The U.S. Justice Department on Monday defended the decision by federal drug officials to temporarily suspend the ability of a Walgreens Co. drug distribution center in south Florida to fill certain controlled substance orders.
Attorneys for Walgreens, represented by a team from Latham & Watkins in Washington, are fighting the interim suspension order in a case pending in the U.S. Court of the Appeals for the D.C. Circuit. Walgreens' attorneys contend the Drug Enforcement Administration didn't follow its own rules when the agency, in September, issued the suspension order.
Yesterday, DOJ's legal team responded to the challenge, saying in a brief in the appeals court that the Walgreens distribution center in Jupiter demonstrated a "systematic failure to take the steps needed to ensure the safe distribution of controlled substance prescription drugs." DOJ's brief is here.
DOJ attorneys, including Samantha Chaifetz of the DOJ Civil Division, said the center failed to implement an "effective system for detecting suspicious orders and reporting them to the DEA." The government said the DEA decision to temporarily suspend the distribution center's registration stemmed from an "extraordinary increase" in oxycodone distribution. The data, according to DOJ, "was carefully examined in geographical and historical context."
Walgreens' lawyers at Latham & Watkins, including litigation partner Philip Perry, contend the suspension order violated DEA regulations and "relied on unreasonable and obsolete, year-old data" about increases in the shipment of oxycodone to Florida pharmacies.
"Had DEA properly considered the latest data from 2012, it could not have genuinely concluded that there was an 'imminent danger' to the public," the Latham attorneys said in court papers.
Much of the increase in demand for oxycodone, Walgreens' lawyers said, was "legitimate." That demand, according to Walgreens, flowed from changes in Florida law that prevented patients from receiving pain medication directly from doctors.
The attorneys for Walgreens said "DEA erred by assuming—without any statistical basis in the record or common sense—that all of this growth was due to illegitimate diversion."
The DEA last year initiated administrative proceedings to revoke the Jupiter distribution center's registration to fill orders for controlled substances. The DEA can terminate a registration if the agency administrator determines that it is "inconsistent with the public interest."