Stivers reintroduces bill expediting FDA review of drugs already approved by EU

The U.S. Food and Drug Administration would be directed to expedite review of pharmaceuticals that are already approved for use in the European Union (EU) under bipartisan legislation reintroduced by U.S. Rep. Steve Stivers (R-OH).

The Speeding Access to Already Approved Pharmaceuticals Act would amend the Federal Food, Drug and Cosmetic Act to require the FDA commissioner to develop a process to review new drugs, biological products or medical devices within 90 days of EU approval.

“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.”

Under current processes, it can take more than a decade for pharmaceuticals to gain FDA approval. The FDA, for example, continues to review new sunscreen ingredients that eight companies have submitted since 2002.

Stivers and U.S. Rep. Tim Ryan (D-OH) reintroduced the legislation on Thursday.