Posted 29 April 2013
By Alexander Gaffney, RF News Editor
The US Food and Drug Administration (FDA) has awarded a massive new contract to contractor International Business Machines (IBM) to help the agency improve its ability to review and analyze regulatory submissions the agency receives from pharmaceutical, medical device and biologic manufacturers.
FDA first published a request for a proposal in July 2012, explaining that it was "seeking strategic and operational planning and other technical and user support, to ensure the most effective, efficient, sustainable and otherwise successful implementation and operation for business informatics to support regulatory review goals."
"The development of this core infrastructure for the FDA reviewer community will create the foundation to better support a number of ongoing efforts in pre-market development, modernization of product review, post-market safety (includes adverse event reporting and recalls), and product quality," FDA added.
The impetus behind the initiative is the FDA Safety and Innovation Act (FDASIA), which contains several user fee provisions that fund regulatory science and infrastructure improvements at the agency, which industry hopes will improve the efficiency of application reviews.
FDA explains in its original request for proposal (RFP) document that it agrees with that sentiment, saying improvements would allow it to more thoroughly review and analyze applications, interact more with sponsors and their review teams, be more transparent, improve decision-making, improve their communication with industry, and address "late-emerging issues more effectively."
"With the new capabilities and tools over the next 10 years, efforts required to complete review work in FDA Centers could be reallocated to enhance productivity and value. These new capabilities will allow increased time to conduct more in-depth analysis of safety issues as well as improve tool sharing among reviewers across the FDA with the ultimate goal of increased process efficiency, quality and transparency in decision making, providing greater insight into the most successful approaches to both pre-market development review and post-market risk management."
$75 Million for Regulatory Overhaul
And FDA is preparing to put a considerable amount of money behind its contracting effort, awarding a five-year $75 million contract to IBM meant to sustain a drive to improve its computational science capabilities.
One of the more interesting aspects of the RFP is that it calls for the contractor to "drive change"-regulatory change-at the agency, including developing and implementing "needed data standards" meant to increase electronic submissions and facilitate access to electronic data and reviews.
The ultimate goal, FDA says, is to have an "end-to-end process" that allows FDA to not just have access to the data submitted by industry, but also the tools necessary to analyze it throughout the product's lifecycle-a "suite of analytics to efficiently answer targeted regulatory review questions," FDA stipulates.
The first FDA center to benefit from these changes will be its Center for Drug Evaluation and Research (CDER). That decision was made easier by CDER's Computational Science Center, which is reportedly already well along in its own process of starting up an electronic "Regulatory Review Environment."
"Once completed, this environment … will allow the CSC to realize its vision of supporting CDER decisions by high-quality quantitative analysis of current and prior information regarding efficacy, safety and products quality over the product lifecycle," FDA explained.
IBM's 60-month award period ends on 26 April 2018.
FDA: Regulatory Review Support