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.

Recently, the Oregon Board of Pharmacy adopted a new rule for wholesale distributors, requiring that they report suspicious orders to the Board for review. The rule goes into effect on July 1, 2017.

The adoption of the new rule followed several recent settlements by wholesale distributors around the country, who are facing severe penalties for failing to report suspicious orders of controlled substances to the Drug Enforcement Administration (DEA).

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DEA recently announced a significant change to its registration renewal process.

For several years, DEA’s registration unit has allowed for a grace period for registrants who file an untimely application for renewal.  While DEA’s regulations do not contemplate such a grace period, registrants, especially individual practitioners, were allowed to keep their existing registration number — which was considered valid and active during the grace period — despite the failure to file a timely renewal application and despite multiple notifications from DEA.

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

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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

57339493On May 5, 2015, the United States Senate, Caucus on International Narcotics Control held a hearing exploring the findings and recommendations of a Government Accountability Office investigation into the Drug Enforcement Administration’s management of its quota process.  The hearing, called by Senators Grassley and Feinstein, sought to explore the connection between DEA’s quota process and

cap1As we previously reported, on February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015.  Also on that date, the Senators introduced legislation that would also amend the Controlled Substances Act, as well as the Food, Drug, and Cosmetic Act.  This legislation addresses, among other things,