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Ensuring Patient Access and Effective Drug Enforcement Act of 2016


On April 19, 2016 President Obama signed into law the Ensuring Patient Access and Effective Drug Enforcement Act of 2016.

The Act requires the DEA to show a substantial likelihood of harm related to a Registrant's actions before issuing an Immediate Suspension Order pursuant to 21 U.S.C. 824(d). In the past, the Administrator had the authority to issue an immediate suspension order where he/she made a finding of "imminent danger to the public". This phrase was not previously defined and was applied broadly, without consideration of a Registrant's remedial actions. The Act defines "immediate danger to public health" sufficient to issue an immediate suspension. The new definition places a burden on the DEA to demonstrate a direct causal relationship between a Registrant's actions or inactions and specific adverse results.

Additionally, the Act requires the DEA to give a Registrant the opportunity to submit a corrective action plan in response to a specific Order to Show Cause (OTSC). If the corrective action plan is sufficient to address the allegations of the OTSC, the OTSC may be deferred. Unfortunately, the Act does not identify how the DEA must evaluate a proposed corrective action plan.


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