- Reps. Tim Ryan (D-OH) and Rep. Steve Stivers (R-OH) have introduced a bill dubbed the Speeding Access to Already Approved Pharmaceutical Act, RAPS' Alexander Gaffney reports.
- The bill seeks to address the "drug lag"—the time between when one product is approved in one regulatory market and when it is approved and marketed in other countries.
- Although drug lag continues to be a concern, it has gotten much better since the Prescription Drug User Fee Act (PDUFA) was passed in 1992. As of 2013, the FDA said that 74% of new drugs approved in 2013 were approved in the U.S. before other markets; however, there are still drugs that are approved in the E.U. before they are approved in the U.S.
There are groups, including the International Conference on Harmonisation, dedicated to syncing regulatory standards between agencies such as the FDA and the EMA. The two lawmakers contend that the FDA's "red tape" causes delays in approval that can have fatal consequences for some patients.
Though the new bill aims to expedite approval times, as RAPS points out, there are some areas that need clarification. For example, in Europe, a drug can be approved through a centralized or a decentralized, country-specific procedure. In addition, the actions of the drug manufacturer affect approval times. Sometimes, companies submit their product for review in multiple markets simultaneously, while in other cases, they submit in different regulatory markets at different times. Also, there are different regulatory requirements in different markets.
Though Stivers and Ryan are determined to expedite approval times, the good news is that there has already been significant improvement since the 1980s.