Prescription-drug abuse legislation signed into law

April 19, 2016
Pharmaceutical Commerce, Pharmaceutical Commerce - May/June 2016,

Ensuring Patient Access and Effective Drug Enforcement Act (S. 483) calls for better industry-government coordination

It took over two-and-a-half years, but the Ensuring Patient Access and Effective Drug Enforcement Act is now law, signed by President Obama on April 19. The law’s passage, besides being an exceptional example of bipartisan action by the highly polarized US Congress, is a feather in the cap of the Healthcare Distribution Management Assn., which has pushed for its passage for several years.

The very short law amends the Controlled Substances Act, which is the guiding influence for the Drug Enforcement Administration, to require DEA to assess the “substantial likelihood” of “immediate threat or death” before taking an enforcement action, and to allow for corrective actions to be taken when DEA suspects that controlled substances are being improperly distributed. A third section calls for a report to be issued a year from now on access to controlled substances, intergovernmental collaboration and state-level drug monitoring programs might be improved.

“Today’s enactment is a victory for not only supply chain stakeholders and regulators, who share a common goal in mitigating the scourge of prescription drug abuse in this country, but the many individuals who rely on life-enhancing pain medicines every day," said John Gray, HDMA president. "The changes brought forth through this law strike the appropriate balance of further protecting the supply chain against drug diversion, while allowing continuing patient access to critical medicines — and it does so in a way that promotes collaboration between the healthcare supply chain and those who regulate it."

For years, DEA has had an “arrest first, ask questions later” policy with regard to policing controlled substances distribution. In past years, most of the major wholesalers, FedEx, UPS, multiple pharmacies and others have been entangled in DEA enforcement actions due to their alleged inability to monitor “suspicious drug activity,” such as unusually large amounts of controlled substances being distributed to individual pharmacies. The problem, from HDMA members’ perspective, is that “suspicious” orders might be entirely legitimate. But DEA had the authority to shut down a distributor or forbid a pharmacy to dispense controlled substances, which then could leave legitimate patients out in the cold.

The law is likely not to cost a lot of government funds and could help DEA guide its own activities in more fruitful directions. Meanwhile, the ongoing crisis in prescription drug abuse is only continuing, with thousands of lives lost annually. Obama and a long list of health policy organizations and others have been holding summits, issuing position papers and calling for more support of drug addiction therapy; FDA is readying new guidance on abuse-deterrence in controlled substances. For now, managers of distribution centers and pharmacy operations can rest a little easier.