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August 19, 2015 Practice Points

A New Era: 3D Printed Medical Drugs

By Corey Lorenz

The pharmaceutical industry has officially entered a new era. Early this month, the FDA approved its first 3D printed medical drug. In doing so, it opened the door to a new realm of possibilities for product development and changes to the landscape of products liability law.

In basic terms, 3D printing (also known as additive manufacturing) is the creation of three-dimensional objects from a digital file, essentially an electronic blueprint. Through this process, an object is created by adding layers of material until the object becomes whole. 3D printing has already been introduced to the FDA and the medical community, having been used, for example, to create prosthetics.

The first 3D printed medical drug to be approved by the FDA is called Spritam, sold by Aprecia Pharmaceuticals. Spritam is used to treat seizures in epilepsy patients, and is expected to hit the market in the first quarter of 2016. Spritam is a single ingredient drug, which is created by adding layers of the active ingredient through the 3D printing process. By using this layering process, higher, more precise doses can be used. Further, it creates a porous material that is quick dissolving, making it easier to swallow for patients. Essentially, the benefit is that by using 3D printing, Spritam offers a more efficient and effective delivery system.

This innovation is just the first step for the pharmaceutical industry. It is possible that in the future, 3D printing technology could enable the creation of customizable pills using multiple doses and ingredients. If this occurs, patients might only need to take, and create, a single pill truly customized to their medical needs. Additionally, doctors may be capable of adjusting dosages even more specifically for their patients, eliminating a need for the uniformity of each drug. It is not difficult to envision a time when a pharmacy, or even a patient, will become capable of printing medications themselves.

Though we are not there yet, and it likely will be many years, it is easy to see that the relevant issues in products liability law may be subject to change in the future. Medical drugs may no longer be uniform, and identifying who a "manufacturer" is will likely become a significantly more complex question. It will be interesting to see how this technology evolves and how it changes the pharmaceutical industry over time.

Keywords: products liability, litigation, FDA; 3D printing; pharmaceutical; medical drug; products liability

Corey Lorenz is with Wexler Wallace LLP in Chicago, Illinois.

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