New law makes DEA’s job ‘harder,’ former officials say
A new law supported by opioid distributors and manufacturers is making it increasingly difficult to hold companies accountable when they run afoul of the nation’s drug laws, according to recently retired Drug Enforcement Administration investigators on the front lines of the war against opioids.
They join a chorus of voices calling for changes to the law that includes Attorney General Jeff Sessions, 44 state attorneys general and the head of the DEA office that regulates pharmaceuticals.
The field investigators said the new law is hurting efforts to halt suspicious shipments of prescription pain pills and slowing the agency’s investigative efforts. Morale within the ranks of the DEA’s field divisions has plummeted, they said in interviews with
The Washington Post and 60 Minutes for a joint investigation. “The law makes it much harder for us to do our jobs,” said James Rafalski, a DEA investigator who retired in June after a 39-year career in law enforcement, the last 13 years with the agency.
The Ensuring Patient Access and Effective Drug Enforcement Act of 2016 was pushed through Congress by a small band of lawmakers backed by a powerful array of drug companies. The law has undermined the DEA’s most potent tools in the war against the opioid epidemic, according to agency investigators, agents, lawyers and the DEA’s chief administrative law judge.
The law was sponsored by Rep. Tom Marino, R-Pa., in the House. Sen. Orrin G. Hatch, R-Utah, negotiated a final version with the DEA in the Senate.
After the October report, Marino withdrew his nomination to become drug czar, which would have put him in charge of the White House Office of National Drug Control Policy. Attorney General Sessions said that he was “dubious” about the law when he was a senator and has since come the conclusion that it should be changed. Forty-four state attorneys general, as well as Democratic lawmakers in Congress, have called for its repeal.
During a Senate Judiciary Committee hearing Tuesday, the head of the DEA office that regulates the pharmaceutical industry said the law has made enforcement more difficult in urgent circumstances and should be revised.
The Post has previously reported that DEA enforcement actions began dropping in 2013 after agency attorneys began requiring higher standards of proof to bring cases, as the DEA pursued a path of greater cooperation with industry.
DEA investigators and agents said in recent interviews with The Post and 60 Minutes that the law has further hobbled their efforts at the height of the prescription opioid epidemic.
Previously, the agency had broad authority to freeze drug shipments that posed an “imminent danger” to the community in an action called an immediate suspension. Under the new law, the DEA must demonstrate that a company’s actions represent “a substantial likelihood of an immediate threat,” a much higher bar. The law also allows companies to submit “corrective action plans” before the DEA can sanction them.
“This Marino-Hatch bill is outrageous,” said Jim Geldhof, a DEA program manager who retired in 2015 after 43 years with the DEA. “It basically takes any kind of action DEA was going to do with a distributor or manufacturer as far as an immediate suspension off the table.”
Supporters of the new law defend it as a means of protecting patients while not damaging the DEA.
“This was an effort to ensure that DEA’s praiseworthy efforts to stem abuse don’t end up hurting legitimate patients,” Hatch said during Tuesday’s Senate hearing.