Political Quotes

“in February, the HELP Committee passed a bill to reauthorize the animal drug and animal generic drug user fee programs at FDA. That bill was the result of months of bipartisan work. During markup, we worked together to put aside differences and adopted an amendment from Senator Murphy increasing innovation in animal drug trial designs to advance more medicines for our pets and livestock-- similar to the work we did for humans in the 21st Century Cures Act-- and an amendment from Senator Paul to clarify the regulatory process for animal feed additives. We worked together because this bill has to pass by August 1 to avoid disruption to the hard-working employees at FDA who ensure our pets and food-producing animals have safe and effective drugs. Last month, the House Energy and Commerce Committee took our bipartisan bill that we worked on together and added a controversial amendment that expands the conditional approval pathway for animal drugs. Currently, the FDA can conditionally approve an animal drug for a minor species or for an uncommon disease in a major species. This narrow category of drugs can be approved, for a limited time, and sold to customers while the company collects data to determine whether the drug actually works. This pathway was supposed to spur innovation, but only four drugs have ever been conditionally approved in the pathway's 14-year history, and only one of those four was actually effective and gained full approval.…”