The FDA’s approval of the first 3D-printed drug could lead to complicated product liability and intellectual property issues, attorneys told Bloomberg BNA recently.
The 3D printing of drugs products could lead to problems with identifying the patented drug product and with identifying who is considered the manufacturer for product liability purposes, the attorneys said.
In August, the Food and Drug Administration approved Aprecia Pharmaceuticals Co.’s 3D-printed drug Spritam (levetiracetam) for oral use as a prescription adjunctive therapy in treating partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy (13 PLIR 1146, 8/7/15).
Spritam uses Aprecia’s proprietary ZipDose Technology platform, which uses 3D printing to produce a porous formulation that rapidly disintegrates with a sip of liquid.
Aprecia said its 3D printing technology platform is proprietary and not available to the general public, so no one will be able to use the technology to print drugs at home, in hospitals or in pharmacies.Read more
Source: bna.com; image: qz.com