News

April 9, 2019

CPC Comments on CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Draft Guidance

On April 9, 2019, CPC provided comments on FDA’s proposed CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. Our comment letter asks FDA to provide a number of clarifications in the Draft Guidance, including: (1) confirming that the scope of the Draft Guidance includes combination products under CDER jurisdiction; (2) clarifying how the proposed CDER Program will align with the CDRH Standards and Conformity Assessment Program for the device constituent(s) of combination products under CDER jurisdiction; (3) clarifying how the informal nature of the CDER Program will ensure predictability and consistency across CDER for the same device constituent and the same standard; and (4) clarifying the type of standards that are expected to be a part of the CDER Program.

March 7, 2019

CPC Provides Comments on FDA’s Proposed Rule for the Medical Device De Novo Classification Process

On March 7, 2019, CPC provided feedback on the proposed rule for the Medical Device De Novo Classification Process. As part of this feedback, CPC notes that it concurs with and supports the applicability of the De Novo process to the device constituent of what are commonly referred to as “cross-labeled” combination products, and asks FDA to consider including “co-packaged” combination products (per 21 C.F.R. § 3.2(e)(2)) that are designated as device mode of action in the De Novo process, as such products would also benefit from the application of least burdensome provisions and potentially classification as Class II devices.

January 22, 2019

CPC Comments on FDA’s Proposed Framework for Regulating Software Intended for Use with Prescription Drugs

On January 22, 2019, CPC provided input on the Federal Register Notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.” While the CPC applauds the Agency’s efforts to develop a proposed framework to address the ever-increasing array of digital innovations associated with pharmaceuticals, the CPC has certain concerns regarding the proposed framework, as discussed within the comment letter.

December 3, 2018

CPC Requests Extra 30 Days to Comment on FDA’s Proposed Framework for Regulating Software Intended for Use with Prescription Drugs

The CPC has been intently focused on the issue of how FDA will regulate software developed for use with drugs and believes additional time (until February 21, 2019) for commenting on FDA’s proposed framework is warranted given:

•  the timing of the commenting period (which falls across the holidays);
•  the length and complexity of the proposal;
•  the limited window for potential discussion with FDA before submitting comments; and
•  the fact that an extension is unlikely to harm the interested parties.

November 30, 2018

CPC Provides Comments on FDA’s “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications: Draft Guidance for Industry and FDA Staff”

While CPC supports certain recommendations detailed in the Draft Guidance, we also recommend several revisions.  For example, we ask that FDA revise the document to provide clear guidance and delineation as to which HF tools are applicable to which types of submissions/situations. We also ask that FDA only request that sponsors provide representative samples of their own product for certain submission types and remove the request for samples of competitors’ reference products.


January 19, 2018

CPC Conducts Survey on FDA’s Final Rule on Postmarket Safety Reporting for Combination Products

The Combination Products Coalition (“CPC”) is conducting a brief survey to assess industry readiness for implementation of FDA’s Final Rule on Postmarketing Safety Reporting for Combination Products (available here). We hope to use your responses to help advise FDA on reasonable expectations for how long it will take companies to come into compliance with the Final Rule as well as provide insight about potential hurdles, recognizing that FDA guidance on the Final Rule is still forthcoming.  All of your responses will be kept anonymous.

We would like to have one response per applicable survey (combination product, companion diagnostic, or both) from each company or independent business unit so that information is not duplicated.  Therefore, we ask that you designate an individual at your company/unit to collect information from, and complete a single survey for, the company/unit.  We estimate that it will take approximately 10 minutes to complete the survey.

Take the survey here: https://www.surveymonkey.com/r/MGGXK9D

Please Complete the Survey No Later Than February 2, 2018.

We thank you in advance for your participation. If you have any questions, please feel free to contact Priya Kaulich at PKaulich@ebglaw.com or 312.499.1433.

March 7, 2014

CPC Conducts Surveys on FDA’s Review Process for Combination Products & Companion Diagnostics

The Combination Products Coalition (“CPC”) is conducting anonymous on-line surveys to gather data on manufacturers’ experiences with the review process for combination products and companion diagnostics.  The objective is to help identify areas where there may be problems with, e.g., interCenter or Center-sponsor, communications so that industry and FDA can figure out ways to improve reviews.  We plan to share our results from this survey with FDA and, potentially, with Congress and the broader public to advocate for process improvements.

The surveys ask about your company’s interactions with FDA to identify problems that may have had a significant effect on product review.  The questions are multiple choice, although some include additional space for comments or specific details you would like to share.  Also, there is a spot to provide your contact information if you would like to identify yourself or be contacted to discuss issues further.  Contact information will remain confidential and will not be shared with FDA or other individuals beyond the CPC survey administrators without your express permission.

We would like to have one response per applicable survey (combination product, companion diagnostic, or both) from each company or independent business unit so that information is not duplicated.  Therefore, we ask that you designate an individual at your company/unit to collect information from, and complete a single survey for, the company/unit.  We estimate that it will take no longer than 15-30 minutes to complete the survey.

The Combination Product Survey is available at: http://www.surveygizmo.com/s3/1558128/867c9fffe187

The Companion Diagnostic Survey is available athttp://www.surveygizmo.com/s3/1561635/Companion-Disgnostics-Survey

Please Complete the Surveys No Later Than April 21, 2014.

We thank you in advance for your participation.  We believe the results will be tremedously useful in improving the review process and bringing safe, effective, and innovative products to patients more quickly.

If you have questions about the surveys or the CPC, please feel free to contact James Boiani at JBoiani@ebglaw.com or 202.861.1891.

May 1, 2013

Op Ed: Counting Our Blessings with the Office of Combination Products

Why the OCP might still be the best thing that has ever happened to industry.

As reported in Seriously, What is Going On at the Office of Combination Products?, some in the medical device community have criticized the Office of Combination Products (OCP) at FDA. In particular, those critics have accused OCP, ironically, both of being weak because the office lacks independent authority and for overstepping its bounds. How is that even possible?

But it is that criticism which is out of bounds.  Since its inception, OCP has served as an important resource to combination product manufacturers of all shapes and sizes.
OCP consistently helps manufacturers navigate the murky and sometimes stormy waters created by the cross-center regulation of their products. I frequently hear stories from companies in the combination product space about how OCP interceded when a dispute arose either between centers, or between the centers and the sponsor. The office has acted like an ombudsman on steroids, specifically focused on the unique issues associated with combination products. Indeed, they get some of the highest marks of any office at FDA when it comes to responding quickly to pleas for help.
OCP also drives the development of combination product guidance and ensures issues central to combination products are incorporated into center-specific and cross-center guidance documents. OCP’s value has not diminished and is not likely to anytime soon. This is particularly true as combination products are becoming more ubiquitous and the twenty-plus year old inter-center agreements need refreshing.
Representing industry, the Combination Products Coalition (CPC) has worked closely with OCP almost since its inception. While we may not agree on all matters and occasionally wish OCP could do more and faster, the office is an extremely valuable resource. For example, OCP recently finalized the combination product Good Manufacturing Practices regulations and is actively working with the various centers to develop implementation guidance to add specificity underneath the regulations. As part of the development of this guidance, OCP served as a valuable facilitator, bringing industry representatives and FDA together soon after the final rule was published to discuss topics that the guidance should address.
As combination products become more prevalent and their regulation continues to evolve, the CPC looks forward to continuing to work with OCP to address such areas as:
  • Clarifying the roles and responsibilities of OCP vis-a-vis the various centers.
  • Updating the inter-center agreements.
  • Developing guidance on human factors and usability testing for combination products.
  • Tackling the unique issues associated with conducting clinical trials on combination products.
  • Enhancing transparency through the publication of Request for Designation letters.
There will always be people unhappy with any system. As a coalition that includes medical device, drug, and biological product manufacturers large and small, we spend an enormous amount of time discussing policy proposals to ensure that they are the best for the patients we all serve. Certainly there are many manufacturers of drug-device combination products that would prefer to be regulated as devices. But that isn’t always possible or appropriate.

At a coalition, we don’t always see eye to eye with OCP, but we are very glad to have them managing the combination product issues within the agency. For those of us who are getting on in years, we remember what life was like before OCP, and the old days clearly were not good for combination products. We are lucky to have those days behind us and OCP going forward.

Published: April 29, 2013, Medical Device and Diagnostic Industry

February 5, 2013

CGMPs for Combination Products–Final Rule and Implementation: An Interactive Analysis with Industry and FDA

In the wake of the U.S. Food and Drug Administration (FDA) issuing the final rule on current Good Manufacturing Practices (CGMPs) for combination products, the Combination Products Coalition (CPC), in collaboration with the Regulatory Affairs Professionals Society (RAPS), will be hosting an interactive session examining the contents of the final rule and the agency’s implementation plan.

During the program, happening on Thursday, February 28th at the RAPS Training Center in Rockville, MD, attendees will hear directly from experts at each of the FDA centers and industry regarding what the final rule includes, with an emphasis on deviations from the proposed rule. In-person attendees will work with industry peers in case study breakout sessions, where they will have the opportunity to apply the final rule, analyze the rule’s remaining ambiguities and identify approaches for effective implementation. During the final recap session, the expert facilitators will present and connect major themes identified during the breakouts, and all attendees will have the opportunity to provide feedback directly to the experts at the various centers responsible for developing the implementation guidance regarding any other ambiguities not addressed in the case studies.

CPC and RAPS will collaborate to compile the major themes that emerge from the program regarding implementation and submit them to FDA for consider in developing its implementation guidance.

The program is intended for manufacturers (including contract manufacturers), combination product developers, consultants and legal counsel who are involved in regulatory, quality and compliance at all professional levels and can be attended in person or via webcast. For more information and to register, please visit the RAPS event page. As capacity for this event is limited, early registration is encouraged!

January 23, 2013

Combination Products Coalition pleased with FDA publishings

The Combination Products Coalition is pleased to see the FDA guidance published on when submissions would be required for postapproval modifications to a combination product. Although we will continue to review individually and as a coalition our initial assessment is that it would increase the number of filings pretty radically by declaring that low risk device constituent parts are all of a sudden to be viewed through the PMA lens.

This is quick reaction, and we will be studying the document in more depth and filing comments. We appreciate FDA’s efforts to bring some clarity to this very murky area, and we truly appreciate the complexity of the task, but we are concerned that the current draft made needlessly and significantly increase the number of postmarket submissions combination product companies need to file.

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