In the News

Today, Congressman Gerry Connolly (D-VA) introduced the Opioid Immediate Suspension Order Act, legislation that would help restore the ability of the Department of Justice to respond to the growing opioid crisis.

“Nearly 200,000 people have died from opioid prescription overdoses since 2000,” said Congressman Gerry Connolly. “This crisis demands immediate action. The Opioid Immediate Suspension Order Act will help restore one of the most effective tools the Department of Justice had in stemming the most egregious distribution abuses.”

“Now is not the time to tie DEA’s hands,” Connolly added. “We need to hold everyone along the supply chain accountable, from the pharmaceutical distributors, to the pharmacies, to the prescribers.”

A Washington Post/CBS 60 Minutes investigation this weekend detailed the resulting fallout of the Ensuring Patient Access and Effective Drug Enforcement Act of 2016. Prior to this law’s enactment, the DEA had the authority to suspend a pharmaceutical distributor’s license if the Attorney General, based on longstanding agency practice, found there was an imminent danger to the public health and safety. This authority has traditionally been used to stop suspicious shipments of prescription drugs. For example, one pharmacy in West Virginia received more than 258,000 pills in one month, ten times the typical average. The DEA's traditional use of immediate suspension orders can help combat such abuses.

The 2016 legislation, however, raised the threshold the DEA must meet to exercise this authority by defining imminent danger as: 

·         21 USC 823 (d)(2) "imminent danger to the public health or safety" means that, due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this subchapter or subchapter II, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration.

Connolly’s legislation would rescind that limited definition and provide DEA additional authority to suspend distributor’s license. In detailing concerns with the current implementation of the “imminent danger” definition, Chief Administrative Law Judge John J. Mulrooney wrote: “It is equally remarkable that, notwithstanding the death of court review of this public-safety tool, or any other readily apparent reason, Congress determined that the “imminent danger to public health and safety” standard required a statutory definition that imposed a dramatic diminution of the Agency’s authority to issue Immediate Suspension Orders at a time when, by all accounts, opioid abuse, addiction, and deaths were increasing markedly.”

Connolly’s legislation is available here.