Interpreting Drug & Device Regulations In A Changing Landscape: The Impact of Innovation and COVID-19

Technology and innovation is challenging the regulatory landscape and presenting stakeholders (Drug Companies, Device Companies, Regulating Bodies) with new boundaries for interpretation.

With consistent new technology development, there is going to be a learning curve with regard to how regulations apply, both on the manufacturing side and even within the regulatory bodies that created the regulations.

Regulatory bodies are faced with applying current regulation to new technology and innovation without compromising patient safety and the interpretation of regulations that were put in place to guide the development and manufacturing of smart or non-smart combination products. This is most evident in the application of the FDA infusion pump guidelines and how they apply to devices, understanding what the overall on body infusion system needs to be. At times, you may be able to make an educated guess as to how guidelines will apply practically, but in most cases, it is best to open a dialogue to get recommendations straight from the regulatory body itself.

You can have an incredible experience talking with regulatory body agents to work through regulatory interpretations, problems, considerations and perspectives from both the manufacturer and regulatory sides.

While it may feel like overcommunication, regulatory feedback is not binding, so there’s nothing but gain when you take the time to make arguments and request feedback in unchartered territory.

Some manufacturers are concerned about preventatively bringing up potential issues. For example, additional guidance on reliability outside of emergency devices is being taken to the Nth degree, and it may feel like steering clear of the issue is the best method of avoiding it. Knowing that a certain hot button exists, we find that you are better off getting in front of it with a solid argument and data to back it up. These issues will eventually come up during your review cycle and it will serve you best to get it out in the open and discussed earlier rather than later.

Conversely, under-communication will inevitably lead to agent interpretation of your position toward what is common or best practices in their experience, not what might be practical or most effective for you, the manufacturer. Use the conversation to empower your project, not to collect points to be marked off on a checklist. Outlining the entire package for them, instead of providing simple broad strokes, will provide clarity as to the specifics of your own situation and a stronger likelihood of an outcome customized to your needs and intended pathway. This is especially the case when the pathway is not explicitly apparent.

When communicating with your regulatory body, it is important to make sure you have the right players in on the conversation.

You need agents that are authorities in each of the areas of expertise that your project touches – potentially ranging from dosing recommendations, distribution, patient feedback systems, medical support – whatever they might be. If the players do not have experience in these fields and are not advocates for your class of device, you will find a higher level of conservativism and more roadblocks than necessary being put in your way due to lack of understanding or knowledge of previous judgments. It’s appropriate to be vocal about the expertise that you think you will need at a particular meeting with regulatory bodies. These communications can occur during periodic conversations prior to scheduled meetings or in writing within the meeting request. Don’t be hesitant to advocate what will be best for productive conversations – both you and the regulatory body will benefit from including the right people in each meeting.

This leaves a new group of regulatory agents available for reviewing everyday drugs, who may not have the experience needed to get you 100% to confident recommendations. A similar situation to when the combination product ruling first came around. During this pandemic period, you will likely get interpretations and initial guidance that will point you in the right direction, but then you will need to make your own decisions and calls on issues. Or, on the flip side, you may get highly conservative, restrictive responses. The best defense for this scenario is a good offense, filled with strong opinions backed up by data, risk assessments and, unfortunately, a good deal of extra work.  

We are also seeing the pandemic interfering with regulatory agency progress due to limitations around in-person activities.

Manufacturers are finding themselves with incredible uncertainty because they need facility inspections to proceed…but inspections are still subject to priority status, inspector availability, and changing guidance right now because of COVID safety concerns. Be aware of this issue as you create your project timelines, and keep checking back with your regulatory body on updated protocols on in-person activities. As more and more people get vaccinations, in-person activities will begin to open up and you want to be ready and in queue to get on their schedule.

Steve Badelt, PhD – Steve is a seasoned expert with over 20 years of experience in combination products, engineering management, systems engineering, and business development. He founded consulting firm Suttons Creek, Inc. in 2012, which has served as the device team for pharma on over 50 combination product programs. Steve values helping others learn and grow, and when he is not consulting on behalf of Suttons Creek, he is advising startups, sitting on industry boards, speaking nationally on combination product and connectivity issues and serving as a Graduate Professor at Loyola Marymount University. LinkedIn: Steven Badelt, PhD

Nick Werner – Nicholas Werner has over 13 years of diverse experience within the medical device and life sciences industries.  He began his career serving as a Premarket Reviewer and a Postmarket Analyst with the US Food and Drug Administration before transitioning to working on total product lifecycle regulatory affairs for one of the largest medical device manufacturers in the country.  He has additionally provided a broad range of services to clients, including EU MDR assessments and remediation, regulatory submission preparation and review, and regulatory strategy.  His unique background allows him to approach regulatory issues from the perspectives of both industry and health authorities. LinkedIn: Nicholas Werner