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FDA issues draft guidance on communications with sponsors

Monday, December 21, 2015

The FDA has released draft guidance regarding its position on early and efficient communications during drug development as a key way to reduce approval times between the agency and Investigational New Drug (IND) sponsors.

Each year, both sides engage in thousands of formal and informal communications—including meetings and teleconferences—often to share critical information on clinical trials and to let the FDA provide advice on trial design, dose selection, nonclinical study requirements and manufacturing and facility issues.

“It is important that interactions be conducted efficiently and consistently, with clear, concise and timely communications,” the FDA stated in announcing the availability of the draft guidance for industry and review staff. Its purpose “is to describe best practices and procedures for timely, transparent and effective communications between INDs and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public.”

For Bryant Storm, an analyst at Wolters Kluwer Legal & Regulatory Solutions in New York, the draft guidance confirms current FDA review practices that are aimed at streamlining the process.

“However, the goal of the draft guidance was not to outline new policies, but instead to provide IND sponsors with a set of best practices for communication with the FDA throughout the drug development process,” said Storm, who wrote about the draft guidance in his law firm’s Health Law Daily.

The 35-page draft guidance, titled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development,” says it is appropriate for sponsors to seek scientific and regulatory advice—including clinical and statistical, safety, regulatory, clinical pharmacology and pharmacokinetics, nonclinical pharmacology, pharmacokinetics and toxicology, product quality and pediatrics.

“This guidance helps us better understand how critical it is to have early and continuous communication with the FDA in order to maximize expeditious drug development,” said George Hemsworth, PPD’s senior director of clinical-regulatory consulting.

The draft guidance also acknowledges the FDA’s limited resources and encourages sponsors to seek answers to scientific and regulatory questions from other available resources before contacting the agency.

During the lifecycle of drug development, the primary endpoint of contact for communications between IND sponsors and FDA is the review division regulatory project manager (RPM). He or she is the main contact for facilitating timely resolution of technical, scientific and regulatory questions, conflicts or communication concerns between the sponsor and the FDA review team.

“The key to working with the FDA is to funnel all communications through the RPM, from general review matters to specific questions directed to clinical, nonclinical and quality reviewers seeking information on response timeline expectations,” said Hemsworth. “To promote strong communication between the client and the FDA, understanding the RPM’s role, responsibilities and accountabilities is a vital step.”

Although there are circumstances where sponsors may contact other FDA representatives, the draft guidance stresses that while reviewers assigned to a sponsor’s IND can expedite the exchange of information and progress in their drug development programs, sponsors should not contact FDA reviewers directly; instead, all inquiries should be directed to the RPM who will communicate them appropriately to supervisors and reviewers. Moreover, direct contact with reviewers can result in responses that are inaccurate or have not been properly vetted by the reviewer team and supervisors. For sponsors who encounter difficulties getting feedback from the RPM, they should contact the RPM’s next-level supervisor.

The draft guidance also suggests that sponsors consider employing an independent consultant to help them and the FDA conserve resources to address the more complex and challenging drug development issues.

As for the promptness of IND-related inquiries, the draft guidance says the FDA intends to respond more quickly to safety-related questions.

The agency also acknowledges that sponsors sometimes pose questions to the FDA that they perceive as being simple or clarifying questions with the expectation that only minimal time will be needed for an FDA response. What may be simple or clarifying to the sponsor, however, may require significant review and communication among review team members before they are answered.

While complex scientific/technical policy or regulatory questions are best posed in either formal meetings or in formal submissions, sponsors who make inquiries via telephone or email should receive FDA acknowledgment of receipt of those messages within three business days. In turn, sponsors should acknowledge their receipt of FDA information requests.

“Note that although FDA strives to adhere to all established or estimated response timelines, FDA may not always be able to meet these deadlines,” the draft guidance cautions.

To generate some uniformity in the IND communication practice, the draft guidance also sets out best practices in terms of understanding terms and phrasing that are used consistently by the FDA and sponsors.

“The highlighting of specific words or topics is the FDA’s way of signaling to the industry which topics weigh most significantly on safety and effectiveness determinations,” said Storm. “One point of focus that stands out is the FDA’s emphasis not only on clarity and efficiency of communications, but the timeliness of those communications as well … and the need for IND sponsors to begin communication with the FDA early in the drug development process.”

The FDA is seeking comments on its draft, which was developed by the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER). The guidance will be finalized 18 months after the 60-day comment period closes. 


Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology. 

This article was reprinted from Volume 19, Issue 50, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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