As FDASIA Celebrates First Year, FDA Says Drugs, Devices Already Seeing Benefit

On 9 July 2012, US President Barack Obama quietly signed into law a piece of legislation that had received overwhelming support in both chambers of Congress - a relative rarity in the hyper-political 112^th Congress. That law, the Food and Drug Administration Safety and Innovation Act (FDASIA), is now one year old, and the US Food and Drug Administration (FDA) is marking the occasion by talking about what it's been doing to implement the considerable number of provisions the law contains.

Background

FDASIA, like many FDA-centric laws passed before it, is a combination of two main elements: user fee reauthorization measures and general reforms. In the case of FDASIA, legislators passed reauthorization bills enhancing rates for medical device and pharmaceutical user fees, while enacting new user fee provisions for generic and biosimilar drugs as well.

The legislation also contained a massive number of general reforms, calling for reports to be developed, guidance documents to issued, infrastructure created and new authorities used.

Hamburg: FDA Performance Improving as Result of FDASIA

In a post on the FDA Voice blog, FDA Commissioner Margaret Hamburg explained that much of the agency's efforts have been focused on implementing the provisions of the Generic Drug User Fee Act, contained within FDASIA. The measure is meant to give FDA the resources to inspect generic drug manufacturing facilities, which are increasingly located abroad, requiring more agency resources relative to domestic facilities.

And in one respect, FDA says the program has already had a several major successes. Hamburg wrote that the program has already reduced a once-massive backlog of generic drug applications, enhanced the efficiency with which FDA reviews generic drug applications, and streamlined its hiring processes.

On the medical device front, Hamburg said the Medical Device User Fee Act has succeeded in expediting "the availability of innovative new products to market and the program has already seen a decrease in the application backlog for device submissions." No specific data was cited to back up either claim, however, so the size of the effect is unknown.

General Achievements

More generally, Hamburg also noted meeting a number of other FDASIA milestones, including the launch of the much-discussed breakthrough product designation, a new Patient-Focused Drug Development Program that has already held several disease-focused meetings, and being able to detain drugs using newfound authority.

In addition, FDA also revealed that it sought and obtained heightened penalties from the US Sentencing Commission for drug counterfeiting. It is unclear whether this activity was directly as a result of FDASIA, or simply prompted by similar provisions within the law.

Calling the implementation of FDASIA a "massive undertaking, Hamburg said FDA is "committed to implementing the requirements of FDASIA in a way that provides lasting improvements to public health, and we will meet these objectives as quickly as resources allow."

FDA Voice Blog

FDASIA Portal