FDA lays groundwork for regulating 3D-printed drugs
- The Food and Drug Administration has issued guidance on 3D printing and the role it plays in manufacturing healthcare products.
- While the guidance focuses largely on medical devices, Commissioner Scott Gottlieb acknowledged in a Monday statement that the innovative technology also holds the potential to disrupt drug development. Already, the agency has approved one medicine crafted with 3D printers, Aprecia Pharmaceutical Co.’s Spritam.
- "This is likely just the tip of the iceberg given the exponential growth of innovative research in this field," Gottlieb said, referring to the 3D-printed products on the market. "We envision that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs."
The pharmaceutical industry tends to attract disruptive technology, as drug and device makers look to make therapeutic advances. But manufacturing — at least for the medicines themselves — has largely stuck to its tried-and-true ways, moving more slowly to incorporate new techniques.
The promise of 3D printing, however, could spark new innovation and invention in how drugs, and the devices that deliver them, are formulated and made. In response, the FDA is moving to stay ahead of the technology's advances.
3D printing has been on healthcare providers’ radar for years, though more so for medical device manufacturing than medicine making. There are more than 100 FDA-reviewed medical devices on the market that were crafted with 3D printing, including materials used knee replacements and facial reconstruction, according to Gottlieb.
Meanwhile, the FDA approved its first 3D-printed drug in the back half of 2015. Aprecia's Spritam (levetiracetam) is indicated as an adjunctive therapy for a trio of seizure types — partial onset, myoclonic and primary generalized tonic-clonic — in adults and children with epilepsy.
The FDA's new guidance offers guidelines and suggestions on many of the factors medical manufactures must consider when developing a 3-D printed product, such as how to document specifications for the raw materials that go into a device or how that device's shape and fit affect medical imaging. The agency noted, however, that this is "leap-frog" guidance, because regulators will surely make the jump to more formal recommendations as 3D printing's application to healthcare becomes better understood.
"These steps are part of our broader effort to help ensure our regulatory framework is properly matched to the unique attributes of the new technologies we’re being asked to review. 3D printing is certain to alter the daily practice of medicine where patients will be treated with medical products manufactured specifically for them," Gottlieb said.
While the industry awaits that more concrete guidance, the FDA is exploring the technology on its own. Agency scientists can study 3D printing's impact on inactive pharmaceutical ingredients and quality control in manufacturing at the Center for Drug Evaluation and Research. And in the Center for Devices and Radiological Health, others are investigating how design changes influence the safety and efficacy of 3D-printed devices.
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