Schrader, Guthrie Bipartisan Solution to Lower Drug Costs Signed Into Law

Statement

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), each released a statement after their bipartisan solution to help lower drug costs was signed into law.

Schrader and Guthrie introduced the Protecting Access to Safe and Effective Medicines Act in the U.S. House of Representatives. The Senate companion of the bill was signed into law by President Joe Biden.

"S.415 passed in Congress with wide-ranging support before the President signed the measure into law, further showing policies to lower drug prices are both bipartisan and bicameral," Rep. Schrader said. "Congressman Guthrie and I partnered together to introduce the same policy in the House companion bill, the Protecting Access to Safe and Effective Medicines Act. I am proud our efforts will lead to lower drug prices for patients, simply by closing another loophole to prevent drug companies from gaming the system and holding back competition in the marketplace. Congress must continue to build off this momentum and pass other bills addressing the rising costs of lifesaving drugs."

"I'm thrilled that this bipartisan bill I introduced with my colleague Representative Schrader to help lower drug costs is now law," said Rep. Guthrie."This marks the first of the bills I've introduced this year that has been signed into law by President Biden. I continue to be open to finding bipartisan areas of agreement and using my role as Republican Leader of the Energy and Commerce Committee's Health Subcommittee to get work done to improve health care and lower costs for patients."

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.

S.415, the Senate companion to the Protecting Access to Safe and Effective Medicines Act, was signed into law on April 23, 2021.

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