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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, praised passage of their bipartisan solution to help lower drug costs in the House of Representatives.

Guthrie and Schrader introduced the Protecting Access to Safe and Effective Medicines Act in the House, and yesterday the Senate companion of the bill passed in the House of Representatives. This bill now heads to the president’s desk to be signed into law.

“Rep. Schrader and I partnered together in the House on the Protecting Access to Safe and Effective Medicines Act to help prevent drug companies from gaming the system,” said Rep. Guthrie. “Although this bill would simply make a clarification to FDA drug applications, this clarification would help bring less expensive drug alternatives to the market and lower drug costs for patients. This bipartisan bill now heads to the president’s desk, and I hope it is quickly signed into law to help provide savings for patients.”

“The 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 Rep. Schrader. “The market exclusivity period may reward innovation, but when companies inappropriately obtain exclusivity, this leads to less competition, higher drug prices and in turn, greater healthcare costs overall. I am proud to help lead this bipartisan effort to close this loophole and encourage the development of innovative medicines because all Americans deserve access to affordable, lifesaving drugs.”

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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