At the end of October, the U.S. Food and Drug Administration (FDA) announced it is seeking feedback to improve communication with the agency during the clinical trials process. The announcement, posted on the Federal Register, notes the agency opened a docket to allow for comments from interested parties such as regulated industry and academic institutions on practices for communication between FDA and investigational new drug application (IND) sponsors during drug development. From these comments, FDA hopes to identify and establish best practices to be included in the new draft guidance. Ideally, improved communication will ultimately afford industry more time to spend investigating new drugs instead of clearing administrative hurdles.
The Guidance
In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). The legislation authorized FDA to begin collecting fees from drug sponsors that would be utilized to expand review staff, and thus review drugs in a more efficient manner. The Act has been periodically reviewed and expanded through reauthorizations. Under the fifth authorization of PDUFDA, FDA is to publish guidance for industry and review staff describing best practices for communication between the agency and IND sponsors during drug development.
The FDA specifically cites promoting innovation as one of the major benefits of an enhanced collaboration between government and industry during communications related to clinical trials. This will be especially important, as FDA has noted in previous guidances, over the past two decades the number and complexity of clinical trials have grown dramatically. These changes create new challenges to clinical trial oversight, of which communication with industry is one.
FDA offers a preview of the guidance, noting that the document will describe FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity and the scope of appropriate interactions between the review team and the sponsor, and outline the types of advice that are appropriate for sponsors to seek from FDA in pursuing their drug development program.
Additionally, the guidance will describe the general expectations for the timing of FDA response to IND sponsor inquiries of simple and clarifying questions or referral of more complex questions to the formal meeting process, and describe best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor during drug development.
The guidance will also emphasize its expectations on appropriate methods of communication. This may mean examples where teleconferencing should be used, or alternatively, when secure email may be more appropriate to communicate with FDA. We will keep an eye out for this guidance and publish more information as it becomes available.
Comments
In the meantime, if you are interested in sending FDA a comment, you may do so electronically at http://www.regulations.gov or provide written comments to the Division of Dockets Management [Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852]. It is only necessary to send one set of comments. Identify comments with the docket number FDA-2014-N-1575.
Comments are due by December 29, 2014.