New DARRTS IT Platform Could Complicate FDA TransparencySeptember 22, 2009
By Kurt R. Karst –
Over the past several weeks there has been growing chatter about FDA’s Document Archiving, Reporting and Regulatory Tracking System (“DARRTS”) and how its implementation might affect generic drugs. DARRTS is a Center for Drug Evaluation and Research (“CDER”) information technology platform developed to replace many of CDER’s core tracking systems, including those for ANDAs. Earlier this year, FDA issued a Manual of Policies and Procedures (“MaPP”) – MaPP 6700.4 – on the use of DARRTS for systematically tracking post-market drug safety issues, which explains that “[u]ltimately, [DARRTS] will be the archival system of record for new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) . . . .” Another MaPP, issued in April 2009 – MaPP 5210.3 – discusses the use of DARRTS in the Office of Generic Drugs’ (“OGD’s”) documentation of bioequivalence study reviewer productivity.
As DARRTS implementation moves forward, we understand that it will be used to, among other things, drive ANDA review priority based on a points system. Point values may be assigned to an ANDA based on an overview of patent certifications and when an application may be eligible for final approval or tentative approval, as well as once a particular OGD review component (e.g., chemistry or bioequivalence) is completed. The greater the number of points, the higher the application moves in the review queue. The intent of using this new point system is reportedly to make more efficient use of OGD’s resources so that those applications that can or should be approved sooner than others will be prioritized over applications that might not be approved for several years (e.g., because an ANDA contains a Paragraph III Certification to a patent that expires in many years).
Another effect of DARRTS implementation will be to create a new application numbering system. For decades, FDA has used a numeric system that easily identifies an application as an NDA or ANDA. For example, applications with a 20,000 or 50,000 series number are NDAs, and applications with a 70,000 or 90,000 series number are ANDAs. Under DARRTS, however, all submissions will now be numbered sequentially beginning with 200,000 regardless of application type. This change was recently criticized in a docket submission from a former FDA official:
The usefulness of being able to identify the type of application ANDA or NDA from the application number cannot be overstated. This will no longer be possible unless this is reevaluated and changed by FDA. The IT folks at FDA should serve the programs and cater to program needs not the other way around. This is vital historical information and is very useful to industry to be able to quickly identify NDA or ANDA filings for planning, patent and other purposes. The transparency has now been lost on this issue.
There is still much that is unknown about how DARRTS will be rolled out in OGD. Perhaps FDA will explain these changes at an upcoming conference or in an announcement.