The U.S. Food and Drug Administration regulates the safety, efficacy, and quality of drugs in the United States. Manufacturers, processors, and packagers of drugs are required to comply with current good manufacturing practices (cGMPs). When FDA issues new regulations that affect cGMPs, FDA needs to examine the potential impact of the changes in the regulations on affected entities, and to do that FDA needs information on current drug manufacturing practices. Anticipating the need for new regulations affecting cGMPs, FDA turned to ERG to provide the baseline data it would need to examine the impacts of changes made by new regulations.
ERG developed a multimodal survey (mail and online) and then used it to survey a representative sample of close to 1,500 drug manufacturing, processing, and packaging facilities in the United States and other countries that manufacture drugs for sale in the United States. This approach enabled us to collect data from close to 500 facilities, which was a challenge, given the length of the survey (almost 120 questions) and the variety of facilities surveyed. ERG analyzed the data and provided FDA with detailed population-level estimates of current drug manufacturing practices. Going forward, the results of the survey will serve as a baseline to determine the incremental costs that facilities may incur in complying with any new regulations.