In June 2014, U.S. Congressmen Steve Stivers and Tim Ryan of Ohio introduced the Speeding Access to Already Approved Pharmaceuticals Act, which is currently referred to the House Committee on Energy and Commerce. This Act would require FDA to begin reviewing new drugs within 90 days of approval in the European Union (EU) as part of an effort to reduce “delays in approval for life-saving and life-changing medical treatments.” Many industry representatives, however, have expressed some concerns.
Regulatory expert Matthew Weinberg, CEO of The Weinberg Group says, “there will be a massive number of unintended consequences.” Weinberg begins by explaining the differences between FDA and the European Medicines Agency (EMA). These differences include varying methods for determining the safety and efficacy of pharmaceuticals. As a result not all products are mutually approved by both agencies.
Weinberg then provides two significant examples of potential “unintended consequences.” First, Weinberg says that by forcing FDA into a 90-day review, the agency will most likely reject the product due to insufficient information, adding that “it’s not their job to get new drugs on the market as fast as possible; it’s their job to protect American lives.” The second issue is that pharmaceutical companies would choose to apply for approval in Europe rather than the U.S., and then force FDA into a 90-day review of the product, which is “unheard of in this country for good reason,” according to Weinberg.
To read Fiona Barry’s full article, click here.