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2016 Will Be A Big Year For Combo Product Reform, FDA Says :: “The Gray Sheet” :: ...

Page 1 of 4

Related Articles: 9
This copy is for your personal, non-commercial use. For high-quality copies or
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+1 (908) 547-2200.
Printed by Mr. Norm Rabin, Maetrics LLC

2016 Will Be A Big Year For Combo
Product Reform, FDA Says
By Ferdous Al-Faruque / Email the Author
Top Stories / Word Count: 1273 / Article # 01160104002 / Posted: December
29 2015 3:15 PM

Executive Summary
The agency has already signaled its plan to propose a new statutory pathway
for combination products by the end of next year. In the meantime, it's
working on a bevy of process changes, guidance documents and rules to
enhance premarket and postmarket regulation of combination products in the
years ahead. Office of Combination Products officials John Weiner and Thinh
Nguyen weigh in.

Questions about the future regulation of combination products came to a head in
2015, and it's likely that significant changes will be put on the table in 2016.
From FDA, companies can expect a comprehensive proposal for a new approval
pathway focused on combination products by the end of next year that could
dovetail with efforts to reauthorize the device and drug user fee programs in 2017.
Deputy Commissioner (and Commissioner-nominee) Robert Califf committed to as
much at a recent congressional hearing. (See "Califf Supports Combo Products
Pathway At Confirmation Hearing" — "The Gray Sheet," Nov. 17, 2015.)
But even before such comprehensive reforms are put forward, incremental changes
are already in the works. FDA is updating its processes to improve informationsharing and collaboration between centers, and will issue guidance documents with
the hope of streamlining premarket combination product reviews, as well as
postmarket compliance efforts.

Califf Supports Combo Products
Pathway At Confirmation
Hearing
“The Gray Sheet” Nov. 17, 2015
FDA Says It's Taking Steps To
Simplify Combo Product
Consultations
“The Gray Sheet” Oct. 15, 2015
Senate Bill Aimed At
Streamlining Combo Product
Regulation
“The Gray Sheet” Jul. 20, 2015
Combo Product Reforms Are A
Priority For Next User Fee
Round, FDA Officials Say
“The Gray Sheet” Jun. 24, 2015
Podcast: FDA's Califf Talks
About Combo Product Reform,
Commish Prospects
“The Gray Sheet” Jun. 17, 2015
Manufacturers Seek More Clarity
On GMP Obligations For Combo
Products
“The Gray Sheet” May 11, 2015
Human Factors Questions Drive
Rise In FDA Inter-Center
Consults
“The Gray Sheet” May 7, 2015
Combo Products GMP Guidance
Fills In Gaps On Drug-Delivery
Device Compliance
“The Gray Sheet” Jan. 27, 2015
FDA Unveils Adverse Event
Reporting Rules For
Combination Products
“The Gray Sheet” Oct. 5, 2009

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/1/2016-will-be-a-big-... 12/31/2015

2016 Will Be A Big Year For Combo Product Reform, FDA Says :: “The Gray Sheet” :: ...

"Dr. [Stephen] Ostroff and Dr. [Robert] Califf have been clear that this is a priority
area and we hope to provide you with more detail about forthcoming projects in this
first quarter of 2016," Thinh Nguyen, director of FDA's Office of Combination
Products, told "The Gray Sheet."

Postmarket Particulars:
cGMPS, Safety Reporting

Ongoing FDA reforms "will
assure inter-center consults
are sought when needed,
that review staff know whom
to consult, and that timing
for completion of consults is
appropriate to enable the
lead center to meet its userfee performance goals,"
FDA's Thinh Nguyen says.

FDA issued a draft guidance at the start
of 2015 on the application of current good
manufacturing practices (cGMPs) to
combination products; it is intended as a
companion to a 2013 final rule on the
topic. (See "Combo Products GMP
Guidance Fills In Gaps On Drug-Delivery
Device Compliance" — "The Gray
Sheet," Jan. 27, 2015.) Both the rule and
the draft describe an approach for combo
products to comply with FDA quality
standards if a company implements either drug cGMPs
or the device Quality
System Regulation
, plus select sections of the other standard.

Page 2 of 4

Topics Covered in this
Article
Click a keyword for related
articles.
Subjects
Clinical Development & Trials
Commercial
Innovation
Personalized Medicine
Regulatory
Manufacturing
Industries
Medical Devices
In Vitro Diagnostics
Biopharmaceuticals
Laboratory Testing Services

While companies say the overall approach laid out in the regulation is appropriate,
much more explanation is needed from FDA to help manufacturers comply for
specific combo products. The draft guidance did not go far enough in providing the
needed clarity, many firms say. Specifically, companies are requesting more details
on how to apply stability testing and reserve sample requirements to different types
of products. Companies also want more help with the proper approach to device
design controls and cross-labeled products. (See "Manufacturers Seek More Clarity
On GMP Obligations For Combo Products" — "The Gray Sheet," May 11, 2015.)
The agency says it has reviewed the comments and is preparing a final guidance.
"The industry requested that FDA develop guidance to explain the requirements
and agency expectations further," John Weiner, associate director for policy at the
Office of Combination Products, said in an interview. "FDA is reaching out to the
combination products industry to understand and address their questions and
concerns about compliance with cGMP requirements."
Thus far the agency has met with the Combination Products Coalition and
AdvaMed's Combination Products Committee to collect feedback on the issue. The
agency is also working with individual companies to answer product- and facilityspecific questions.
Also in the postmarket realm, FDA says it's stepping up efforts to finalize its
proposed rule for adverse event reporting for combination products, which has been
pending for more than six years. (See "FDA Unveils Adverse Event Reporting Rules
For Combination Products" — "The Gray Sheet," Oct. 5, 2009.)
"FDA receives questions regularly on these reporting duties, and the Combination
Products Coalition, as well as individual members of the combination products
industry, have told the agency that they support finalizing the rule so that they can
make decisions on how to establish and update their reporting IT and systems,"
Nguyen said.

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/1/2016-will-be-a-big-... 12/31/2015

2016 Will Be A Big Year For Combo Product Reform, FDA Says :: “The Gray Sheet” :: ...

Page 3 of 4

Putting The Pieces Together
On the premarket review side, FDA officials acknowledge that there are gaps and
inefficiencies in how the different product centers collaborate and share information
during combo-product reviews, Nguyen noted. Califf made this point too in an
exclusive podcast interview with "The Gray Sheet" in June. (See "Podcast: FDA's
Califf Talks About Combo Product Reform, Commish Prospects" — "The Gray
Sheet," Jun. 17, 2015.)
The matter was underscored in an FDA internal assessment of its inter-center
consultation process released in October that spotlighted shortcomings in the
agency's IT systems, procedures and resource-allocation methods. (See "FDA Says
It's Taking Steps To Simplify Combo Product Consultations" — "The Gray Sheet,"
Oct. 15, 2015.)
FDA is now in the process of implementing the report's recommendations, Nguyen
affirmed. As part of that, the agency is updating its procedures for inter-center
consults to replace current processes that are more than a decade old.
"They will assure inter-center consults are sought when needed, that review staff
know whom to consult, and that timing for completion of consults is appropriate to
enable the lead center to meet its user fee performance goals," Nguyen said. "IT
adjustments are also being made to enable timely inter-center access to databases
needed for combination products reviews, and efficient coordination and oversight
for these activities."
The reforms come as FDA struggles to handle the rapid rise in inter-center consults.
A particularly large number of information requests come to the device center from
the drug center, asking about human-factors issues raised by drug-delivery
technologies. (See "Human Factors Questions Drive Rise In FDA Inter-Center
Consults" — "The Gray Sheet," May 7, 2015.)
FDA is trying to address common confusions in that particular area by prioritizing
development of a draft guidance document this year on human factors design for
combination products, Nguyen said.

A New Pathway?
But all of this does not get to the broader
questions of whether the established
device and drug approval processes
provide the necessary flexibility for the
review of next-generation combination
products or whether a new statutory
pathway is needed.

"FDA continues to believe
that a new pathway for
device-led combination
products could help to
address challenges that
currently face
manufacturers and FDA,"
OCP's John Weiner says.

About 10 years after FDA established the
"primary mode of action" rule that
underpins current combination products regulation, there is growing consensus
from industry and within the agency that a significant update to the program is
needed.
Both Califf and Center for Devices and Radiological Health Director Jeffrey Shuren
have publicly touted prospects for a new pathway, potentially with new user fees to

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/1/2016-will-be-a-big-... 12/31/2015

2016 Will Be A Big Year For Combo Product Reform, FDA Says :: “The Gray Sheet” :: ...

Page 4 of 4

support it. Shuren has said that the number of combination-product consultations
within the agency is especially burdensome for the device center and that the drug
and device pathways don't align very smoothly to support a streamlined
combination-product review. (See "Combo Product Reforms Are A Priority For Next
User Fee Round, FDA Officials Say" — "The Gray Sheet," Jun. 24, 2015.)
"FDA continues to believe that a new pathway for device-led combination products
could help to address challenges that currently face manufacturers and FDA,"
OCP's Weiner also told "The Gray Sheet."
"On the one hand, manufacturers for some types of combination products may be
concerned that the PMA pathway is overly burdensome given the nature of the
products they seek to market. On the other hand, the 510(k) pathway presents
challenges for combination products because it is designed to assess the
substantial equivalence of devices, not the safety or effectiveness of drugs."
Exactly what a new pathway would look like remains to be seen. And there is also
the question of the agency's standard for determining whether a product in fact has
a device or drug primary mode of action. Companies have increasingly complained
that FDA too often leans toward sending products down the primary drug review
route, with its more burdensome standards. At least one bill introduced in the
Senate in 2015 seeks to push more combo products into device-led reviews. (See
"Senate Bill Aimed At Streamlining Combo Product Regulation" — "The Gray
Sheet," Jul. 20, 2015.) That issue will certainly be part of the discussion as
combination-product reform efforts escalate in 2016 and as user fee reauthorization
moves to conclusion in 2017.
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200.
Printed by Mr. Norm Rabin, Maetrics LLC

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