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Drug Development Question? Here’s How to Communicate With the FDA!
Earlier this month FDA (CDER and CBER) issued a new draft guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development. Based on Camargo’s frequent communications with the Agency during product development, the guidance does not present any profound or significant changes in how they conduct and or prefer communicating with IND sponsors. Rather, it does a good job of summarizing what most of the review divisions already do, and provides sponsors with useful instructions on how to effectively get the information they need from FDA. And, to the extent that it creates consistent behavior across all reviewing divisions it would provide a good deal of clarity for regulated industry.
The stated purpose of the guidance is:
“… is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public.”
The guidance was assembled using input on best communication practices from across CDER and CBER as well as input from interested parties who responded to an October 29, 2014 request for comment published in the Federal Register (79 FR 64397). There is a good deal of emphasis on the benefits of effective communication for both FDA and IND sponsors, to achieve more efficient and robust drug development programs. The guidance also discusses timelines a good deal, but provides few if any specifics, pointing instead to the various statutes, regulations, guidances, MAPPS and other FDA documents which do provide the timeline expectations involved for various FDA responses and/or actions. Emphasis is placed on the role of the Regulatory Project Manager (RPM) as the lynchpin for communication between an IND sponsor and the Division. Beyond that, the general policy towards the timing of responses to industry inquires and requests might be best summed up as “We’re interested, we know it’s important to you, we’ll get back to you as soon as we can, but we have resource and priority constraints too, and we may be dealing with lots of things you’re unaware that are currently occupying us.” There are also a number of exhortations for industry to consult FDA websites and guidances for answers to their questions before contacting FDA, in fact a section (VII.I., Resources for Sponsors) is devoted to it. There are seven primary areas which FDA expects will be topics for communication:
Regulatory (e.g., plans for submission of proprietary name requests, plans to defer or waive specific studies, development plans with other FDA centers (e.g., the Center for Devices and Radiological Health) for combination products), applicability of an expedited program
Regarding the timing of responses to questions and issues, FDA points out that what may seem to be a simple question to the IND sponsor, amenable to a phone call or email, may be from an FDA perspective anything but simple, i.e., a complex question. Here, FDA emphasizes the importance of using Meeting Requests and official submissions to the IND as the appropriate mechanism for getting an answer to a question. Again, as far as specifics go regarding timing, the guidance refers the reader to the other available guidances, and MAPPS regarding meetings and submissions. For those items which do qualify for a less formal process, three days is the default for an FDA acknowledgement. The acknowledgement may include the answer to the question if that works out, but otherwise it will be a high level description of the steps FDA needs to go through to formulate the answer, and an estimated time frame for a response, or a recommendation that the sponsor make a meeting request or request for WRO, or a recommendation that the sponsor contact another specialized functional area in FDA. Also emphasized is the importance of prompt sponsor acknowledgement.
Concerning best practices, FDA wants to make sure it’s communication are clear:
Importantly, FDA adds this caveat regarding its responses to sponsors questions and other advisements:
The IND phase of drug development is typically a multiyear process, and FDA staff recognize that new data will become available and that scientific advances and changes in clinical practice may occur during this time. Because sponsors are ultimately responsible for managing the overall development program for their proposed drug, sponsors should closely monitor for advances in the field and/or changes in FDA guidance, and inquire if those changes may necessitate changes in prior FDA recommendations for their development program. Although FDA reviewers consider new information and revise recommendations as needed, they try to support and adhere to their prior critical recommendations where appropriate. Changes in recommendations are expected to be based on new scientific or safety information or advances in clinical practice that make earlier FDA recommendations outdated, inappropriate, or unethical. In such cases, review staff via the project manager should inform sponsors in writing of these changes and the rationale behind the changes.” (Emphasis added)
In other words, you may have it in writing, but that doesn’t mean it’s written in stone. You need to keep current and assure your application will meet standards at the time of submission.
The guidance provides FDA’s viewpoint on 4 types of meetings:
The guidance provides a fairly useful summary for Meeting Requests, Meeting Packages, Meeting Conduct and Meeting Minutes.
The guidance becomes more specific when discussing the mechanics of written correspondence, submissions from sponsors, acknowledging receipt of communications, email, telephone and fax communications between the FDA and sponsors, even getting down to the use of out-of-office messages.
The guidance concludes with the aforementioned list of resources for sponsors, which is fairly comprehensive, and Section VIII, which lists additional contacts at FDA for special issues, e.g., Controlled substance staff.
Interestingly, scattered throughout the guidance are brief descriptions of the appropriate steps to take if it seems that the appropriate party or parties are unresponsive to a sponsor’s inquires.
All in all the guidance is a good primer for those involved in communicating with FDA during drug development under an IND. Also, as mentioned earlier, it creates at least the possible prospect of greater uniformity across the FDA review Divisions.
Camargo is frequently involved in all of the activities described in the draft guidance. If there are questions beyond what the guidance has to offer, Camargo is available to assist.
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