Shaheen, Cassidy & Baldwin Introduce Bill to Lower Prescription Drug Costs by Closing “Orphan Drug Loophole”

February 11, 2020

(Washington, DC) – Today, U.S. Senators Jeanne Shaheen (D-NH), Bill Cassidy, M.D. (R-LA) and Tammy Baldwin (D-WI) introduced the Fairness in Orphan Drug Exclusivity Act, bipartisan legislation that would 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. 

“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.” 

To read the text of the bill, click here. 

Shaheen has worked to prevent drug manufacturers from abusing the drug approval process to limit market competition. Following reports that the manufacturer of buprenorphine, which is used to treat those suffering from opioid-related substance use disorder in medication-assisted treatment (MAT), was attempting to use the orphan drug approval process to secure an additional seven years of exclusivity and block potentially cheaper generic versions of the medication from appearing on the market, Shaheen sent a letter to the FDA calling on the agency to prevent the manufacturer from abusing the system. As a result of Shaheen’s actions, the FDA revoked buprenorphine’s orphan drug status.