FDA Commissioner Scott Gottlieb confirmed in a mostly secret summit on online opioid sales that his agency is not just targeting illicit trade in addictive painkillers, but stepping up enforcement aimed at other sorts of FDA-regulated products purchased on the internet.
Although Gottlieb did not specify those other products, Tarbell reported earlier this month that the FDA is dramatically ramping up interdictions of cheaper regular prescription drugs that Americans order online from overseas pharmacies.
Gottlieb cast the heightened enforcement primarily as targeting opioids, however, pointing last Wednesday to a recent FDA operation against nine online networks that allegedly offered the drugs.
“We need to give the criminal purveyors of these products no quarter,” Gottlieb said. “I don’t want to be caught again feeling like we’re one step behind a dangerous new turn in this crisis. And that’s why we’re going to hit back hard.”
Online opioid sales, however, account for only a small part of a crisis that the Centers for Disease Control and Prevention estimate claimed 42,249 lives in 2016. According to a 2017 study by the Substance Abuse and Mental Health Services Administration, only 0.1 percent of people aged 12 and up got their pain pills over the internet. The Internet Association — which attended the summit — told reporters in a conference call that data shows just 3.4 percent of people who abuse opioids get them online.
At the same time, while Gottlieb noted that the opioid crisis is evolving, it still has its roots in the over-prescribing of drugs legally manufactured and sold by the pharmaceutical industry. A recent CDC study found that doctors prescribe more than three times as many opioids as they did in 2000. Indeed, in 2015 it was enough to medicate the entire U.S. population 24 hours a day for three weeks straight.
According to Gottlieb, the vast majority of the FDA’s investigations still target non-opioids. Citing new statistics, he said that of 339 probes at U.S. ports of entry in 2017 by the FDA’s Office of Criminal Investigation, 19 involved opioids. This year, with 167 investigations launched so far, 25 involve opioids.
The point of the summit was to put pressure on tech and banking companies to do more to make it harder to run illicit opioid operations online. But Gottlieb also made clear the investigation unit was not just focusing on opioids.
“OCI’s current investigations include the counterfeiting and illicit manufacturing of opioid products and other illicit pharmaceuticals being distributed on the surface web, as well as on the dark web,” Gottlieb said.
And he pledged that increased funding from Congress — including $94 million passed in March — would go to all the areas the FDA polices, not just the minority of cases involving opioids.
“We’ll use these new resources to interdict more illegal products flowing across our borders, including products ordered online, as well as shifting more of our criminal investigative resources to target these online sales,” Gottlieb said. “This is a conscious policy decision by the FDA, and we believe these online sales represent one of the highest areas of risk facing Americans right now.”
Most of the summit had originally been billed as being open to the public through a webcast. But reporters were excluded from the event and the agenda was revised shorty beforehand to stream only remarks by FDA officials.
Gottlieb said the discussions were closed in the interests of security and fostering an open dialogue among the participants, which included Google, Oath’s Yahoo, Microsoft’s Bing, Twitter, Facebook and others.
Many of the tech company participants are members of an organization called the Center for Safe Internet Pharmacies, which was created by the pharmaceutical industry in collaboration with the Obama administration to crack down on attempts to use the internet to import prescription drugs from overseas.
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The industry has long opposed such imports, which could cut into their bottom lines, on safety grounds. The rationale used to create CSIP was also centered on protecting Americans, except it was focused on regular prescription drugs before the opioid crisis.
A number of organizations funded and created by the pharmaceutical industry also attended the summit, including the Alliance for Safe Online Pharmacies, which helped create CSIP.
The high level of secrecy appears to have stemmed from the tech companies’ concerns. Given a chance by Gottlieb to ask questions in one of the brief open portions, none of the dozens of representatives in the room took him up on the offer.
The FDA has yet to release its conclusions from the summit.