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Senators Hassan, Braun Introduce Bipartisan Bill to Close Loophole Detailed in Recent NYT Report that Allows Big Pharma to Block Medication from Entering the Market

WASHINGTON – U.S. Senators Maggie Hassan (D-NH) and Mike Braun (R-IN), members of the Senate Health, Education, Labor, and Pensions Committee, reintroduced their bipartisan bill to close a loophole that Big Pharma can exploit to block competition from better alternative drugs, including generic drugs, and keep drug prices high. The reintroduction of the Senators’ Prescription Drug Competition Act follows a recent New York Times report revealing that Jazz Pharmaceuticals, a major drug company, used this loophole to block a competitor that was poised to release a better version of the drug.

The FDA often requires that drug manufacturers have a Risk Evaluation and Mitigation Strategy (REMS) program for potentially dangerous medications – for instance, requiring training for doctors to prescribe the drug. Some pharmaceutical companies patent their REMS program as a way to delay or block alternate versions of the medication from entering the market, in order to stop competition and keep prices high. As detailed in the recent New York Times report, Jazz Pharmaceuticals used this exact strategy of patenting their REMS program in order to slow down the release of a similar drug from their competitor that is easier for patients to take.

Senator Hassan and Braun’s bill enables the FDA to immediately approve drugs – instead of the normal 30-month approval stay – if the only barrier to approval is a REMS patent, such as in the case of Jazz Pharmaceuticals. In addition, their bill stops pharmaceutical companies from abusing the patent and court system by ensuring that if a drug company sues to stop a generic over a REMS patent, the lawsuit may go on, but it cannot stop the sale of the generic drug.

“Our bipartisan bill would finally close this absurd loophole that big pharmaceutical companies, such as Jazz, can use to slow down the release of better, cheaper drugs in order to line their own pockets,” Senator Hassan said. “For too long, Big Pharma has artificially inflated drug prices at the expense of patients, but it doesn’t need to be this way. I will continue working across the aisle to take on Big Pharma and lower health care costs for all Americans.”

“The more generic drugs that are able to be approved and make it to our pharmacies, the better for American patients. We need more competition in the prescription drug market to lower prices and get Americans a better deal,” Senator Braun said.

As a member of the Senate Health, Education, Labor, and Pensions Committee, Senator Hassan has led efforts to expand access to affordable health insurance and lower health care costs. Senator Hassan is working across the aisle to make cheaper generic drugs more available, including securing three bipartisan measures in the year-end funding bill, which is now law, to increase access to generic and biosimilar medications. Senator Hassan also led successful bipartisan efforts to help eliminate surprise medical billing, which has prevented at least 9 million surprise bills. Additionally, the Inflation Reduction Act included a number of key provisions that Senator Hassan pushed for to take on Big Pharma and address the skyrocketing cost of prescription drugs, including allowing Medicare to negotiate prescription drug prices – which will bring down the cost of prescription drugs for Medicare beneficiaries and help drive down prices across the board – and capping out-of-pocket expenses for Medicare prescription drugs.