February 11, 2020

Cassidy, Shaheen, Baldwin Introduce Bill to Close Orphan Drug Loophole

WASHINGTON – U.S. Senators Bill Cassidy, M.D. (R-LA), Jeanne Shaheen (D-NH) and Tammy Baldwin (D-WI) introduced bipartisan legislation today to close the orphan drug loophole that drug companies use to keep competition off the market and rake in profits.

Drug companies can get seven years of market exclusivity if it proves to the Food and Drug Administration (FDA) a new drug would not be economically viable without that exclusivity. If granted, that exclusivity persists for seven years even if the drug becomes economically viable on its own. By maintaining exclusivity, drug companies can make billions in profit without market competition.

The senators’ bill closes the loophole. It allows the FDA to remove market exclusivity if the drug company cannot continue to prove that the drug would be economically unviable when facing competition. This will drive down the cost of drugs by encouraging market competition.

“Monopolies within the health care system drive drug prices up, making drugs unaffordable. Closing the orphan drug loophole will lower drug prices by encouraging market competition. Drug companies must have the means to innovate, but they should not be allowed to exploit the market,” said Dr. Cassidy

“Congress needs to do everything in its power to curb skyrocketing prescription prices, and that includes cracking down on drug manufacturers who abuse the system to prevent more affordable competitors from coming to market,” said Shaheen. “As our communities fight to turn the tide of the substance use disorder epidemic, we need to be doing everything we can to ensure patients and treatment providers have access to affordable, effective medication to respond to this crisis. I’ll continue to work across the aisle to reduce prescription drug costs and increase market competition among manufacturers so Granite Staters and Americans across the country don’t have to pick between affording their medication and paying the bills.”

“Washington needs to step up and be a stronger partner to communities fighting the substance abuse epidemic, and we need to make sure that all safe and affordable treatment options are available to patients. We can do this by taking on unfair practices and leveling the playing field so we can use every tool at our disposal to combat this public health crisis,” said Senator Baldwin. “This legislation will close a loophole to help expand access to innovative medications. I’m proud to join this bipartisan effort to fight this epidemic and save lives.”

Click here for the bill text.