Posted 17 April 2017
By Michael Mezher
A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.
The analysis was published in Cell Press earlier this month by Christopher Breder, a medical officer within FDA's Office of New Drugs and adjunct faculty at Johns Hopkins University's regulatory science program and two students in the program, Wenny Du and Adria Tyndall, RAC.
A TPP is a document that summarizes the key goals of a drug development program and is typically used to convey information the sponsor intends to include in a product's labeling or to detail critical manufacturing or quality attributes of a product.
In 2007, FDA issued guidance—still in draft form—detailing how sponsors can use TPP to facilitate efficient communication with the agency about a product's labeling information during drug development. The International Council on Harmonization (ICH) also recommends sponsors develop a quality target product profile (QTTP) as part of its guidelines on pharmaceutical development.
"Both the FDA and sponsors have seen the advantages of using a TPP at meetings early in the drug development process … A TPP helps focus a sponsor's drug development team and FDA review staff on the drug development goals in terms of drug labeling," FDA writes.
However, as the authors point out in an earlier analysis, TPPs are "vastly underused" based on a review of Summary Basis of Approvals (SBOAs) for drugs and biologics approved by FDA between 2008 and 2015.
Of the 808 approvals during that time, the authors found that only 87 (11%) referenced TPPs.
Compared to a control group of 353 applications from the same period, the authors found that submissions that included a TPP had a median approval time that was 30 days shorter than the control group (303 days versus 333 days).
"While the value of a 30-day difference may not be readily apparent, to a patient with a serious disease this difference can be critical. From a business perspective, the average monthly sales revenue from any one of the top ten drugs in terms of 2015 sales would constitute a significant proportion of the development costs of another development candidate," the authors write.
However, the authors are unable to determine exactly why these applications saw faster reviews, though they suggest that it may be due to "increased planning or because the TPP promotes well-organized regulatory dialogue."