On March 4, 2015, the Government Accountability Office (GAO) released a report titled, Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved. GAO’s report examined, (1) the trends in such shortages, (2) the effect on patients and providers, (3) DEA’s administration of the quota
Second Bill Introduced in the Senate to Amend the Controlled Substances Act
As we previously reported, on February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. Also on that date, the Senators introduced legislation that would also amend the Controlled Substances Act, as well as the Food, Drug, and Cosmetic Act. This legislation addresses, among other things,
DEA Takes the First Step Towards Rescheduling Hydrocodone Combination Products
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
Hydrocodone Rescheduling: Yesterday’s Solutions for Today’s Problem
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.
Changes Ahead: New Rules for Painkillers
FDA Announces New Labeling and Postmarket Studies Requirements for Painkillers
On September 10, 2013, the FDA announced its plan to issue new regulations for labeling extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain. According to the FDA, the labeling changes “will include important new language to help health care professionals tailor their prescribing
Eisai Inc. Sues DEA
On Monday, Japanese drug maker Eisai Inc. filed a lawsuit against the DEA in the District of Columbia Court of Appeals. Their complaint? Eisai created a drug, called Fycompa, that the FDA approved last October to treat epileptic seizures. Due to FDA’s scheduling recommendation and the drug’s effect on the central nervous system, the DEA
DEA’s Uneasy Relationship with Oxycodone
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