Senate Approves Roberts’ Efforts to Improve Access to New Drugs for Animals

Dan Dairy & Livestock, Industry News Release, Regulation

Senate Agriculture Committee Chairman Pat Roberts applauded Senate approval of legislation to speed access to new animal drugs for veterinarians.

senateThe provision by Roberts was approved earlier this week that would allow access to new animal drugs through conditional approval by the Food and Drug Administration. Roberts’ provision on conditional approval was included in the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 which reauthorizes the Food and Drug Administration’s animal drug and generic animal drug user fee agreements.

The House passed identical legislation last month, meaning the bill is headed to the President’s desk to be signed into law.

Roberts said in a statement that the legislation is “common sense,” allowing additional flexibilities for FDA to review, approve, and provide access to animal drugs.

At issue are arbitrary limits on the use of animal drugs and therapies with conditional approval. Under the status quo, a drug that is made available by conditional approval can only treat 310,000 cattle and only 70,000 dogs.

From the National Association of Farm Broadcasting News Service.