Alaska has joined 43 state and territorial attorneys general seeking a repeal of federal legislation they contend took away an important tool in combating the nation’s opioid crisis.
The Ensuring Patient Access and Effective Drug Enforcement Act of 2016, signed into law on April 19, 2016 by President Obama, contained language that prohibited the attorneys general contend prohibited the Drug Enforcement Administration from immediately suspending a drug manufacturer or distributor who posed an immediate danger to public health or safety.
“What the 2016 law effectively did was remove the ability to hold drug manufacturers and distributors accountable for their actions,” said Alaska Attorney General Jahna Lindemuth.
The lawsuit alleges deceptive marketing and promotion activities that have led to providers over-prescribing the opioid, they contend.
More than two million people had an addiction to prescription or illicit opioids in 2016, and in Alaska, between 2009 nationwide and 2015, 774 drug-overdose deaths were recorded, according to the Alaska Department of Health and Social Services. Of those deaths, 512 had a prescription drug noted as either the primary or contributing cause of death.
The attorneys general said in a Nov. 13 letter to congressional leaders the legislation was a step backward in their collective effort to prevent the diversion and misuse of prescription drugs and address a worsening epidemic of opioid addiction and overdose deaths.
The legislation added language to federal law redefining “imminent danger to the health or public safety” to mean a “substantial likelihood of an immediate threat of death, serious bodily harm, or abuse of a controlled substance.”
According to SEA Chief Administrative Law Judge John J. Mulrooney II, the language has created an exceedingly high burden that is nearly impossible to meet, the attorneys general said. As a result, the DEA’s ability to immediately suspend a registrant and institute simultaneous show cause proceedings against a manufacturer or distributor whose unlawful behavior endangers public health or safety is severely diminished, they said.
