FDA Plans to Increase Oversight of Opioid Prescriptions

Dr. Lynne White-Shim, Assistant Director, Scientific Activities Division

On February 9, the Food and Drug Administration (FDA) announced its plans to exercise broad new authorities under Food and Drug Administration Amendments Act (FDAAA) to require Risk Evaluation and Mitigation Strategies (REMS) for many of the opioid drug products.

A "REMS" is required if the FDA finds it is necessary to ensure that the benefits of a drug or biological product outweigh the risks of the product. The FDA is concerned that certain opioid drugs are negatively impacting human health through improper use, accidental overdose and diversion.

The FDA has the ability to implement a REMS using various vehicles. However, the FDA is most closely considering "elements to assure safe use," which can include:

• special certification or training requirements for opioid prescribers or pharmacies
• availability of opioids only in certain health care settings
• drug dispensing to patient with documentation of safe use conditions such as laboratory results
• requiring that each patient be either subject to certain monitoring or enrolled in a registry

The AVMA acknowledges the FDA's efforts to ensure that the benefits of medications to human health outweigh risks of adverse effects, and we understand the FDA's concern about safety of opioids in people.

However, the AVMA is not aware of adverse health impacts of opioids in our animal patients, yet limiting opioid drug availabilities for human patients could adversely impact veterinary patients. Veterinarians need access to opioids to alleviate animal pain and suffering, and most of the opioid drugs used in veterinary medicine are human-approved drugs. Veterinarians have the ability to administer these drugs under the Animal Medicinal Drug Use Clarification Act (AMDUCA), a codified and tightly regulated activity under the FDA's oversight.

The AVMA cautions against unintended consequences that could result from implementation of a REMS that would limit the availability of opioid drugs to prescribers, including veterinarians. The AVMA is seeking an exemption from the REMS process, to ensure that our ability to treat our animal patients is not hindered.

The FDA will consider comments through June 30.

Do you have expertise to offer for AVMA consideration? Send your feedback to the Scientific Activities Division at scientificissues@avma.org.