A report from Regulatory Focus describes how the House Energy & Commerce Committee is examining rule changes that will allow inspectors to seize and destroy suspected counterfeit medication and other illicit substances at international mail facilities (IMF).
In the FDA Voice blog from March 21, FDA Commissioner Scott Gottlieb and others note that “in just three years from 2013 to 2015, the number of packages processed by the nation’s nine IMFs nearly doubled. Today, these combined facilities receive more than 275 million packages a year. Most of the mail arrives without advanced or specific identifying information. As a consequence, we have no way of knowing exactly how many packages contain FDA-regulated products.”
The FDA Voice describes the incredible range of illicit products that come through our borders including counterfeit or substandard drugs, and dietary supplements that have allegedly been produced to address weight loss, sexual enhancement, and bodybuilding.
The challenge that FDA and border control inspectors currently face, according to Commissioner Gottlieb, is that before authorities can seize and destroy packages, they must first document the contents of both the packages and pills they contain, which is incredibly time-consuming. Gottlieb notes that “screening a single package can take about 20 minutes.”
Regulatory Focus points out that FDA is hoping to revert to 2006 rules wherein the FDA did not have to go through a judicial process before seizing and destroying questionable packages. As it stands any questionable package that cannot be sufficiently screened is simply sent on to the recipient.
“The more that FDA can improve the efficiency of its process, its authorities, and the tools that it uses to evaluate products; the more higher-risk packages that the agency is able to subject to vetting,” said Gottlieb in the FDA Voice blog.