Representatives Ryan and Stivers Introduce Legislation to Get Medication to Patients in Need Sooner

Jun 23, 2014 Issues: Health Care

WASHINGTON D.C. – Congressman Tim Ryan (D – OH) and Congressman Steve Stivers (R – OH) today introduced the Speeding Access to Already Approved Pharmaceuticals Act of 2014.  The bill requires the Food and Drug Administration (FDA) to expedite the review of pharmaceuticals that are approved by the European Union (EU). 

“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,” Stivers said.   “These delays result in unnecessary death and suffering of American patients. 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 saving lives and improving the quality of life for millions of Americans who need 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.

“There are too many examples around the country of illness outbreaks that can be successfully treated with medications that have been approved by the EU and are delayed in the FDA approval process,” said Congressman Tim Ryan. “This legislation is a step in the right direction in improving access to safe and properly tested medication for the millions of Americans who are in need.”

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.