Drug overdose deaths, driven by misuse of prescription opioids and drugs such as heroin and illegally produced fentanyl, are now the leading cause of injury death in the United States -- overtaking motor vehicle crashes.
That's why in the wake of the White House's Feb. 2 announcement(www.whitehouse.gov) that the president's fiscal year 2017 budget proposal will include nearly $1.1 billion in new funding to combat prescription opioid abuse and heroin use, the FDA has developed an action plan(www.fda.gov) of its own to help reverse the epidemic.
In a Feb. 4 news release,(www.fda.gov) Robert Califf, M.D., FDA deputy commissioner for medical products and tobacco, explained the agency's action plan, which is intended to help the FDA rethink its approach to opioid medications.
"Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence," Califf stated in the release. "It's time we all took a step back to look at what is working and what we need to change to impact this crisis."
The plan will focus on policies that can help reverse the epidemic while continuing to allow patients who are in pain to access effective care. In brief, the FDA plans to
- On Feb. 4, the FDA announced that it planned to rethink its approach to opioid medications.
- Because the evidence base to guide the use of opioid medications is sorely lacking, the FDA plans to strengthen the requirements for drug companies to generate postmarket data on the long-term impact of using these drugs.
- This effort comes as part of a broader national campaign led by HHS that focuses on informing opioid prescribing practices, increasing the use of naloxone and using medication-assisted treatment to help people beat addiction.
- re-examine the risk-benefit paradigm for opioids and ensure the agency is considering their broader effects on public health;
- convene an expert advisory committee before approving any new drug application for an opioid that doesn't have abuse-deterrent properties;
- assemble and consult with the agency's Pediatric Advisory Committee regarding a framework for pediatric opioid labeling before any new labeling is approved;
- develop changes to immediate-release opioid labeling, including additional warnings and safety information that incorporate elements similar to those currently required for extended-release/long-acting (ER/LA) opioid analgesics labels;
- update risk evaluation and mitigation strategy (REMS) requirements for opioids after considering advisory committee recommendations and a review of existing REMS requirements;
- expand access to, and encourage development of, abuse-deterrent formulations of opioid products;
- improve access to naloxone and medication-assisted treatment options for patients with opioid use disorders; and
- support better pain management options, including alternative treatments.
The FDA will look to outside experts in pain management and drug abuse for guidance in implementing the plan. For example, the agency has already asked the National Academies of Sciences, Engineering and Medicine to help develop a framework for opioid review, approval and monitoring.
And because the evidence base to guide the use of ER/LA opioid medications is sorely lacking, the FDA plans to strengthen requirements for drug companies to generate postmarket data on the long-term impact of using these drugs. The agency expects this to result in the most comprehensive body of data ever collected in the dual fields of pain medicine and treatments for opioid use disorder. FDA officials are confident these data will aid in better understanding the risks of misuse and abuse of ER/LA opioids and in identifying predictors of opioid addiction, among other related issues.
"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Califf said in the news release. "This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."
The FDA's effort comes as part of a broader national campaign(aspe.hhs.gov) led by HHS that focuses on informing opioid prescribing practices, increasing the use of naloxone (building on the agency's recent approvals of injectable and intranasal naloxone) and using medication-assisted treatment to help people beat addiction.
The FDA's action plan also follows the release of the CDC's draft 2016 Guideline for Prescribing Opioids for Chronic Pain,(www.regulations.gov) which is intended to be used by primary care professionals who treat patients with chronic pain in outpatient settings.
The AAFP recently provided mixed comments on the CDC guideline, agreeing with a number of its recommendations, but expressing concern about others. By and large, that concern stemmed from a lack of high-quality evidence to support what the agency deemed to be strong recommendations for practice.
Although an AAFP representative served as a member of the core group that developed the guideline, the Academy won't decide whether or not to endorse the document until the CDC reviews feedback on its proposal and releases its final guideline. AAFP experts will carefully assess that final version before determining whether to agree with its recommendations.
Related AAFP News Coverage
AAFP Joins White House Conversation on Opioid Abuse