can continue investing in much-needed research and development, and urge the president to quickly sign this bill."

In recent years, the review and approval process at the FDA has slowed dramatically, preventing new animal food ingredients from reaching the marketplace. A recent study by Informa Economics, on behalf of the Institute for Feed Education and Research, found that for every year of delay in the approval process, submitting companies across the animal food industry were losing an average $1.75 million in revenue. Review times have increased in recent years, now averaging anywhere from three-to-five or more years. In addition, as the regulatory requirements to achieve these approvals have increased, companies have been forced to hire additional staff to decipher the legal language and complete all the necessary paperwork to usher ingredients through the process.

The bill includes language that would streamline the FDA's process for approving new animal food ingredients, reducing the burden on both the agency staff and the regulated industry without compromising animal food safety. It would also require the FDA to provide guidance to submitting companies regarding how the data should be formatted and the scientific rationale when the agency requests more data or time to review submissions.

In addition, the law strikes an unnecessary provision in the Food and Drug Administration Amendments Act of 2007 that previously required the FDA to establish ingredient standards and definitions for pet food, which the agency sought to expand to all animal food. This provision is duplicative with the review process that has been in place at the Association of American Feed Control Officials for years, whereby the association sets definitions for all ingredients used in animal feed and pet food in its annual Official Publication, the legal listing by which states abide for the commercial sale of animal food products. In making this change, it ensures that the hundreds of safe ingredients that have been used in feed and pet food since the 1960s are still available in the marketplace.



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