The opioid epidemic that has taken America into its grip has forced the federal government to take all possible measures to check the menace. President Barack Obama proposing allocation of approximately $1 billion to combat drug abuse and overdoses in the 2017 budget was one of the many steps taken by the federal government.
Opioid abuse has seen a drastic increase in the U.S., according to the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (MMWR) published in January 2016. A public outcry over prescription of opioids for treatment of acute and chronic pain related to advanced medical illness getting stronger and serious concerns raised by health advocacy groups over the loss of lives owing to the problem, the Food and Drug Administration (FDA) announced several measures on February 4, 2016.
FDA takes tough stance on opioid abuse
Dr. Robert Califf, M.D., vice chancellor of clinical and translational research at Duke University and FDA’s new deputy commissioner for medical products and tobacco, said in a telephonic conference recently that the new measures were an endeavor by the organization to tighten its grip on the crisis. Califf now also happens to be a potential candidate for the FDA commissioner’s post.
Though the plan aims at putting policies in place to reverse the opioid epidemic, the FDA has also announced measures that would enable effective relief treatments being made accessible to patients with pain. The FDA announced that it will
- ‘re-examine the risk-benefit paradigm for opioids’ and safeguard measures issued in the interest of public health
- ‘convene an expert advisory committee’ prior to approval of any new drug application for an opioid that may cause it to be abused
- ‘assemble and consult with the Pediatric Advisory Committee’ concerning the configuration for labeling of pediatric opioids prior to approval of any new form of labeling
- ‘develop changes to immediate-release opioid labeling, including additional warnings and safety information’ that include properties similar to the labeling of long acting opioid analgesics currently required
- ‘update Risk Evaluation and Mitigation Strategy requirements for opioids’ after taking into consideration the commendations provided by the advisory committee and analysis of requirements in existence
- ‘expand access to and encourage the development of abuse-deterrent formulations’ of addictive opioid drugs
- ‘improve access to naloxone and medication-assisted treatment options’ for those suffering from disorders stemming from opioid abuse; and
- ‘support better pain management options’ that include alternate treatment methods.
FDA gets appreciation and censure
While unveiling the new policies to curb the raging prescription and heroin drug scourge, Califf told Statnews.com, “We are determined to help defeat this epidemic through a science-based and continuously evolving approach.” The need felt by the FDA to overhaul its drug policies came in the aftermath of an intense condemnation, by the Congress, over the government’s inability to curtail drug abuse during its governing period.
Califf told Washingtonpost.com, “It’s fair to say we heard what Congress had to say. They are reflecting the concerns of the American people.” Emphasizing that the FDA intends to seek external guidance from pain management related experts and those adept at dealing with drug abuse, Califf added, “Things are getting worse, not better, with the epidemic of opioid misuse, abuse, and dependence. 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 strategies outlined by the FDA that were published as a policy paper titled “A Proactive Response to Prescription Opioid Abuse” in the New England Journal of Medicine on February 4, 2016 did not find many takers though. In his response to the policies announced and published, Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston told NYtimes.com, “What I’m seeing here is the F.D.A. attempting to say something in response to congressional concerns, perhaps in response to the holdup of approval of the new F.D.A. commissioner, without actually having any vision for change.”
Expressing his doubts on the blueprint declared by the FDA, Dr. Andrew Kolodny, chief medical officer at Phoenix House, a nonprofit that runs drug abuse treatment and prevention programs told Statnews.com, “If they really do reexamine the risk-benefit paradigm, it would be a game changer. But it’s hard to know if they’re sincere about it.”
Treating drug overdose problem
Both the government and the Congress seem to be on the same page regarding their concern for the lives of millions of Americans affected by drug overdose.
If you or your loved one is seeking advice regarding opioid abuse treatment, you may seek help of the Prescription Drug Abuse Helpline. Call at our 24/7 helpline number 866-450-1557 or chat online to learn more about certified therapeutic interventions and curative procedures.