Roberts’ provision to hasten new animal drugs to market set to become federal law

A provision sponsored by U.S. Senate Agriculture, Nutrition, and Forestry Committee Chairman Pat Roberts (R-KS) to more quickly put new animal drugs in the hands of veterinarians via conditional approval by the U.S. Food and Drug Administration (FDA) is on the president’s desk waiting to become law.

Sen. Roberts’ provision is included in the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, H.R. 5554. The U.S. House amended and approved H.R. 5554 on July 16, followed by U.S. Senate approval on July 31. The Senate on Aug. 3 presented H.R. 5554 to President Donald Trump for his signature.

“Given the numerous accelerated pathways on the human drug side of the agency, it is commonsense to allow additional flexibilities for FDA to review, approve and provide access to innovative therapies for our animals – both food producing and companion,” said Sen. Roberts, a senior member on the U.S. Senate Health, Education, Labor and Pensions Committee, which has FDA oversight.

Additionally, under current law, an FDA drug made available by conditional approval may be used to treat 310,000 cattle and 70,000 dogs, according to an Aug. 1 statement released by the senator’s staff, which cited those limits as arbitrary. Section 304 under H.R. 5554 would modify such regulations.

“I am pleased we were able to broaden the eligibility for the conditional approval pathway to major species for innovative products and new indications,” Sen. Roberts said. “We do not change the FDA’s gold standard of approval for safety, we simply change the sequencing of the efficacy evaluations.”

The bipartisan H.R. 5554 was introduced on April 18 by U.S. Reps. Markwayne Mullin (R-OK), Greg Walden (R-OR), Michael Burgess (R-TX), and Rep. Kurt Schrader (D-OR) along with two other Democrats. It is the House version of the same-named S. 2434, introduced on Feb. 15 by U.S. Sen. Lamar Alexander (R-TN).