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WASHINGTON, D.C. – Congressman Brett Guthrie (KY-02), Republican Leader of the Energy and Commerce Committee’s Health Subcommittee, and Congressman Kurt Schrader (OR-05), Health Subcommittee member, introduced the Protecting Access to Safe and Effective Medicines Act.

“Increasing competition for prescription drugs helps drive down costs for patients, and that’s what the Protecting Access to Safe and Effective Medicines Act would do,” said Guthrie. “By making a clarification on FDA drug applications, drug companies would no longer be able to game the system and patients will ultimately be able to choose cheaper drug alternatives. I’m pleased to support this bipartisan solution to lower what patients pay for prescription drugs.”

“I am proud to be leading an effort that will encourage the development of innovative medicines. The bipartisan Protecting Access to Safe and Effective Medicines Act is an important measure that will streamline the FDA’s ability to determine exclusivity, prevent gaming, and allow generic drugs to come to market faster,” said Schrader. “While a complicated issue, the need for more low-cost drugs is not and I will continue to work on measures to address this nonpartisan issue on a bipartisan basis.”

This bill would lower drug costs by making a change in FDA drug applications to narrow what drugs can receive market exclusivity. When an innovative drug is successfully developed, market exclusivity is awarded for taking risks and putting an investment into the creation of the treatment or cure. After the market exclusivity period expires, generic alternatives of the drug can come to market. Replacing “active ingredient’ with “active moiety” on FDA drug applications prevents drug companies from creating a chemical derivative of an existing drug to claim market exclusivity in order to keep cheaper alternatives of the drug out of the marketplace.

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