Congress Seeks Tougher FDA Approval Process for Opioids

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the FDA.

New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the FDA.

The bill, the FDA Accountability for Public Safety Act, is a response to FDA's regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013 as a pure hydrocodone product lacking any physical characteristics which could make it more difficult to misuse or abuse. Zohydro's approval was considered somewhat unusual in that FDA bucked the advice of its advisory panel, which cited the drug's potential for abuse when recommending against its approval.

Zohydro's approval was an immediate source of controversy for FDA and the drug's manufacturer, Zogenix.

Read more at Regulatory Affairs Professional Society: http://bit.ly/1zDpseh