The FDA’s Office of Criminal Investigations, which tracks down foreign-imported, mislabeled drugs, protects pharma companies as much as it protects consumers, critics argue. And some agents say one drugmaker in particular gets a disproportionate amount of their time and energy.
FDA agents have turned into the “Botox Police,” agency staffers told Reuters. They're going after every doctor who has purchased unauthorized versions of Allergan’s anti-wrinkle blockbuster, even those that were authentic, but labeled for use in other countries. And those hunts have often come at Allergan's own request, agents said.
In one field office, a psychologist heard complaints about "micromanagement" in general--and that Botox cases in particular squandered “valuable agent time”--documents reviewed by the news service show.
It’s an effort that’s incensed some agents, who refer to themselves as the “Allergan Task Force.” But there’s another problem, too: It’s an effort that doesn’t generate many prosecutions, despite an annual budget of $77.3 million.
The reason? Taxpayer-funded insurance programs don’t accept claims for Allergan’s star med unless it’s been prescribed for an approved medical purpose--meaning cosmetic uses are out. With Botox commonly used to fight wrinkles, finding unauthorized product doesn't necessarily lead to prosecution.
Allergan says it “shares the FDA’s position that consumer safety is the No. 1 priority, and strongly supports the FDA and its agents’ vigilance in ensuring safe, reliable pharmaceutical products for patients,” as a spokesman told FiercePharma in a statement.
But the majority of the Botox the OCI has seized has been found to be legitimate products made by the Dublin drugmaker, but labeled for use in other countries, 140 FDA lab reports reviewed by Reuters show.
Those factors considered, there’s little demonstrable damage to public health--or the pool of public dollars--from foreign Botox purchasing.
Another criticism of the Botox cases--from doctors caught up in the probes--is that they ultimately help Allergan protect its pricing scheme for the med.
“There is a reason why a doctor in the United States is incentivized to buy foreign-sourced Botox,” Fuerst Ittleman David & Joseph defense attorney Andrew Ittleman told Reuters. “All of this relates to … the lack of price controls and Allergan trying to control its market.”
That’s not to say the Botox investigations have been entirely fruitless when it comes to prosecutions. Allergan’s case referrals--including one against an unlicensed Virginia distributor hawking the treatment--have landed some convictions, Reuters notes.
But they're also helping feed an OCI “closed without action” rate of 53% between 2008 and 2015, the news service points out. The Environmental Protection Agency, for comparison, saw 71% of its opened cases produce criminal charges over that same period.
The FDA, though, disagrees with the use of statistics for measuring the OCI’s success. Protecting public health will “always trump the criminal investigation,” OCI director George Karavetsos told Reuters.
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