Kurt's Work

Today, the House of Representatives passed S. 415, a bill which seeks to lower drug costs by making a change in U.S. Food and Drug Administration (FDA) drug applications to narrow what drugs can receive market exclusivity.

S. 415 is the companion bill to H.R. 1857, the Protecting Access to Safe and Effective Medicines Act, which was introduced by Congressman Kurt Schrader (OR-05), a member of the Energy and Commerce Committee’s Health Subcommittee, and Republican Ranking Member of the Subcommittee, Representative Brett Guthrie (KY-02).

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.

WATCH: Schrader speaks on closing loophole to lower drug costs

“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,” Rep. Schrader said. “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.”

“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.”

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