Law hasn’t hurt enforcement

The Ensuring Patient Access and Effective Drug Enforcement Act was a bipartisan, commonsense step forward to improve enforcement efforts and combat the opioid epidemic.

At its core, the law supported greater coordination between the Drug Enforcement Administration and drug manufacturers and distributors, pharmacies and doctors. In no way does it diminish DEA’s enforcement tools.

The legislation grew out of a concern that the DEA’s hitand-miss regulatory approach had created an environment of uncertainty and, more important, was beginning to impact patient access to necessary treatments.

Before enactment of the legislation, DEA issued immediate suspension orders based on its own definition of what constitutes a public health threat — a definition that was potentially ever changing. The result was a wide gray area subject to individual determinations that was counterproductive in regulating one of the most complex, vital industries in the country.

To address this, the law now provides a straightforward definition for “imminent danger to the public health.” While the law establishes greater clarity, DEA also remains fully empowered to take swift action when a “substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur.”

Sen. Orrin Hatch, one of the authors of the legislation, on the Senate floor this week thoroughly debunked The Washington Post/60 Minutes reporting and pointed out that the language on “imminent danger” came directly from the DEA and Department of Justice attorneys.

Further, the legislation went into effect in April 2016 — well after the opioid epidemic took hold. Based on this timeline, the law had no bearing on any enforcement slowdown that occurred in prior years, as alleged by the reporting.

The law was negotiated transparently with DOJ, DEA and Congress. Ultimately, it passed unanimously and was signed into law by President Obama with the full support of everyone around the table.