Hydrocodone

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Nobody would argue with the fact that there is an opioid crisis in our country – it is a demonstrable fact. However, there has recently been a significant focus on whether drug wholesalers and their business partners including lobbyists have caused people to die from overdoses, including a recent segment by 60 Minutes. While the segment sought to educate viewers on the causes of prescription drug abuse and the alleged slowdown in enforcement efforts by the government, it is of course journalism and takes a strong position against drug companies. Aided by reporters from the Washington Post and former employees from the Drug Enforcement Administration (“DEA”), the 60 Minutes segment, while dramatic in its presentation, only told the facts relevant to the position it was taking – which is what makes good headlines.
Continue Reading The Other Side of the Story: DEA Enforcement in the Opioid Crisis

In 45 days, hydrocodone combination products (“HCPs”) will be Schedule II controlled substances.  This means that by early October, manufacturers, wholesalers, pharmacies, prescribers, and everyone in the drugs’ supply chains will have to be in compliance with the more restrictive regulatory requirements applicable to Schedule II drugs.

In a previous post we discussed whether the…

On Thursday, February 27, 2014, the DEA issued a long-awaited Notice of Proposed Rulemaking (NPRM) seeking to reschedule hydrocodone combination products as Schedule II controlled substances.  In a previous post we questioned whether such a step would actually have an impact on the abuse and diversion of these drugs.  DEA relied on the scientific analysis…

FDA recently announced that it was recommending that hydrocodone combination products be moved from Schedule III to Schedule II under the Controlled Substances Act.  The placement of hydrocodone combination products in Schedule II is a great idea — for 2003.  But FDA’s belated action is unlikely to have a significant impact on prescription drug abuse.  …

DEA’s position on oxycodone is clear — more or less. In DEA’s letter to FDA supporting a petition to restrict the approved labeled use of oxycodone to “severe pain,” DEA said that “abuse of prescription opioids have increased markedly over the past decade.”  In the letter DEA also expressed support for the legitimate and beneficial…