The Manual of Policies and Procedures (MaPP) 4520.1 entitled Communicating Drug Approval Information, underwent revisions and the new revised MaPP was published today. While it’s current revision history notes the following change – “Decreased the time for webmaster to post change from three to two business days, for approved labeling for drug approvals”, everyone interested in FDA product approval should become familiar with the contents of this MaPP last revised in 2014. Just as a reminder the MaPP documents describe internal CDER policy and procedures.
FDA acknowledges that “both inside and outside of FDA. FDA district offices, the trade press, the pharmaceutical industry, individual practitioners, patients, and international FDA counterparts are interested in this information. When an application is approved, FDA makes the information available according to the priorities and time periods specified in this MAPP.” While we see much more information published quickly on NDA and BLA approvals, especially for new molecular entities or new indications, the document explains how the FDA priorities are designated for each type of application including ANDA approvals. This also explains why it takes a few days for approval information to published on the CDER web site.
In addition, it is noted that while the existence of ANDA approvals (AP) and tentative approvals (TA) should appear with basic information on the CDER web site, that AP and TA letters will appear at Office of Generic Drug (OGD) discretion (usually first time ANDA approvals or where the ANDA will be the designated reference listed drug). This has been a bone of contention from the industry as the only accurate method of tracking length of time to approval is from the dates of ANDA receipt that are published in the approval letters. Having access to only those ANDA approval letters designated by OGD for publication leaves the vast majority of approval letters unavailable shortly after approval and usually requires those in industry interested in such information to file an FOI request. While we understand that the volume of work OGD has makes this additional information difficult to process, it would certainly be a welcome addition to the information available on approved ANDAs.
The MaPP provides timelines for action relative to publication of approval information, identifies the responsibilities of each component of CDER and provides a list of definitions of terms used in the document. It is good reading and a god reminder of how the process works. A complete copy of the MaPP can be found here.