Special Article Reprint • December 21, 2015
A CenterWatch Publication
FDA issues draft guidance on communications with sponsors
By Ronald Rosenberg
CenterWatch Staff Writer
T
he FDA has released draft guidance regarding its position on early and efficient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announcing the availability of the draft guidance for industry and review staff.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York, the draft guidance confirms current FDA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“However, the goal of the draft guidance was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about the draft guidance in his law firm’s Health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The 35-page draft guidance, titled “Best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The draft guidance also acknowledges the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
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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 deadcenterwatch.com
CWWeekly December 21, 2015
lines,” 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
2 of 2
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
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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. Email comments to Ronald at
[email protected].
Follow @RonRCW
centerwatch.com