Novel encapsulation technology for oral delivery
Freund Pharmatec
The US Food and Drug Administration has launched an offensive against counterfeit pharmaceuticals after seeing an increase in both the number of cases and the ability of counterfeiters to get their products into legitimate distribution channels.
The agency stressed that the practice is not widespread, but it is now investigating around 20 cases a year, compared to an average of just five a year in the late 1990s.
The initiative includes the creation of an internal agency task force to explore the use of modern technologies, plus other measures, such as stronger enforcement, to make it harder to distribute counterfeit drugs. The task force will submit its initial findings and recommendations in 60 days and issue a final report in six months, after public comment.
Technologies under review include counterfeit-resistant packaging, product identifiers such as chemical tags and implanted radio-frequency chips in packaging to help assure the authenticity of drugs. Some of this technology is not mature enough to adequately protect the drug supply, according to the FDA, but it may have great promise as an added counter-measure.
"The sole purpose of this initiative is to develop new and innovative ways to make sure Americans can continue to have confidence that the drugs they buy are, in fact, the real deal," noted FDA Commissioner Mark McClellan.
