How the FDA remedied the drug review process

How the FDA remedied the drug review process

As patents on popular drugs approach their expiration dates, manufacturers of generic pharmaceuticals  are lining up at the Food and Drug Administration to get their versions approved for market. Adding to the FDA’s drug review workload was the Generic Drug User Fee Act of 2012, which required reviews within 10 months by 2017. Already reviewing 20,000 submissions each month, the FDA was looking at a business and technology migraine if it didn’t invest in some new systems.

The Center for Drug Evaluation and Research (CDER) wanted a business and technology transformation that would improve data management, streamline the regulatory review process and deliver business intelligence capability. The agency’s transformation would involve moving from custom to commercial solutions and from single-use, project-specific solutions to scalable ones that have comprehensive strategic informatics capabilities. The FDA assembled a multidisciplinary team to write the prescription for a solution.

The result is the CDER Informatics Platform, which the agency describes as a flexible toolset of off-the-shelf software that can be configured to myriad business needs across regulatory operations. It brings together the policy, administrative, scientific and operational reviews across the generic drug application review process, and improves the quality, speed, predictability, completeness and transparency of review.

Built over 18 months and launched in October 2014, the platform gives scientists and medical officers one place to review drug applications through four main informatics capabilities, according to CDER's Tim Irvin:

  • Business-to-business exchange, which enables simplified, secure entry and processing of electronic submissions.
  • Integrated data management, which provides an authoritative source of master data for regulated products, data governance guidelines, synchronization of agency data and easy accommodation of regulatory changes.
  • Business process management, which enables collaboration and communication through work status transparency,  standardized and shareable toolsets and one central, enterprise-wide repository.
  • Business intelligence and publishing, which uses an integrated data warehouse that allows for querying, reporting and analysis.

CDER is the end result of a series of incremental technology projects. The first used Informatica’s Master Data Management solution to eliminate data silos. To enable report generation at multiple levels -- executive, manager and user -- CDER built a centralized data warehouse called Mercado on an Oracle database.

“The platform is supported by centralized data management to ensure accuracy and consistency,” Irvin said. “All data is kept in one place and can easily be accessed by all of CDER staff.”

To migrate data to the new platform, FDA used a typical extract, transform and load process as it decommissioned older applications, Irvin said. CDER used Informatica ETL for this process, and for analytics and reporting, Mercardo used Oracle OBIEE. CDER also deployed Apache Solr to enable a Google-like search capability, FDA said.

To manage the transactional parts of the application process, CDER tapped a Workfront task management tool, which provides a standard project management, task-based approach to the review process. Lastly, the agency used EMC Documentum to manage and store documents created during the application process.

So far the platform has helped more than 2,500 users manage the review of tens of thousands of submissions, Irvin said. Users can access it from within the FDA network and through a secure virtual-private network connection. A mobile application is under development.

Looking forward, Irvin said CDER plans to expand use of the platform to all regulatory work, but no timeline for that has been set.

About the Author

Stephanie Kanowitz is a freelance writer based in northern Virginia.

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