Technology Helping FDA Screen for Illegal Drugs
FDA commissioner Scott Gottlieb and two colleagues say the agency is using new screening technology at international mail facilities (IMFs) to enable it to screen more packages to prevent illegal products with hidden drug ingredients from entering the U.S. Writing in an FDA Voice blog post, the three say that the volume of mail entering the IMFs and the increasing sophistication of criminals make it a challenge for FDA to keep up.
They write that last year the agency increased the number of investigators posted in IMFs from eight to 22 full-time employees, increasing the number of packages they are able to open and screen from 10,000 a year to 40,000. These are packages that Customs and Border Patrol has flagged for additional screening to intercept and detail what are believed to be nefarious products prior to refusal of admission and possible destruction, the post says.
The FDAers say one of the most promising technical developments is the successful use of various portable screening devices that will allow the agency to rapidly test for unsafe ingredients at the IMFs with similar reliability and accuracy as the current laboratory methods.
A successful six-month pilot at two IMFs used an ion mobility spectrometer that compares the chemical signature of an unknown substance against the chemical signatures of known compounds in less than 30 seconds.
The pilot used the device with a custom-built library of drug compounds to test whether products marketed for weight loss and sexual enhancement contained undeclared drug compounds such as sibutramine, phenolphthalein, and sildenafil, which have significant safety concerns and are often counterfeited. “An astonishing 65% of the samples we screened tested positive for the presence of undeclared pharmaceutical products, results that were confirmed in an FDA laboratory,” the post says. “Based on these results, we’re able to demonstrate that the device was reliable, efficient, and produced valid results. As a result of this pilot, we’ve decided to expand the use of this new technology and add devices at two additional IMFs. Our aim is to refine our use of this device and eventually install it at all nine of our IMF facilities so that our staff can more quickly determine whether products contain undeclared drug ingredients.”