The U.S. Food and Drug Administration (FDA) aims to ensure that patients living with serious chronic pain, such as patients with cancer, or end-of-life pain, have access to the safe and effective treatments they need. For some individuals, this treatment includes the careful use of opioid medications.
We also know, however, that inappropriate prescribing and the misuse of these powerful drugs can lead to dependence, unintentional overdose, and death, and the FDA has a responsibility to aggressively confront the opioid crisis gripping our country. In response, the FDA is working on many fronts.
As we put in place policies to reduce the rate of opioid use disorder and confront new risks, we’re also working to change the culture around how we treat and manage pain by strengthening access to skillful, appropriate, science-based medical care for patients while reducing the risks posed by inappropriate use of certain medications.
Prevention strategies
On the prevention front, the FDA is advancing policies that reduce the overall number of opioids prescribed and used. This ensures that the drugs are prescribed in alignment with their approved, indicated use.
The FDA is also strengthening labeling to address safety issues for products on the market, supporting the development and expanded use of medication-assisted treatments for opioid use disorder, examining ways to increase access to naloxone for overdose reversal, and increasing enforcement and interdiction at the border and international mail facilities to prevent illicit drugs from entering our country.
Exploring alternatives
The FDA is also working to encourage the development of safe and effective non-addictive alternatives to treat acute and chronic pain without the same risks of dependence and addiction as opioid medications. The FDA recently approved the first generic versions of Lyrica (pregabalin) to treat pain from diabetic neuropathy and other neuropathic pain.
We’re encouraging the development of opioid products to include features that prevent individuals from using them via non-approved routes and promoting the development of more affordable, generic versions of overdose reversal products, including the approval of the first generic naloxone nasal spray, a complex generic granted priority review, to increase access to this life saving medication.
The FDA is also helping spur the development of medical devices, digital health technologies, and diagnostic tests that can offer new solutions to detecting, treating, and preventing opioid use disorder, addressing diversion, and treating pain.
The opioid crisis is an issue of great concern for our nation. Addressing it is a public health priority for the FDA. We are committed to confronting this crisis while also paying careful attention to the important needs of patients and the physicians and clinicians managing pain.