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From Health Law Daily, December 9, 2015

Drug sponsors get a talking-to on talking to the FDA

By Bryant Storm, J.D.

The FDA released a draft guidance on the agency’s position regarding best practices for communication between investigational new drug application (IND) sponsors and the FDA during drug development. The draft guidance is designed to help sponsors communicate with the FDA in a timely, transparent, and effective manner so that safe and effective drugs can make it to market sooner (Notice, 80 FR, 76504, December 9, 2015).

RPM. The review division regulatory project manager (RPM) is the primary point contact point between sponsors and the FDA during the IND process. As a co-leader of the FDA review team, the RPM has knowledge of the drug and its regulatory history. Accordingly, it is the RPMs responsibility to facilitate the resolution of technical and regulatory questions. Although there are circumstances where sponsors may contact other FDA representatives, the draft guidance explains that sponsors should not directly contact FDA reviewers. Inquiries should be directed to the RPM who will communicate inquires appropriately to supervisors and reviewers. The draft guidance warns that direct contact with reviewers can result in responses that are inaccurate or have not been properly vetted by the review team and supervisors.

If the RPM is not responding in a timely manner, the draft guidance encourages sponsors to contact the RPM’s next level supervisor. Additionally to establish mutually agreeable expectations, the FDA recommends that sponsors establish preferences and expectations with FDA project managers and the RPM early in the IND process.

Types of advice. The draft guidance explains that it is appropriate for sponsors to seek scientific and regulatory advice with respect to the following topics areas: regulatory; clinical and statistical; safety; clinical pharmacology and pharmacokinetics; nonclinical pharmacology, pharmacokinetics, and toxicology; product quality; and pediatrics. Due to limited FDA resources, the draft guidance encourages sponsors to seek answers to scientific and regulatory questions from other available resources before contacting the FDA. The draft guidance suggests that sponsors consider employing an independent consultant to help sponsors and the agency conserve resources for such technical and regulatory matters.

Timing. With respect to the promptness of IND related inquiries, the draft guidance explains that the FDA intends to respond more quickly to safety related inquiries. Additionally, questions involving technical or regulatory issues may take more time than other questions because of the complexity of the matters involved. The draft guidance also explains for communications that are not either formally submitted or shared at a meeting with the FDA, sponsors should expect to receive an FDA acknowledgment of the receipt of those email or telephone communications within 3 business days of the receipt of the message. Similarly, sponsors should acknowledge the receipt of FDA information requests.

Best practices. The draft guidance also sets out best practices to generate some uniformity in the IND communication process. For example, FDA staff will use words such as “shall, must, required, or requirement” to convey a statutory or regulatory requirement. On the other hand, to communicate advice, the FDA will rely on words such as “advisable, critical, important, may be appropriate, should, consider, discourage, encourage, prefer, recommend, suggest, or urge.” Additionally, the draft guidance explains protocols and expectations for meetings, formal submissions, telephone calls, faxes, and emails.

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