FDA Launches FDASIA Transparency Effort

Posted 28 November 2012 | By

The US Food and Drug Administration (FDA) is making it a whole lot easier to keep track of the agency's planned activities and projects coming out of the FDA Safety and Innovation Act (FDASIA), a massive piece of healthcare legislation that directs the agency to make changes to many of its pharmaceutical, medical device and biotechnology regulatory processes.

FDASIA is principally made up of four parts affecting prescription drugs, medical devices, generic drugs and biosimilar products. Each of those parts has a unique set of requirements, user fees, regulations and planned improvements to FDA. Of particular importance to industry are the timelines by which FDA is directed to issue certain guidance documents, regulations and strategic plans.

"The successful implementation of FDASIA is one of our top priorities," FDA's Malcolm Bertoni and Leslie Kux explained in a posting on FDA's blog. "To ensure its success, FDA set up a steering committee shortly after the law was passed to oversee the task of integrating the requirements of FDASIA into the agency's ongoing workload."

One of those integration projects has been the creation of a tracking system through which anyone can check on the progress of FDA's FDASIA implementation efforts.

Some of those deadlines are coming up fast. For instance, FDA is directed to issue a proposed regulation regarding pediatric information to be included in Humanitarian Device Exemption (HDE) applications and Premarket Approval Applications (PMAs) by 31 December 2012. That regulation has not yet been released.

Other deadlines have since come and gone without any FDA action. Section VI paragraph 611 directs FDA to, "Establish and publish in the Federal Register criteria to reaccredit or deny reaccreditation of third-party reviews." The standards were due by 6 November 2012, but FDA's tracking system shows no progress on the measure.

But accountability may well be the point of the system. The law's many statutory requirements-at least 93, starting in July 2012 and lasting until July 2017-would be difficult to track without a central system, and FDA has been panned in the past for blowing past statutory deadlines for certain regulations. For example, the unique device identification (UDI) system for tracking medical devices was mandated by the FDA Amendments Act of 2007, but is still working through a public comment phase as of November 2012.

For their part, Kux-who signs off on virtually every guidance document and regulation at the agency at assistant commissioner for policy-and Bertoni, assistant commissioner for planning, say the webpage will be updated on a "regular basis as part of our commitments to transparency about our FDAISA implementation."


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