FDA pushes for authority to destroy unlabeled drugs in mail

Food and Drug Administration Commissioner Scott Gottlieb urged Congress on Wednesday to let his agency destroy unlabeled drugs found in the mail, saying officials are seeing traffickers try to sneak illegal shipments through from overseas.

Customs officers turn suspected drug packages over to the FDA which, if it can’t verify the bona fides of a shipment, usually has to return it to the sender — who often will just put it right back in the mail, hoping to succeed the next time.

Dr. Gottlieb said if his inspectors were allowed to destroy mislabeled or otherwise suspect drug shipments, they could break the cycle.

“It’s not uncommon for our investigators to see the same package again and again as shippers resend the same boxes a second or even third time,” Dr. Gottlieb told the House Energy and Commerce Committee. “This process is not a deterrent.”

His testimony came as the House prepares to move forward with a package of bills to combat the opioid epidemic.

Rep. Frank Pallone, New Jersey Democrat, has offered legislation that would authorize the FDA to destroy drugs that are “misbranded, unlabeled or minimally labeled” and appear either to contain active drug ingredients or an “article of concern” such as new versions of the opioid fentanyl that haven’t yet made federal banned lists.

Rep. Marsha Blackburn, Tennessee Republican, is also pushing legislation that give the FDA new resources to screen more packages. Right now only a fraction are checked.

Other measures would speed the approval of painkilling alternatives or link ER patients with treatment after they overdose.

The House panel will also consider legislation to let doctors know if patients have a history of addiction, study how many teens are using injectable drugs, and boost efforts to interdict fentanyl, the powerful synthetic opioid blamed for the recent spike in overdose deaths.

All told, some 25 bills will be on the calendar during hearings this week.

“That is a large number, but the crisis demands that we provide the attention necessary,” said Rep. Michael C. Burgess, Texas Republican.

Mr. Pallone also said Congress must approve a massive spending bill now before both chambers in order to unlock some $6 billion in anti-opioid money. Otherwise, he said, the bills under consideration “are nothing more than empty words.”

Opioid-related overdoses killed 42,000 people in 2016 and the 2017 figures are expected to be even worse, driven by the surge in deadly fentanyl from clandestine labs overseas.

The federal government is grappling with how to keep those drugs out.

President Trump argues that a wall along the southern U.S. border would help, while Republican Sen. Rob Portman of Ohio wants to require foreign mail services to send electronic data in advance of packages transmitted to the U.S. Postal Service.

Private couriers like UPS and FedEx always send advance data, helping U.S. Customs and Border Protection root out illicit parcels, though foreign postal services have been slow to adopt the measure.

Mr. Portman wants to mandate the data through his bipartisan bill, the STOP Act, though the bill is still pending in committee.

It’s a thorny issue, because if other countries didn’t comply with new standards, the U.S. mail could be forced to reject packages from noncompliant countries altogether.

Dr. Gottlieb said his own inspectors could use advance data, since it’s only able to examine a fraction of the millions of packages that enter international mail facilities and may contain drugs.

“As the sophistication of those trying to penetrate our mail facilities continues to increase, this represents a growing vulnerability,” he said.