Regulatory Focus™ > News Articles > FDA Looks to Reassess Hydrocodone Products

FDA Looks to Reassess Hydrocodone Products

Posted 08 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is planning to revisit a benefit:risk assessment for a powerful painkiller subject to escalating amounts of addiction and abuse after the agency was pressed by a national drug control agency.

In an 8 June Federal Register posting, FDA said it had been petitioned by the US Drug Enforcement Agency (DEA) to look at how the government classifies hydrocodone, which is subject to restrictions under the Controlled Substances Act (CSA).

The product class is often subject to "misuse, abuse and addiction" as a result of its properties, explained FDA in the Register posting. As a result of the substance control issues, the US Drug Enforcement Agency (DEA) requested FDA conduct a new scientific and medical evaluation to support a scheduling recommendation for the product class.

Substances can be classified by a number of control "schedules" under the CSA. Schedule V controlled substances are subject to the least restrictions, while Schedule I controlled substances are subject to the most restrictions. Most forms of hydrocodone are currently classified under Schedule III restrictions, meaning they are moderately restricted in light of their perceived potential for abuse.

DEA is purportedly asking FDA to support findings that the drug should be classified under Schedule II restrictions, which indicates the drug has a high potential for abuse. Schedule II is the most restrictive category for drugs with medicinal purposes.

The meeting of the Drug Safety and Risk Management Advisory Committee comes in the midst of a legislative battle over the same issue. While the Senate is in favor of more restrictive provisions, it is getting furious pushback from some outside groups, reports The Pink Sheet Daily. The Schedule change would subject hydrocodone to additional restrictions, including smaller prescribing amounts requiring more frequent physician interaction. Pharmacist groups are maintaining states should be able to set their own restrictions to account for the needs of their respective populations. Still others are asking for the DEA and FDA to review the drug, which would conceivably make it easier to adapt in the future relative to a congressional scheduling mandate.


Read more:

Federal Register - Drug Safety and Risk Management Advisory Committee

Bloomberg - Vicodin-Type Pain Pills May Face Stricter U.S. Regulation

The Pink Sheet - Hydrocodone Gets Advisory Committee Review, Offering Congress A Scheduling Out


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