prescription drug abuse

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Dear President Trump,

For several years the prescription drug epidemic has ravaged communities across the United States. During that time, the Drug Enforcement Administration (“DEA”) has aggressively pursued enforcement actions against the regulated industry. Despite admirable efforts to curtail the epidemic through enforcement actions, prescription drug abuse continues to be a public health crisis. There have been many solutions put forth in the past several months. These solutions, while well-intended, failed to address the root causes of the epidemic – overprescribing of controlled substances. Mr. President, this is a unique opportunity for you to reset our approach to this crisis. As a first step, we need to reassess the enforcement-first approach of the past several years.

Pills and bottle

Nobody would argue with the fact that there is an opioid crisis in our country – it is a demonstrable fact. However, there has recently been a significant focus on whether drug wholesalers and their business partners including lobbyists have caused people to die from overdoses, including a recent segment by 60 Minutes. While the segment sought to educate viewers on the causes of prescription drug abuse and the alleged slowdown in enforcement efforts by the government, it is of course journalism and takes a strong position against drug companies. Aided by reporters from the Washington Post and former employees from the Drug Enforcement Administration (“DEA”), the 60 Minutes segment, while dramatic in its presentation, only told the facts relevant to the position it was taking – which is what makes good headlines.

The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month.  The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt their reporting for West Virginia.

On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications for DEA-registered wholesalers, who are required to detect and report suspicious orders of controlled substances.

An Oklahoma doctor wrote 19 Schedule II controlled substance prescriptions for a patient with low back pain over eight months without thoroughly documenting the patient’s history, confronting the patient over aberrant drug tests, or talking to other doctors who were prescribing the patient controlled substances. The Chief Administrative Law Judge felt the doctor should be granted a new registration, but placed on probation for one year. Acting Administrator Chuck Rosenberg disagreed. He reviewed the case and concluded that DEA proved that the doctor knew the patient was abusing or diverting the drugs and prescribed anyway.  Dr. Wesley Pope’s application for a new DEA registration was denied as inconsistent with the public interest.

On July 27, 2015, the Government Accountability Office (GAO) released a report titled, Prescription Drugs: More DEA Information about Registrants’ Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access.  GAO’s report examined, (1) to what extent registrants interact with DEA about their CSA responsibilities, and registrants’ perspectives on those interactions, (2) how state…

drugs

On September 23, 2014, DEA announced that its ninth Take Back Day would be the agency’s last.  The announcement was made shortly after DEA published the Final Rule implementing the Secure and Responsible Drug Disposal Act of 2010.  The regulations promulgated by DEA allow “authorized collectors” the opportunity to receive and securely dispose of prescription…

DEA-HandcuffsOn May 20, 2015, DEA issued a press release regarding a recent major enforcement action in Arkansas, Alabama, Louisiana, and Mississippi. Operation Pilluted targeted alleged pill mills that were engaged in the illegal distribution of oxycodone, hydrocodone and Xanax. The operation resulted in the arrest of 280 individuals, including 22 doctors and pharmacists. Executing 21…