Combination products—combinations of drugs, biologics, or devices that are physically, chemically, or otherwise produced as a single entity, such as prefilled syringes, metered dose inhalers, or drug-eluting stents—have become important healthcare tools in the last decade.  Regulations and guidances affecting these products have been promulgated since the final GMP rule covering them was finalized in January 2013 and a guidance explaining it was released four years later (Editor’s Note: Links to all documents referenced in the article can be found at the end).

At the Xavier Health Combination Products Summit held virtually in late October 2020, John “Barr” Weiner, Associate Director for Policy, Office of Combination Products (OCP), provided a detailed review of the numerous policy and guidance changes issued by his office during the last year.  He focused on recent pending and published policies, procedures and training OCP has conducted.  Weiner’s talk also offered a look at future activities, including the use of risk management in product evaluation and decision making and opportunities for regulatory convergence.

A Review of Recent Documents

Barr began by reviewing documents that have been released recently (Figure 1).  

“I am not going to go through the entire list,” he said, “but I will give you a sense of the volume of activity and discuss in more detail those that I think were most significant.”

FIGURE 1 | Updates – Recently Released Policies/Guidance

The multiple function guidance, for example, “I am highlighting because it goes to the issue of how we regulate software in part.  That is an area of ongoing interest and questions in the combination products space.”

The GMP compliance program is an effort to get OCP’s expectations “finally” in writing for inspections and for investigators. 

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“There was a realignment program in ORA over a period of years, and we had to hold off on combination products updates until that was completed and rolling.  It got rolling, and now we have put our program together, which leverages the compliance programs for drugs, devices, and biologics.”

The program talks about how investigators should engage with the Centers and how the Centers should engage with each other.  It reflects what OCP is already doing in terms of policy, gives a sense of how it approaches inspections, whether it is a pre-market approval inspection, or a post-market, or a surveillance, or a for cause, and whether it is a full inspection or an abbreviated inspection.

“We did a massive training on that earlier this year,” Barr reported.  “One of the consequences of the pandemic was that we had a lot of people on the bench.  So, it was fairly easy to get a lot of people trained quickly.  As soon as that compliance program was about ready to launch, we basically trained the whole ORA staff that would be involved with these inspections.”

There was an agency decision in May not to pursue a “devices referencing drugs” proposal for device marketing approval. 

“We pulled back our proposal.  We are trying to help folks work through the situation where you have a device you want to bring to market for a new use of an approved drug, and we have some ideas for what we might do about that.  We got a lot of feedback from industry and decided that without at least some Congressional engagement we did not really think we could do much better right now beyond our current practices.”

Now we have put our program together, which leverages the compliance programs for drugs, devices, and biologics

The Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA draft guidance from April addresses the issue of how the agency approaches emergency use products and that its expectations vary based upon the nature of the use of the product.

“There were some concerns in the industry that it was a one size fits all approach that might be unduly onerous. That is not our thinking,” Barr said.  “Our institutions reliably do relate back to the use of the product and setting for use—in this case, emergency use—which needs a high priority for reliable use.”

The final rule from February on definition of protein for purposes of the statutory definition of a biological product. 

“It is important if you work in that space to know that if you have a protein in your product that means you have a biologic in your product,” Barr pointed out.  That means if it is combined with a drug or device you have a combination product.

The FDA feedback on the combination products draft guidance from last December is a statutory mandated guidance.  The final guidance is supposed to be out by the end of the year.  It is in the final clearance stage.

“We tried to provide some additional clarity and address comments received.  This has been a challenging year for publication, but this one is a priority since it is a Congressional mandate,” the OCP Associate Policy Director pointed out.

The Pre-market Bridging for Drug-Device and Biologic-Device Combination Products draft from late 2019 is a PDUFA VI commitment.  The final guidance is supposed to come out by 2022.  The draft is out and OCP is trying to get a sense for how it would approach different situations.

“It provides a lot to think about,” Barr commented.  “The topic is broadly framed.  We got some feedback on it, including whether we should have an additional workshop.  We appreciate that it is an important topic for the industry that we will keep working on.  This is a CDER-led project that we are involved in along with other Centers.”

What is Pending?

In terms of pending priorities, there are several guidance documents in progress that are a priority for completion (Figure 2).

Figure 2 OCP Policy Updates Pending Priorities
FIGURE 2 | OCP Policy Updates – Pending Priorities

Pre-market Pathways Draft Guidance

A pre-market pathways draft guidance that came out in 2019 is an agency priority for this year. It is in final clearance and due out by the end of the year.  “It is kind of a pillar document in the sense that it does not really say anything that is new,” Barr said.  “It pulls a lot of things together that are important.  It talks about basic principles, how we approach regulation of combination products, and the pre-market review in broad strokes regarding how we review things and how we coordinate standards and expectations.”

It talks primarily about what pathways would be available under what circumstances for combination products.  It provides guidance whether a company is trying to pursue, for example, a comparative analysis, which might be appropriate under a 510(k), or an NDA where the firm needs to develop independent findings of safety and effectiveness, which might mean an NDA or a PMA or a De Novo application depending on the primary mode of action (PMOA).

The draft explains that the 21st Century Cures Act in 2016 clarified that the De Novo pathway is available for combination products.  There is discussion of the De Novo pathway in the draft.

“We have already had applications regarding that pathway,” Barr pointed out, “so it is not announcing something new in the guidance, but it is discussing a new area in the sense that we have not had a lot of experience with those pathways for combination products yet.  Having some guidance on that is certainly helpful.”

Human Factors Guidance for Combination Products

Also being finalized is a human factors guidance for combination products, which explains how to apply human factors—principles that are largely reflected in the existing medical device guidance that apply to combination products and how they relate to things like medication error.

FRN on CGMP Alternatives/Flexibilities

OCP is also mandated by the 21st Century Cures Act to issue a Federal Register notice regarding flexibilities and alternatives for compliance with CGMP requirements for combination products.  This is an effort to make sure the agency gets something out on policy relating to the Part 4 rule.

The Cures Act was enacted shortly before OCP’s final guidance on the topic issued.  And while industry knew it was supposed to issue, they had not seen it yet, so the agency wanted to make sure something got out.

“This is a push in that regard,” Barr explained. “Consequently, the alternative proposal speaks to some clarification of the guidance. It relates back to the feedback guidance, to some extent, which talks more broadly about how to engage with us for feedback.”

Draft Guidance on Cross Labeling

A draft guidance on cross labeling was scheduled to issue in 2020.  It is in progress but will not publish until 2021.

Essential Performance Requirements Guidance

Also in progress is the Essential Performance Requirements (EPR) guidance that OCP Health Policy Analyst Stephanie Shapley is taking the staff lead for.  This is an area that is also important for many companies.  There are a lot of questions in that space.

ICH Q12 Implementation Guidance

The ICH Q12 implementation guidance on established conditions is being developed, which will address combination products as well as pharma products and inform the work that OCP has in progress.

Post-market Changes to Combination Products Guidance

The post-market changes to combination products guidance is a priority and it is being worked on with a redraft anticipated for 2021.  The guidance intends to clarify how things happen with a 510(k)-like device in a drug or biologic-led combination product, in particular.  OCP is also retriggering the guidance to provide a better sense of how the analysis is done practically to know what submissions are appropriate for industry and for OCP.

Co-packaged Ophthalmic Products

One draft guidance in progress will explain the agency’s interpretation of 21 CFR 200.50 regarding when co-packaged ophthalmic products are regulated as combination products or drugs.  This is an area that has spawned several questions over the last couple of years.

A question addressed here is, when is a device packaged with a drug regulated together with a drug as a drug rather than regulated together as a co-packaged combination product or a single entity combination product?  This guidance aims to help clarify classification of those products.

Other Policy Updates

The Part 820 regulations on device manufacturing are being amended to align more closely with ISO 13485 international standards.  “We are mindful of implications for Part 4 in this effort,” Barr said.  “We are involved to make sure that we end up in a place where we have taken into account combination products and what adjustments, if any, should be made to Part 4.”

The agency has also issued a proposed rule and guidance on importation of prescription drugs.  This is not a combination products specific activity, but it does implicate combination products.  It is a hot topic for the prescription drug industry.

It is important if you work in that space to know that if you have a protein in your product that means you have a biologic in your product

The prescription drug use related software (PDURS) policy development and guidance is one of the major initiatives regarding software use, including software as part of the combination product or used with a combination product.  There is highly active coordination on this topic happening inside the agency.  It goes to the issue of when software is regulated and the required or promotional front labeling and how that would work.

The last issue Barr highlighted in his presentation was the policy on device versus container/closure only status.  

“This is coming up more often,” he said.  “We are trying to work through clarifying exactly where the boundary lines are.  It is a subtle issue, because any container closure in theory could meet the device definition, but we certainly do not regulate them that way.  When do they become a device?  What is a pill bottle versus what is a syringe is kind of the question.  There are boundaries between the two and we are working that through.”

Updates on Procedures, Training, and Assessments

Regarding inter-center consults in the pre-market area, this relates back to some extent to the PDUFA VI review.  An internal assessment getting feedback from users was conducted and OCP made some IT updates and did some additional training after those updates considering that feedback.  “The general reaction internally is that the system works quite well.”

Regarding the consultation system, “the actual inter-center consult process is definitely much stronger than it used to be,” the OCP attorney said.  “Users are pretty happy with it.  In fact, they are happy enough with it that it is becoming a fairly routine mechanism for use for consultations across Centers whether it is for a combination product question or not, which I think is a good sign.  We are going to continue training on that.”

His office is also doing training more broadly on the issue of regulation of combination products in the pre-market setting to make sure that new staff are familiar with those concepts.  In addition, his office is ensuring that there are resources readily available for existing staff who have perhaps already gotten the training but have not seen combination products recently and need a reminder.

We are trying to work through clarifying exactly where the boundary lines are

In the post-market setting, OCP has a dashboard it has put together to help its safety staff readily access at least some data across databases that are housed and managed separately in different Centers to get a sense of what is going on.  It can be used to engage with a Center for more input and assistance that they will need to dig into a safety issue that cuts across constituent partner locations.

The final rule regarding internal use of the dashboard and its use came into full effect in July.  It performed training internally including on the process used to coordinate between Centers when that coordination is appropriate given the nature of the issue.

OCP continues to adjust its reporting instructions for industry to make sure they are as clear as possible. It made a few tweaks and included examples to give a sense of how to complete forms so it can get the kind of information it needs to work through issues together with reporting companies and track and trend events.

The agency has also been updating its systems to help track inspections with combination products and track the facilities that make combination products so that it can better assess how things are going in that space.

Looking Forward

Looking forward, OCP believes that risk management provides a good framework for its activities and decision making.  “We had an audit reflecting that our pre-market review of combination products is much the same as for non-combination products and generally runs quite smoothly,” Barr reported.

“This is not something to overstate, but the sort of questions we ask for a combination product depends on how much knowledge we have about constituent parts and leveraging existing data or findings when we have the authority to do so.”

There are areas where OCP needs to ask more questions about a combination product and areas where it needs to ask fewer questions.  This is driven by risk in terms of the use, the indication, the user population, etc.

“Refining our thinking around that and articulating our policy positions with a sharper focus on the nature of the risk differences and why they raise different questions may help us all with predictability and understanding the agency thinking and making sure we are all on an appropriate and consistent page,” he explained.

His office is also doing training more broadly on the issue of regulation of combination products

The agency has seen a lot of effort from sponsor firms in terms of modifying internal systems and getting the right people to talk to each other or hire the right people/setting up the right systems to address combination products.

“We have also discovered that it has been a somewhat siloed activity,” Barr said.  “There was a lot of work for GMP, then a lot of work for Post-Market Safety Reporting (PMSR) unless they are working in the pre-market setting.  But it seems like it happens incrementally based upon what topics the agency is focusing on.”

“Our recommendation is to step back and think about your products holistically from a risk management perspective—risk management written broadly, not just safety risk, but also developmental considerations, lifecycle management, etc.”  The Association for the Advancement of Medical Instrumentation (AAMI) has released a technical report ($$) on this topic that includes a basic framework.

The AAMI framework resulted in many companies in the industry agreeing among themselves along with AAMI committee members on a holistic approach thinking about the product at the product level, not just the risks and planning for each department. 

“The holistic approach is critical. We are trying to ensure sound practice and enhance clarity and consistency, and I think this is one way we can really help advance that ball,” Barr commented.

Opportunities for Convergence

In terms of convergence issues, “I think we are at a place now where we can again begin to talk about those issues,” the OCP Associate Director commented.  “There were some discussions about a decade ago that fell by the wayside largely because of questions of who was going to take the lead for the European Union.  Now they seem to be interested in engagement on the topics.  There has been some work done on forms and process.”

There is some work being done at ASTM (ASTM International, formerly known as American Society for Testing and Materials) on nomenclature.  There has been work that could be leveraged from AAMI and others for more international standard setting.

“I think there is an opportunity to start thinking about this more seriously in the next couple of years and see what we can do, at least coming together more on process,” he emphasized.  “And perhaps post-market might be easier than pre-market in terms of expectations.  But we need to help each other on resources and coordination for post-market inspections, for example.  And we are already working on that to some extent with some jurisdictions, so we could keep working on that for combination products.”

“Lastly, engagement is always important.  We appreciate companies giving us feedback.  At the policy level, working with trade groups has been tremendously valuable.   I think it has really helped us in the GMP space and the PMSR space.  When we have constructive conversations, we end up with better results through being more informed.”

Regulatory Documents

Current Good Manufacturing Practice Requirements for Combination Products (FDA Final Rule)

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products FINAL GUIDANCE

Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE

Requesting FDA Feedback on Combination Products Guidance for Industry and FDA Staff

FDA Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry DRAFT GUIDANCE

Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff DRAFT GUIDANCE

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