The Abuse ‐​Deterrent Folly

Jeffrey A. SingerOn September 11 a  Food and Drug Administration Advisory Committeerecommended rejecting Purdue Pharma ’s request to add to the label of the abuse‐​deterrent formulation (ADF) of its drug OxyContin the claim that it reduces the incidence of non‐​medical use and overdose from opioids.In the early part of this century law enforcement officialsreported that many non ‐​medical users of the diverted prescription drug OxyContin, a concentrated, slow‐​release formulation of oxycodone, would crush the pills and snort them, or dissolve them in liquid and inject them. In 2010, as its patent for OxyContin was about to expire and cheaper generic competitors wer e waiting in the wings, Purdue Pharma received FDA approval to release its reformulated ADF OxyContin. This reformulation made the pills uncrushable and insoluble in liquid. The reformulation approval meant Purdue Pharma could extend its patent—and its monopoly—over the production and sale of O xyContin. Extending drug patents by reformulating drugs in a meaningful way—a process known as “evergreening”—is a common practice in the pharmaceutical industry.In anironic twist, the pharmaceutical company that was, by then,  the opiophobia‐​drivenscapegoat for the overdose crisis sought to profit from  further stoking opiophobia. The FDA didn’t just approve the ADF of OxyContin–itencouraged drug makers to develop ADFs of all opioid pain relievers, with the ultimate goal ...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs