Legislation calls for European-approved drugs to be available more quickly in U.S.

The Speeding Access to Already Approved Pharmaceutical Act, sponsored by Reps. Steve Stivers (R-OH) and Tim Ryan (D-OH), would require FDA to expedite the review and approval of pharmaceutical products already approved in Europe.

The Speeding Access to Already Approved Pharmaceutical Act, sponsored by Reps. Steve Stivers (R-OH) and Tim Ryan (D-OH), would require FDA to expedite the review and approval of pharmaceutical products already approved in Europe. While FDA approves between 66% and 74% of drugs before anywhere else in the world, a handful of drugs are approved elsewhere—including Europe—first. The legislation introduced this month by Stivers and Ryan would enable FDA to rely more heavily on EMA when regulating products. The measure would accelerate the review process by requiring FDA to review any drug approved for use in the EU in just 90 days—far more quickly than FDA's current fastest assessment, which takes 6 months (priority review designation). The accelerated review would need to be made at the request of a drug's sponsor, the bill states.