House bill would speed approval once EU OKs same product
From left: Rep. Steve Stivers (R-OH) and Rep. Tim Ryan (D-OH)
Rep. Steve Stivers (R-OH) has introduced the Speeding Access to Already Approved Pharmaceuticals Act of 2014, which would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union (EU). The bill is cosponsored by Rep. Tim Ryan (D-OH).
“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 says in a statement.
“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 bill would require FDA to facilitate the development and expedite the review of a drug within 90 days after the EU approves a pharmaceutical product.