Regulatory Brief

 Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs


Formal title: Docket Number [FDA-2009-N-0143] Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting

The Food and Drug Administration (FDA) announced a Notice of a Public Meeting on the Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs.

Brief Description:

The FDA has announced a public meeting to obtain input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. The REMS would be intended to ensure that the benefits of these drugs continue to outweigh certain risks. The FDA intends to use its REMS authority under the Food and Drug Administration amendments Act of 2007 (FDAAA) to mitigate the risks of these drugs.

AVMA Response:

The AVMA acknowledges the efforts by the FDA to examine the benefits and risks of certain opioid medications for use in human medicine. The AVMA understands the FDA's concern and its need to assure safety of opioids use in people. However, the AVMA strongly recommends that all DEA-registered, licensed veterinarians continue to be able to prescribe opioids, even under new requirements for additional certification. The AVMA also asserts that DEA registration and tight federal and state oversight over use of controlled substances has been effective in controlling diversion as diversion concerns are minimal in veterinary medicine.

The AVMA believes the risks posed by veterinary use of opioids are small. Consequently, the AVMA urges continued veterinary medical access to needed opioids and an exemption from the REMS process that is being crafted for human health care providers.

Background Documents:

View Federal Register document (PDF)

Status:

The AVMA responded on June 30, 2009. (PDF)

The AVMA responded on September 1, 2009. (PDF)