President Obama has signed into law S. 2512, which adds Zika virus to the Food and Drug Administration priority review voucher program to encourage the development of treatments for neglected tropical diseases. In addition, the President has signed S. 483, the "Ensuring Patient Access and Effective Drug Enforcement Act of 2016. This law amends the Controlled Substances Act to define "imminent danger to public health or safety" for the purposes of an immediate suspension or revocation by the Department of Justice (DOJ) of a registration to manufacture, distribute, or dispense controlled substances. It also provides registrants with the opportunity to submit a corrective action plan prior to a determination by DOJ to deny or revoke a registration. In addition, S. 483 requires the Secretary of Health and Human Services to prepare a report on drug diversion and treatment, focusing on such issues as: obstacles to legitimate patient access to controlled substances; prevention of diversion of controlled substances; pain management and opioid prescribing clinical guidelines; state prescription drug monitoring programs; and prescription opioid reporting requirements.
This article is presented for informational purposes only and is not intended to constitute legal advice.