WASHINGTON – U.S. Senators Maggie Hassan (D-NH) and Josh Hawley (R-MO) introduced bipartisan legislation to lower prescription drug costs by closing oversight gaps that drug manufacturers take advantage of to prevent lower-cost competition. 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 the length of time during which the new drug is protected from competition, known as the exclusivity period, thus delaying the availability of lower-cost alternatives. The Medication Affordability and Patent Integrity Act 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 to have the FDA and USPTO start coordinating to stop patent abuses and allow for more drug competition, lowering costs for patients. Drug prices drop by as much as 20 percent when the first generic competitor to a drug enters the market and as much as 85 percent when multiple generics enter the market.
“For too long, Big Pharma has been abusing the patent process to block generic competition and keep prices for patients artificially high,” said Senator Hassan. “Granite Staters deserve better than a system that allows Big Pharma to exploit our patent system at the expense of families struggling to afford their medications. This bipartisan bill would help close a key loophole and bring down prescription drug costs for families across New Hampshire and the country.”
“Big Pharma companies have been driving up their profits by gatekeeping select drug information and exploiting our bloated bureaucracy. But their habit of gaming the U.S. patent system means delaying Americans’ access to affordable medications. This bipartisan legislation would require manufacturers to disclose critical drug information across agencies, so Congress can finally begin to upend Big Pharma’s anticompetitive practices,” said Senator Hawley.
Senator Hassan is working to lower prescription drug costs for Americans. Senator Hassan helped pass into law three bipartisan measures to increase access to generic and biosimilar medications. 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. Senator Hassan also led successful bipartisan efforts to help eliminate surprise medical billing, which has prevented millions of surprise bills.
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