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Rep. Stivers Reintroduces Legislation to Get Medication to Patients in Need Sooner

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Washington, April 20, 2017 | comments
Congressman Steve Stivers (R – OH) today reintroduced the Speeding Access to Already Approved Pharmaceuticals Act. The bill requires the Food and Drug Administration (FDA) to expedite the review of pharmaceuticals that are approved by the European Union (EU). Congressman Tim Ryan (D – OH) is the cosponsor of the bi-partisan legislation.
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WASHINGTON – Congressman Steve Stivers (R – OH) today reintroduced the Speeding Access to Already Approved Pharmaceuticals Act.  The bill requires the Food and Drug Administration (FDA) to expedite the review of pharmaceuticals that are approved by the European Union (EU). Congressman Tim Ryan (D – OH) is the cosponsor of the bi-partisan legislation.

“Unfortunately, the United States FDA’s red tape causes delays of up to several years in approval for life-saving and life-changing medical treatments that may already be approved in Europe,” Stivers said. “This bill will help speed U.S. approval of drugs and medical devices deemed safe and effective by European authorities. It ensures the safety of these drugs while improving the quality of life for millions of Americans who need access to all available cutting-edge medical treatments.”

Specifically, the legislation requires the FDA Commissioner to facilitate the development and expedite the review of a drug within 90 days of the European Union approving a pharmaceutical.

Currently, it can take more than a decade for a product to get approved by the FDA.  For example since 2002, eight companies have submitted new and innovative ingredients for sunscreen, but all are still languishing in the FDA’s approval process. 

There are only three FDA-approved sunscreen ingredients available in the U.S which effectively guard against the sun’s UVA rays. Europe, on the other hand, has approved seven sunscreen ingredients that help protect against these harmful UVA rays.

Representatives Stivers and Ryan have introduced this bill in both the 113th and 114th Congress.

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