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FMG Law Blog Line

FDA Approves First Drug Made by 3D Printing

Posted on: September 1st, 2015

By: Mike Bruyere

Additive manufacturing, or 3D printing, reached a significant milestone this month when the FDA approved the production of an epilepsy medication that will be marketed under the name Spritam.  The new drug, developed by Aprecia, controls seizures brought on by epilepsy, and is the first drug produced by a 3D printer to receive the FDA’s imprimatur.

3D printing was invented over thirty years ago by a brilliant engineer, Chuck Hull. At its most fundamental level, 3D printing began as the modification of an ink printer to utilize various materials as the “ink” or powder to build vertical levels of a design. In successive passes of the build process, the printing jet is slightly raised and the printed material is added onto the previous layers.

3D printing enables medical providers to rapidly produce devices like customized artificial limbs, dental devices, and exterior bracing (such as braces used to treat scoliosis).  Accordingly, the availability of high-quality and low-cost devices is spreading geographically and throughout the health care industry. 3D printing applications are currently in use or development for pumps, stents, coils, surgical guides and a host of orthopedic applications.

As with myriad other applications in the life sciences industry, 3D printing of medicines brings the manufacturing process much closer to the patient, but it also raises potential issues concerning who is considered the actual manufacturer of the drug from a products liability standpoint.  For example, is Aprecia considered the manufacturer, or are other entities involved in the design, testing, manufacturing (such as the manufacture of the 3D printer), and distribution of the drug also at risk?  Additionally, while life sciences advances such as Spritam hold the promise of lower health care costs and more readily available drugs, the implications for misuse of this technology, particularly in the area of illegal designer drugs, cannot be understated.

 

 

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