Shaheen, Cassidy, Baldwin Introduce Bill to Close Orphan Drug Loophole
(Washington, DC) – U.S. Senator Jeanne Shaheen (D-NH) introduced bipartisan legislation with Senators Bill Cassidy, M.D. (R-LA) and Tammy Baldwin (D-WI) to close the orphan drug loophole that drug companies use to keep competition off the market and rake in profits.
“Health care costs were going through the roof before the pandemic, which is why as this crisis continues, Congress needs to do everything in its power to ensure Americans don’t sacrifice their personal health because they can’t afford it. Lawmakers should start by curbing skyrocketing prescription drug prices,” said Shaheen. “Our bipartisan legislation would do just that by cracking down on drug manufacturers who abuse the system to prevent more affordable competitors from coming to market. Unfortunately, we have seen drug companies game this system to charge sky-high prices for medications used to treat those who struggle with substance use disorder. As our communities suffer from the effects of how one public health crisis is exacerbating another, we need to be doing everything we can to ensure patients and treatment providers have access to affordable, effective medication. 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.”
“Health care monopolies lead to expensive – and often unaffordable – drugs. Eliminating the orphan drug loophole lowers prices by fostering market competition. Drug companies should have the ability to innovate, but that innovation cannot be the result of exploiting the market,” said Cassidy.
“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 Baldwin. “This legislation will close a loophole to help expand access to innovative medications. I’m proud to support this bipartisan effort to help fight this epidemic and save lives.”
Drug companies can get seven years of market exclusivity if they prove 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.
Shaheen has led efforts in Congress to stop drug manufacturers from abusing the FDA’s “Orphan Drug Designation” process in their attempt to limit market competition. She successfully petitioned the FDA to stop a manufacturer of medication to treat opioid-related substance use disorders from abusing this loophole. The FDA’s action against this manufacturer followed Senator Shaheen’s letter to the FDA and allowed potentially cheaper competitor drugs for the monthly injection version of buprenorphine, known as Sublocade, to come to market faster, which can help reduce the cost of the medication.
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