Westerman, Gallagher, Burchett, Braun Introduce Bicameral Prescription Drug Legislation
WASHINGTON – Today, U.S. Reps. Bruce Westerman (R-Ark.), Mike Gallagher (R-Wis.) and Tim Burchett (R-Tenn.) and U.S. Sen .Mike Braun (R-Ind.) introduced the bicameral Conditional Approval Act, which would establish a pathway in the United States Food and Drug Administration (FDA) to increase access and lower costs of prescription drugs.
“Americans face the highest prescription drug costs of any modernized country,” Westerman said. “This is unacceptable. Congress needs to enact legislation that lowers costs and gives patients access to new, innovative cures. This bill gives small pharmaceuticals and startup biotechnology companies the opportunity to bring their drugs to market faster, allowing them to compete against monopolistic pharmaceutical companies and giving patients access to lifesaving treatments. I’m grateful for my colleagues in both the House and Senate who have come together on this bill and will continue working with stakeholders to get a conditional approval pathway passed.”
“If we have the opportunity to improve patients’ access to potentially lifesaving medicine, we should do it,” Gallagher said. “This bill is a no brainer. It helps level the playing field for small pharmaceutical companies and expedites the process by which critical medicine hits the market. I look forward to working with my colleagues on both sides of the aisle to get this across the finish line, and hope we can all come together to find a solution on conditional approval pathways.”
“The cost of critical drugs relied upon by Americans needs to be lower, and the best way to do that is through innovative, free market solutions,” Burchett said. “Our country is home to some of the brightest folks when it comes to developing new medicines, but sometimes these medicines are backlogged in a bureaucratic, expensive FDA process that delays them from coming to market faster. I am proud to support this common sense bill that rolls back these burdensome FDA regulations and allows new life-saving medicines to reach consumers who desperately need them.”
“Patients with fatal diseases are fighting for their lives every day while real, meaningful, life-extending treatments sit on the shelf just beyond their reach,” Braun said. “For those who are so courageously battling terrible diseases, the least we can do is not stand in their way.”
The FDA refers to the clinical trial process for prescription drugs in phases, i.e. Phase I, II and III. Early clinical trials (Phases I and II) establish and confirm safety while providing a considerable amount of data, often enough to statistically predict successful confirmatory trials. Confirmatory trials (Phase III) further test effectiveness and are the last step to a drug entering the market for patients’ use under a New Drug Application or Biologics License Application approval.
However, Phase III trials are extremely time-consuming and expensive, in some cases costing billions of dollars. If the FDA determines a drug doesn’t meet its standards of safety or effectiveness, small pharmaceuticals attempting to bring innovative drugs to market and compete with large drug companies can go bankrupt during Phase III trials.
The Conditional Approval Act would allow pharmaceutical companies to petition the FDA for conditional approval if the drug has cleared early stage clinical trials, already having proven safety and showing significant evidence of effectiveness. The company could then sell their drug at a market acceptable rate, give patients access to innovative treatments and compete with large, monopolistic pharmaceuticals to lower consumer cost.
To read the full text of the Conditional Approval Act, click here.