Apr 17, 2024

Lawmakers Should Encourage FDA to Act Swiftly on Languishing Applications for Innovative Therapies During House Appropriations Hearing

(Washington, D.C.) — The Public Innovation Project (PIP) released the following statement ahead of U.S. Food and Drug Administration (FDA) Commissioner Robert Califf testifying before the U.S. House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration in a hearing titled, “Fiscal Year 2025 Budget Request For The Food And Drug Administration.”

“The hearing this week provides an opportunity for lawmakers and Commissioner Califf to discuss the lead role the FDA must play in fostering a prescription drug market that encourages true innovation, rather than gamesmanship and anti-competitive distortions that block access to new products,” said PIP executive director Joshua Lamel. “By challenging bogus patents, acting swiftly and judiciously on new applications, and opposing intimidation from anti-competitive pharmaceutical giants, the FDA can help level the playing field between true innovators and Big Pharma.”

“One timely example lawmakers could raise is the continued lack of final FDA action on an application from a small biotech, Liquidia Technologies, on an innovative dry powder inhaled form of Treprostinil – a drug used to treat pulmonary hypertension. Liquidia’s product completed a Phase 3 trial in 2018, but six years later, remains blocked from market entry by patent abuse and litigation from Big Pharma giant United Therapeutics Corporation (UTC) concerned with the prospect of new competition to their older products.”

“Earlier this year, after Liquidia successfully defeated all of UTC’s frivolous patent suits, UTC made one final effort to stop its would-be competitor from bringing their innovative new product to market by suing the FDA under the Administrative Procedures Act (APA to block approval of the small biotech’s application. A judge recently rejected UTC’s outrageous attempt to further game the system to block Liquidia’s approval for the new product.”

“It is incumbent on the agency to now act, one way or the other, or else risk establishing a troubling precedent that powerful, large drug companies can intimidate the FDA into slow-walking action on innovative therapies under the threat of litigation, no matter how frivolous, further extending monopoly and blocking market entry and competition.”

Learn more about the case of UTC and its anti-competitive strategy on Treprostinil HERE.

Find out more about PIP and our mission HERE.