FDA Issues Statement On Prescription Opioid Abuse

In a statement made April 3rd, the U.S. Food and Drug Administration (FDA) commissioner, Margaret A. Hamburg, discussed her agency’s efforts to address the public health crisis resulting from improper use, abuse, addiction, and overdose of prescription opioid products. The FDA hopes to address these problems, while still protecting the availability of these effective medications for patients who suffer from pain.

According to the statement, 16,000 deaths occur annually from opioid-related overdoses. Misuse of these medications is often directly related to inappropriate prescriptions, poor disposal of unused medications, and illegal activity perpetrated by some of healthcare providers. Commissioner Hamburg noted, “This highlights the important role that education of prescribers and patients can play in addressing this epidemic. The FDA has taken steps to address this but more work remains to be done.”

For over ten years, the FDA has taken measures to curb opioid misuse and to boost the development of new pharmaceutical therapies to fight pain. The steps taken to-date include:

• Changing opioid product labeling to encourage their safe and appropriate use. The most recent change was to the indications and safety warnings on extended-release and long-acting opioid products.

• Requiring that opioid manufacturers test the long-term safety of extended product use.

• Encouraging appropriate physician prescription and patient use by requiring educational materials for extended-release and long-acting opioids.

• Expediting the review of non-opioid pain medications entering the market.

• Partnering with other government agencies and scientists to further scientific understanding of pain pathways and mechanisms, and methods for treating pain, especially non-opioid options.

• Moving hydrocodone-containing products from Schedule III to Schedule II to add restrictions to their use.

• Bolstering surveillance programs to identify new issues in opioid prescription abuse.

• And, finally, fostering the development of therapies for opioid abuse like buprenorphine and naloxone.

The FDA noted that it must have partners in this battle and is working with the White House Office of National Drug Control Policy, the Drug Enforcement Administration, agencies within the Department of Health and Human Services, state and local governments, public health professionals, health care providers, addiction experts, researchers, industry, and patient groups.