A bipartisan group of thirteen congressional representatives penned a letter to Administrator Michele Leonhart last week requesting “clarification, guidance and collaboration” about the Drug Enforcement Administration’s (“DEA’s”) efforts to combat prescription drug abuse. While voicing strong support of DEA’s efforts to fight prescription drug abuse, the letter states that recently “pharmacies across the country have identified a disturbing trend that is threatening the ability of legitimate patients from getting needed, lifesaving prescription drugs.” It states that small pharmacies have experienced difficulty obtaining certain controlled substances because wholesalers have severely limited or shut off sales. The representatives expressed concern “that inconsistent interpretation and application of DEA policies, and a lack of clear guidance and communication from DEA to supply chain stakeholders, are leading to patient care issues and supply chain disruption.”
The letter highlights the ongoing issues created by DEA’s failure to clearly define the requirements for identifying and reporting suspicious orders. Couple this with aggressive government enforcement and the result is that manufacturers and distributors have needed to be ultra-conservative in decisions on distributing controlled substances. It is understandable that the impact has been that certain pharmacies in certain areas of the country have had difficulty obtaining needed medicines. Rather than continuing to rely on ad hoc guidance, DEA should engage the industry in a negotiated rulemaking to establish clear and concise standards for suspicious orders to protect against diversion while ensuring legitimate DEA registrants are able to obtain the needed medicines.
Prescription drug abuse is this nation’s fastest growing drug problem and DEA has considered innovative methods to combat it. The expanded role of pharmacies, distributors and manufacturers as controlled substance gatekeepers is a continuously evolving one. As the lawmakers’ letter asserts, improved communication between DEA and pharmacies, distributors and manufacturers “will ensure that these stakeholders understand and perform their legal and ethical responsibilities and will result in less prescription drug abuse.” Clarification, guidance and collaboration, and administrative rulemaking addressing these issues will also help ensure that legitimate patients have access to needed medication.