Read part 1 here.
Where are we today?
Last month the FDA published a draft guidance document outlining principles of premarket pathways for combination products. The document lists 4 major types of combination products:
A “single entity” combination product (i.e. a pre-filled syringe or drug-eluting stent) comprising two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
A “co-packaged” combination product (i.e. a surgical or first-aid kit containing bandages and an antiseptic drug) comprising two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
A “cross-labelled” combination product (i.e. a light emitting device and a light-activated drug indicated for use together for treatment of a dermatologic condition) whereby a drug, device, or biological product packaged separately is intended for use only with an approved individually specified drug, device, or biological product and both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labelling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or
Any investigational drug, device, or biological product packaged separately that according to its proposed labelling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect (also a “cross-labelled” combination product).
The omission of any clear examples of digital health products is evident in these definitions. In addition, the FDA has kept the way combination products are being assigned and regulated internally effectively the same. Sponsors are advised to submit a single approval application depending on the product’s „primary mode of action“, i.e. whether it is drug-led, biologic-led or device-led, but a footnote indicates that multiple applications would generally remain a possibility for the constituent parts of cross-labelled products.
What does that say loud and clear?
Innovation acceleration continues to erode the traditional boundaries between drugs, devices and biologics. With the advent of the 4th industrial revolution, combination products no longer fit neatly into categories and regulatory frameworks established many decades ago. Rather than facing reality and working towards a solution that acknowledges the novelty of these products as a starting point and working from there, the FDA keeps trying to fit them into one if its three established centres, stretching the limits of definitions and overlooking the fact that combination products are more than the mere sum of their constituent parts.
As history demonstrates, unclear regulations often lead to unnecessary delays, which in turn hinder medtech pioneers from fully realising the potential of their inventions. By definition, the regulatory function of the FDA means it can never be as innovative and fast-adapting as the technology it oversees. However, it can definitely do a better job in keeping pace with emerging technologies and improving its structures to adequately address modern industry challenges.
Doing your own part
Until changes within the FDA eventually happen, combination product makers should anticipate scenarios involving multiple market approval pathways. Better awareness of the differences in safety and effectiveness requirements, approval times, application fees, product liability, etc. across different FDA sub-centres can help navigate regulatory labyrinths more easily and result in cheaper and faster market access.
In a recent statement, resigned FDA Commissioner Scott Gottlieb acknowledges that the agency’s current approach to novel tech regulation is hindering rather than fostering innovation. As clinicians and consumers increasingly embrace hybrid products, we keep a keen eye on the reforms the FDA undertakes to advance its practices and better align with the realities of today and tomorrow.
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