FDA Seeks Changes to Authorities at International Mail Facilities

Regulatory NewsRegulatory News
| 21 March 2018 | By Zachary Brennan 

As part of a two-day House Energy & Commerce hearing looking at about two dozen different bills to address the US opioid epidemic, Scott Gottlieb, commissioner of the US Food and Drug Administration (FDA), told representatives that FDA needs more authority to seize and destroy suspect packages, some of which contain illegally distributed and manufactured opioids.

Although FDA has increased the number of investigators it has in international mail facilities (IMFs) from 8 to 22 full-time employees, it’s estimated that FDA can only physically inspect less than 0.06% of the packages that might contain drug products.

One of the issues Gottlieb explained during the hearing is that when labels on such packages are stripped away, the packages cannot be destroyed and must be returned to their senders because FDA cannot establish the intended uses of such packages. But Gottlieb noted that oftentimes, IMFs see these packages return a second or third time.

He also noted that FDA’s employees at IMFs are seeing more and more small packages, and if a sender tries to distribute a bulk package with thousands of smaller boxes contained inside, FDA has to initiate a proceeding against each of the smaller boxes to destroy them, and only if the agency can establish that the drugs are misbranded.

As far as changes to FDA’s seizure policies, Gottlieb called on representatives to revert to how FDA operated prior to 2006 when the agency did not have to go through a judicial process to establish probable cause before intercepting and destroying such packages.

Such changes to FDA’s ability to seize and destroy products at IMFs could help to stop the introduction of illegal opioids and other drugs that might harm Americans.

According to a January 2018 report by the US Senate Permanent Subcommittee on Investigations, from 2013 to 2015, the number of packages processed by the nation’s nine IMFs nearly doubled, and the facilities now receive more than 275 million packages annually. But FDA said they have no way of knowing exactly how many packages contain FDA-regulated products.

“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,” Gottlieb and other FDA officials wrote in a blog post published Wednesday.

More on FDA’s work at IMFs

House E&C Hearing


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