The impact of FDA regulation, a CRO's perspective on changes in the industry
The signing of the Tobacco Control Act (TCA) on June 22, 2009 caused far reaching and permanent changes to the regulation and testing of tobacco products in the US. These changes have been seen in all aspects of the industry including manufacturing, labeling, product development and also analytical testing. The TCA created a framework for tobacco product regulation however, did not include details on how products would be regulated. The TCA also outlines a clear timeline for regulatory milestones from the submission of Substantial Equivalence (SE) applications to the establishment of the list of harmful and potentially harmful compounds in tobacco products. The agency has failed to meet many of these milestones and in turn granted extensions or enforcement discretion to the industry. The agency has also been delayed in the publication of rules and guidance documents related to regulatory submissions. These delays have presented a broad range of challenges to the industry and also to the organizations that service the industry including contract research laboratories (CROs). CROs are integral to the agency and the industry since they provide analytical testing services required for submission of product application. Since the passage of the TCA, CROs have prepared to meet the requirements of the FDA, often by trying to anticipate the requirements. Changes in FDA guidance has resulted in excess capacity or unneeded capabilities in the CROs. This presentation will focus on how CROs have responded to the challenges related to the changing regulatory landscape with a focus on the impact of changes and delays in tobacco product regulation guidance from the FDA.