Legislation aims to change opioid labeling

Legislation aims to change opioid labeling


Two U.S. Senators introduced a piece of legislation Thursday which would prohibit the Food and Drug Administration (FDA) from allowing opioids to be labeled for intended use of “around-the clock, long-term opioid treatment.”

The FDA Opioid Labeling Accuracy Act, introduced by U.S. Sens. Joe Manchin, D-W.Va., and Mike Braun, R-Ind., would prohibit such labeling until a study can be completed on the long-term usage of opioids.

“In the United States, we consume 80 percent of the world’s opioid production and in 2017, one single year, over 70,000 people died due to drug overdoses,” Manchin said in the release. “These statistics are unacceptable. As one of the hardest hit states, West Virginia has been on the front lines of the opioid epidemic, which is why I have introduced this bill today with Senator Braun to address how the FDA approves opioid prescriptions for treating different types of pain.”

In 2001, the release said the FDA updated opioid labels to indicate use from “moderate to severe pain where use of an opioid painkiller is used for more than a few days” to “management of moderate to severe pain when opioids are needed for an extended period of time.”

With this change, opioids began to be prescribed as a first line of treatment for long-term chronic pain that surpassed the original intended use for cancer pain or short term post-surgical pain and definitively contributing to the heightening of the opioid epidemic.

The FDA Opioid Labeling Accuracy Act would prohibit opioids from being labeled for intended use to treat long-term chronic pain, except for cancer pain, end-of-life care or when a prescriber has determined that all non-opioid treatments are inadequate or inappropriate.  

— Email: wholdren@register-herald.com and follow on Twitter @WendyHoldren

This past Monday, Senator Braun had a “town hall meeting” in Corydon IN.  At one point he was talking about “Medicare for all”.. which apparently he was not in favor of.  I tried to point out to him that what “they” are talking about is “MEDICAID FOR ALL” because it would seem that they are talking about paying for FIRST DOLLAR for everyone’s medical care..  I pointed out that Medicare required premiums, deductibles, co-pays and it was MEDICAID that may have minimal copays … mostly on prescriptions… otherwise the pt has “no skin in the game” …   He went right back to talking about “MEDICARE FOR ALL”

Senator Manchin, in the last Congressional session, proposed a “opiate prescription tax” to get money from group of pts (chronic painers ) to pay for the treatment for another group of pts (substance abusers).

4 Responses

  1. these stupid senators do not have a medical degree therefore they are breakingg the law and need to be aresstsed imediately and throw away the kep, They have NO idea what they are talking about and should be thrown out of office and never can run again,

  2. Senators Braun (R) Indiana and Manchin (D) West Virginia are now attempting to force the FDA to abandon…..pain management patients with “legislation”. Patients that have done well with prescribed opioid medication for years, decades. They are citing that opioid medication is not beneficial for “chronic” pain management. WHAT will develop that is beneficial, monetarily, to them with this legislation? The Senators are apparently NOT concerned about the millions of pain management patients that are “still alive” with a documented history of pain management. Those who have used prescribed opioid medications without ANY negative results. NO compromise. Realization of published fact and patient documentation by our physicians that for many, opioid medication IS the only therapy we have for now.What about future pain generating injury, disease? It is a truly a war against opioid medication regardless of the beneficial use. A war weaponizing our physicians against the millions of legitimate “chronic” pain patients. Physicians that have used their qualifications, due diligence, and documentation of beneficial use of opioid medication to help ease the suffering of those that did not ask for lifetime pain! Can they not realize that “they”, one of their family members or a loved one is a tick of the clock away from needing pain management with opioid medication when all else fails OR do they fully realize that as our “leaders”, our legislators, the same “rules” , law,does NOT apply to them nor they loved ones?

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