Sessions Pressures Drug Companies With Quotas to Stop Opioid ‘Pill Dumping’
Posted April 17, 2018 5:41 p.m. EDT
WASHINGTON — Attorney General Jeff Sessions proposed regulations Tuesday that could severely limit the amount of highly addictive opioid pain medication that drug companies can produce and force them to account for scores of illegitimate prescriptions across the country.
The regulations would change how the Drug Enforcement Administration sets production quotas for drug companies. Those companies would have to work with states, the Centers for Disease Control and Prevention and other federal and state agencies to justify the number of pills they send to medical providers.
“Under this proposed new rule, if DEA believes that a company’s opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make,” Sessions said at an appearance in Raleigh, North Carolina, according to prepared remarks.
The proposal would allow Sessions to put pressure on the powerful pharmaceutical industry without punishing it for the opioid crisis, which in 2016 contributed to more than 42,000 deaths in the United States, according to the CDC. While the change would allow the drug agency to more actively track where pharmaceutical companies send their products, a 2016 law hamstrings the ability of the agency, which is part of the Department of Justice, to stop shipments.
“No one’s trying to revise the law that limited DOJ’s and DEA’s ability to go after drug distributors,” said Regina LaBelle, a former chief of staff at the White House Office of National Drug Control Policy. “Essentially, people have looked at the quota system as being part of the problem for many years. And this announcement and new rule would appear to be trying to address that issue.”
The announcement was spurred by a lawsuit filed by the attorney general of West Virginia, Patrick Morrisey, who accused the Drug Enforcement Administration of allowing drug companies to create their own quotas for pill manufacturing, without justifying where those pills were going.
The Trump administration has taken a multipronged approach to countering the opioid epidemic, targeting traffickers and the clinics that supply them in enforcement operations. In January, Sessions announced that federal law enforcement would focus on pharmacies and prescribers that doled out a disproportionate number of prescriptions for the highly addictive pain medications.
That effort, according to the drug agency, netted 28 arrests and resulted in 147 revoked registrations for prescribers.
“I heartily applaud Attorney General Sessions for the major step he is taking and for his continued collaboration with our office to protect West Virginians from this deadly scourge of opioid excess,” Morrisey said of the proposed change. “I am also appreciative of President Trump’s dedication to addressing the opioid problem, as it represents such a stark departure from the past.”
The phenomenon of “pill dumping” — drug companies’ sending exorbitant amounts of prescription opioids to medical professionals who then farm them out to vulnerable communities — has ravaged West Virginia. The state had the most opioid-related deaths in the country in 2016, according to the Centers for Disease Control and Prevention.
A House Energy and Commerce investigation into the matter revealed that from 2006 to 2016, drug companies sent more than 20 million prescription opioid pills to two pharmacies in the West Virginia town of Williamson, where about 3,000 people live.
Sessions’ proposed change must still go through the federal rule-making process before going into effect. It will be published in the Federal Register and opened to public comment.
A bill proposed by Sen. Joe Manchin, D-W.Va., would reinstate the drug agency’s ability to interdict suspicious pill shipments and more quickly stop drug companies from sending them. Those authorities were stripped from the agency in a 2016 law supported by the drug industry. Manchin’s bill remains in the Senate Judiciary Committee.