This year has been one of the most critical years for FDA reforms, from the Prescription Drug User Fee Act (PDUFA) and the FDA’s approval of more lower-cost generics, to expedited approval pathways for new drugs and biosimilars. The outcome of these reforms will mostly likely determine which path the FDA will take in shaping the future regulatory environment to support both the industry’s innovation while providing adequate safety and public health.
Last year, approximately 78% of the over 3 billion new and refilled prescriptions dispensed in the US were filled with generics (1).
In fact, over the last decade, generic drugs have provided significant savings to the nation’s healthcare system. However, for various reasons, there have been significant regulatory challenges. For example, in contrast to the brand manufacturers who pay fees under the PDUFA, the generic industry does not pay a user fee to the FDA. With the drastic increase in applications for generic products, the FDA has had great difficulty keeping up. This in turn has caused the approval time for generic applications to double.
Since today the majority of generics are manufactured outside of the US, the FDA has faced the additional challenge of geographic distance. As a result, the FDA must conduct primarily foreign inspections which require a significant amount of resources. This is particularly challenging since India and China are exhibiting the most significant countries responsible for the production of generics. Identifying the manufacturing facilities responsible for producing components and finished products, as well as ensuring that all facilities comply with FDA regulations will be of primary focus in the coming year. A new Generic Drug User Fee Act (GDUFA) has also been proposed for 2013 to help address some of these issues.
Biosimilars have also posed a serious challenge for the FDA, as approval pathways have had to be reconsidered and restructured. The Biologics Price Competition and Innovation Act (BPCI Act) of 2009, also part of the Affordable Care Act of 2010, shortened the approval pathway for biologics that were established as “interchangeable with” an FDA-approved biologic. The current pathway is on the road to better balancing safety with timeliness. A new biologics user fee program has been proposed for 2013 which, like the PDUFA, includes fees for marketing applications, etc.
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