WASHINGTON – Congresswoman Annie Kuster (NH-02), alongside Senators Maggie Hassan (D-NH) and Mike Braun (R-IN) as well as Representative Diana Harshbarger (TN-01), introduced bipartisan, bicameral legislation to lower prescription drug costs by closing oversight gaps that drug manufacturers take advantage of.

Because of incomplete coordination between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), drug manufacturers are currently able to unfairly extend the exclusivity period for a drug by submitting partial information for their initial patent, in order to help secure subsequent patents down the road. This increases their period of exclusivity and delays the availability of lower-cost alternatives. The Medication Affordability and Patent Integrity Act, introduced today, would require manufacturers to certify that they have not made inconsistent statements to the two agencies, helping stop abuses of the patent system. This legislation builds on Senator Hassan’s successful efforts last year to have the FDA and USPTO start to coordinate with one another to stop patent abuses and allow for more drug competition, lowering costs for patients. Drug prices drop by as much as 20% when the first generic enters the market and as much as 85% when multiple generics enter the market.

“The organizations responsible for approving the safety and use of medications need all the information available to make smart, informed decisions about what drugs can come to market when,” said Congresswoman Kuster. “But, because of loopholes in the approval process, some drug manufacturers can take advantage of the system. That’s unacceptable. I’m proud to introduce this bipartisan, bicameral bill to help stop abuses of the patent system and bring safe, low-cost medications to patients.”

“Last year, we took on Big Pharma by giving Medicare the ability to negotiate for lower prescription drug prices. We must continue to stand up to these big corporations and help people afford the medications that they need,” said Senator Hassan. “I have worked to stop drug manufacturers from abusing the patent process just so they can delay access to generic medication, and this bipartisan legislation is an important step forward in that effort. I urge my colleagues to support this bill as I continue working to lower prescription drug costs for Granite Staters and all Americans.”

“For far too long pharmaceutical companies have taken advantage of the patent system to their benefit. This bill will improve the patent process by preventing drug manufacturers from prolonging their market exclusivity,” said Senator Braun.

“Americans shouldn’t have to pay more at the pharmacy counter because of unfair patent extensions that delay less expensive generics from coming to market,” said Congresswoman Diana Harshbarger. “I’m proud to join this effort introducing new legislation that will help target these anti-competitive practices and remove barriers to better ensure access to lower-cost alternatives.”

Senator Hassan is working to lower prescription drug costs for Americans. The most recent government funding bill, which is now law, included three bipartisan measures backed by Senator Hassan 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.

To read bill text, click here.

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