FDA Unveils Sweeping Changes to Opioid Policies
In response to the ongoing opioid abuse epidemic, top officials at the US Food and Drug Administration (FDA) today announced plans to reassess the agency’s approach to opioid medications.
“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” Robert Califf, MD, the FDA’s Deputy Commissioner for Medical Products and Tobacco, said in a 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 statement says the multicomponent plan will focus on policies aimed at reversing the epidemic, while still providing pain patients access to effective medication. Specifically, the FDA plans to:
* Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public-health effects;
* Convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties;
* Assemble and consult with the 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 of the extended-release/long-acting (ER/LA) opioid analgesics labeling that is currently required;
* Update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;
* Expand access to, and encourage the 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 says they will seek guidance from outside experts in the fields of pain management and drug abuse. The agency has already asked the National Academy of Medicine to assist in developing a framework for opioid review, approval, and monitoring that balances an individual’s need for pain control with considerations of the broader public-health consequences of opioid misuse and abuse.
The FDA says it will convene independent advisory committees made up of physicians and other experts when considering approval of any new opioid drug that does not contain abuse-deterrent properties. The agency will also convene a meeting of its standing Pediatric Advisory Committee to provide advice on a framework for pediatric opioid labeling and use of opioid pain medications in children.
The FDA also plans to tighten requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids, an action, they say, that will generate the “most comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data will further the understanding of the known serious risks of opioid misuse, abuse, overdose and death.”
Drug overdose deaths, driven largely by overdose from prescription opioids and illicit drugs like heroin and illegally-made fentanyl, are now the leading cause of injury death in the United States.
“Things are getting worse, not better, with the epidemic of opioid misuse, abuse and dependence,” Dr Califf said. “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.”
“Agencies from across the Department of Health and Human Services and throughout the federal government are united in aggressively addressing this public health crisis,” US Health and Human Services (HHS) Secretary Sylvia M. Burwell, said in the news release. “The FDA is a vital component to combating this epidemic, and the innovation and modernization they have committed to undertaking is an important part of the overall efforts at HHS.”
Last spring, HHS announced a major initiative to address the opioid abuse epidemic in the US. The initiative focuses on informing opioid prescribing practices, increasing the use of naloxone, and using medication-assisted treatment to move people out of opioid addiction.
The FDA says it will provide updates on progress with the goal of sharing timely, transparent information on a regular basis.
Filed under: General Problems
Join us on our new page Unifying Chronic Pain Warriors. Lots of info. We need people to speak up . support each other and work together to make sure we are not another statistic. ..
https://www.facebook.com/CriminallyInpain/
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It’s time the chronic pain community starts taking control of the dialog. The present controllers are directing the discussion in a way that totally marginalizes and minimizes the legitimate users of opioid medications. Am I the only one that see’s the hypocrisy here. It is recognized by the folks in the know that addiction is a disease. Yet, addiction and anything that even looks like it is still treated as a crime. The various and sundry minions of the State pay lip service to the “addiction is a disease” idea while still treating it like a crime. The primary actors in treating any disease are the health care system and, of course, the patients. With addiction we still see the law enforcement types as the primary actors and the public service minions, e.g., elected officials and the appointed bureaucrats as their “cheerleaders and boosters”, leading the way to create more laws and enforcement around the addiction issue. Here is the mound of stinking hypocrisy…Do we see the hysteria surrounding high carb and surgery foods? No. yet these substances exacerbate diabetes and other metabolic disorders to the point of death more than the supply of opioids, both legal and illicit” do with the addiction community. So why don’t we have a CEA (Carbohydrate Enforcement Agency)? How about the high amounts of saturated fats and cholesterol related to the atherosclerosis family of diseases? Do we have an LEA (Lipid Enforcement Agency)? No, of course not. Yet between the various and sundry metabolic and atherosclerotic diseases in this country, we have rates of morbidity and mortality at least a couple of orders of magnitude greater than the opioids are allegedly causing in the addicted population. No one is seriously taking the call to put every American on a low-carb, vegan diet as a public safety measure or a public health measure or whatever prevaricative excuse that can be created for the State, to control the day to day life of the average citizen.
Why has the media not picked up on the FACT that since the “big crackdown” that started about 5yr ago; has caused the # of prescriptions written for opioids & the abuse of RX opioids have gone WAY down even as much as 80% in some areas?
So why has the rate of opioid related deaths & suicides gone way up?
Anyone can clearly see that something is just not adding up or is it?
Yes they have stopped the pill mills & dr dealers, which they should have never let happen in the 1st place; let alone allow them to go on for at least 10 yrs.!! Funny the crackdown came once we got control of the poppy fields in Afghanistan!
Could it be that the reason that opioid related deaths are going up not due to RX opioids, but instead are illegal opioids like heroin & fake fentanyl that are being used by not only addicts wanting a high; but legit CPP’s that were compliant & stable long term until they were forced off their badly needed meds. due to fear?
Now those like dr kolodny & prop are twisting the REAL FACTS & using these wrongful deaths that they caused w/ all their anti opioid propaganda BS, to justify & push even more life threatening restrictions in the guise of addiction prevention!!
You are exactly correct, the facts are not adding up and won’t UNTILL they stop using inaccurate statistics and data on many, many, topics rolled into one. Heroine abuse and legitimate treatment of Chronic pain shouldn’t be in the same zip code. Imagine if you could how up in arms people would be if they demonized alcohol and called it an epidemic, If the lawmakers couldn’t go home at the end of the day to a scotch and water, what would they do ? 1+1 will never equal 2 UNTILL they use reliable facts, the right statistics, and separate the issues appropriately. Chronic pain and its treatment is one issue to itself. No heroine, no diversion, no mixing in unrelated deaths, it costs a fortune for them to get it wrong. And who really pays the price ?
STOP LUMPING RX PAIN MEDICATIONS WITH HEROIN AND BLACK MARKET FENTANYL!!!!
WTF????? IT’S LIKE COMPARING APPLES TO ORANGES.
Amen!!! I’m not a heroine addict I’ve only had the same opiate Rx’s for chronic pain for the past 17 years same dosages since my youngest daughter was born born on and I had to go back on my meds so I could properly take care of her.
When r the true facts going to be presented and used by our government ? 1) Accurate and separated statistics regarding heroin versus prescription opiates overdoses. 2) Definition of chronic vs acute vs cancer pain. 3) Strong scientific consideration of the health effects of under treated pain. ???
Great questions. I doubt we’ll ever get the answers to those questions.
Wow. Instead of the FDA standing up to the CDC, they capitulated. I don’t know what kind of power PFROP has, but it’s obviously very influential. And freaking scary.
Scary indeed! You ask about how they can be so influential? Money equals power. I think it only boils down to the simple equation.
Time to start bombarding FDA with facts, letters and testimonials.
Sounds like this is gonna be another LONG TERM costly plan to spend taxpayer dollars to find out what is already common knowledge, then once the data is official they will come up with a hurtful plan to the people who need it the most. Typical