Gottlieb’s post was titled “FDA is Using Innovative Methods to Prevent Illegal Products with Hidden Drug Ingredients from Entering the United States.” In it he detailed the methods the agency is employing to monitor the flood of products entering the country every day.
Daunting scale of issue
First, Gottlieb laid out the scope of the issue. The volume of material processed by International Mail Facilities (IMF) is rising at an exponential rate.
“According to a January 2018 report by the US Senate Permanent Subcommittee on Investigations, 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,” Gottlieb wrote.
Since many of these packages come with no identifying information, Gottlieb said there is no way to know how many of these contain products regulated by FDA.
“What we do know is that every year thousands of packages are found to contain FDA-regulated products and a surprising percentage of those products are illegal...They include unapproved products; counterfeit or substandard drugs; and purported dietary supplements being sold for weight loss, sexual enhancement, bodybuilding or pain relief,” he wrote.
Added headcount
Gottlieb noted that FDA has added inspectors, bringing the staff devoted to IMF screenings up to 22 from 8. That means 40,000 packages can now be inspected annually, up from 10,000. This still means, however, that only an estimated 0.06% of packages can be physically inspected.
While that might appear at first glance to be absurdly low, it doesn’t seem as paltry when compared with the rate at which federal income tax returns are audited. About 0.5% of federal tax returns are audited in those income brackets where about 85% of American find themselves (reporting more than $1 and less than $100,000 in taxable income, that is). And after all, collecting income tax is a revenue generator, not a cost center, for the federal government.
Technology to the rescue
Still, more must be done, Gottlieb agreed. Documenting the contents of a package can take from 20 minutes for the simplest cases, to much more time for packages that contain multiple products. Getting lab results back can take weeks. To speed up the process, FDA is deploying hand held technology similar to what is used to screen for explosives at airports.
A pilot test of a handheld device, loaded with a library of chemical signatures from typical pharmaceutical adulterants, was successful at two IMFs, Gottlieb said. More devices will be added at two more IMFs, with the plan to eventually have such devices in place at all nine facilities. In the test run the device found that 65% of the packages flagged for inspection contained one or more of the illicit ingredients.
More vigilance applauded, but more enforcement is called for, too
Steve Mister, CEO and president of the Council for Responsible Nutrition, said the increased vigilance is welcome. Mister said CRN has advocated for additional resources to be devoted to the issue for some time.
“If FDA is serious about tackling the problem of tainted products containing illegal drug ingredients, the agency should use the intelligence it gathered to follow through on its allegations with enforcement. We encourage the agency to issue recalls and import alerts so that business partners and recipients of these ingredients here in the US can be on alert to discontinue their affiliations with potentially nefarious sources or to implement heightened testing of incoming ingredients,” Mister said.
“We also urge the agency to make public the identities of the perpetrators and to refer them for enforcement by the Department of Justice. Bad actors deserve public scrutiny and criminal prosecution, and FDA has the authority to take these actions,” he added.
“The responsible industry has voiced innumerable times its suspicion of tainted products being manufactured overseas and entering the US via our ports. Thus, we are pleased FDA has heard our concerns, and we are committed to support the agency’s efforts to increase consumer safety through the prevention of illegal products from entering the marketplace,” Mister added.
What about illicit IP?
Attorney Marc Ullman, at counsel with the firm Rivkin Radler, said that along with the increased vigilance of products containing illegal ingredients, it would behoove FDA to address the issue of products containing ‘borrowed’ (one might say, ‘stolen’) intellectual property. Ullman said in the current climate companies are dissuaded from going through the trouble of filing a New Dietary Ingredient Notification on their ingredient when me-too products can proliferate with the same ingredient without much fear of repercussions.
“There are various issues floating around the agency, such as a general lack of respect for intellectual property,” Ullman said.