US pharmaceutical regulators have announced that they will continue a regulatory program that allows companies to invite officials from the Center for Drug Evaluation and Research (CDER) into their facilities to learn more about how the industry works.
Background: Site Tours Program
The program, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the Site Tours Program, has been in effect in various forms since 1999 when it was created by CDER's Training and Certification Subcommittee.
At its core, the program is intended to bolster FDA's internal training programs by allowing its regulators to see how the pharmaceutical industry operates in practice.
"The goals of the program are to provide firsthand exposure to the industry's drug development process, a venue for sharing information about regulatory project management (but not drug-specific information), and an opportunity for CDER's regulatory project managers to fulfill an industry site tour requirement as part of CDER's Regulatory Project Management Certification program," FDA explains in its Manual of Policies and Procedures (MAPP) on the topic.
These site tours are funded by FDA and done on a voluntary basis with the cooperation of pharmaceutical companies, with priority given to those companies whose facilities have not been toured in the last three years. Those companies should not have "outstanding actions" related to enforcement decisions or use fees, FDA noted, though they are not mandatory exclusionary criteria.
The inspections themselves typically last 2-3 days and are meant to be an in-depth look at manufacturing operations by 2-5 regulatory project managers, including senior-level managers. The site tours also feature "daily workshops … focusing on selective regulatory issues important to both CDER staff and industry."
"The primary objective of the daily workshops is to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms, and regulatory submission operations," FDA explained.
Regulators said the ultimate goal of the program is to increase the exposure of their project managers to the techniques and processes used by the industry in the hopes of allowing them to obtain a better understanding of how the industry works from within and regulates its products.
The site tours are not without risk. FDA's MAPP explains that before each site tour, the Office of Compliance "will screen companies for any compliance issues both during the initial site selection phase of the program and approximately 30 days before the date of the site tour." That could call additional unwanted attention to a site if it happens to suffer from compliance issues right before a planned inspection, to say nothing of the inherent risks of FDA officials observing the interior of a facility in depth.
It should, however, be noted that FDA's MAPP said that, "Neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but is meant rather to improve mutual understanding and to provide an avenue for open dialogue." This language does not preclude officials from reporting those problems to colleagues whose job is to perform those functions.
However, it can also be an opportunity for companies to explain the complexities of their manufacturing processes and how they operate, potentially heading off future issues by giving regulators a more nuanced understanding of how their manufacturing processes work. In theory, avoiding these misunderstandings could make for smoother site inspections or fewer questions during manufacturing change applications like prior approval supplements (PAS).
Program to Continue
FDA now says it wants to continue the program, and has called on members of the pharmaceutical industry to submit proposed agendas to FDA in the next two months. Based on the applications it receives, CDER will then select some of those facilities to participate in the Site Tour program.
Based on prior Federal Register notices, the program is likely to continue until February 2015, when FDA will have the option of continuing it once again.
Federal Register Notice