FDA Advisors Reject Agency Plan to Control Opioid Use as Too Soft

[Sp33dy]

http://abcnews.go.com/Health/PainMa...cy-plan-control-opioid-soft/story?id=11240232

DELPHI, Md. -- A U.S. Food and Drug Administration advisory committee voted 25 to 10 to reject the agency's proposed plan to prevent inappropriate prescribing, misuse, and abuse of extended-release opioid painkillers, saying the plan lacks the teeth to stem the "public health crisis" of opioid addiction, overdose, and death.

The agency's plan to put a risk evaluation and mitigation strategy (REMS) in place would have required drug companies that make extended-release opioids to develop educational programs to guide physicians in patient selection, dosing, and patient monitoring. Prescribers were also to have been trained to counsel their patients on how to safely store and dispose of opioids.

The REMS would also have required manufacturers to provide FDA-approved patient education sheets for physicians to use in their interactions with patients and create "medication guides" highlighting safe use of opioids to be dispensed with the drugs.

 

[Khadijah]

jesus fuckin christ they aint gonna be happy until the only people who get pain medications are the ones on their goddamn death beds. I would say "and the people who got limbs hanging off", but i dont think that would get you meds. becuz yea, you MIGHT have a arm or leg blown off or tore off, you might be broke in half from a severed spine, but you might LIKE IT if they give you pain meds. Wat if you a junkie who happened to get horribly injured? then you WANT pain meds, and you might ENJOY them. so just to be safe, dont give any to those people neither. becuz, you know, since 10% of the people who come in to the ER's and dr's offices might be fakin it , the goal of making sure that NO JUNKIE *EVER* gets high off a dr's supply is far more important than givin the necessary pain relief to people who are legitimately in pain and truly need it. as long as we keep one junkie from gettin high, the 9 people who were in horrible suffering can suck a dick.

this shit is so horrible, they will never ever ever control the rates of opioid addictions by restricting who get the pills. theyll just create more heroin addicts. stupid, stupid sons of bitches.

 

[phr]

Well, they rejected a plan that seemed to basically better inform patients and doctors about the risks. That could have decreased opiate prescriptions and use.

Not sure why they'd do that, but I bet lobbying was involved.

 

[FacedAgain]

I cam imagine is was something of a legal objection. I think having approved guidelines and usage would open them up to litigation..

 

[theotherside]

I thought they were going to get rid of APAP containing meds....what happened to that?

 

[panic_the_digital]

I can't believe the APhA didn't lobby to have pharmacists perform the drug consults. That would be some mad money for reimbursement.

 

[Roger&Me]

I cam imagine is was something of a legal objection. I think having approved guidelines and usage would open them up to litigation..

Whatever, America is the most litigious society on planet Earth and that is the main problem here.

If these dickhead legislators had balls, they would do the right thing regardless!

 

[Moredopamine]

In my own little world, I'd be able to buy opioids OTC. I have a fundamental right to stimulate my own mu opioid receptors, thanks.

 

[cryan]

jesus fuckin christ they aint gonna be happy until the only people who get pain medications are the ones on their goddamn death beds. I would say "and the people who got limbs hanging off", but i dont think that would get you meds. becuz yea, you MIGHT have a arm or leg blown off or tore off, you might be broke in half from a severed spine, but you might LIKE IT if they give you pain meds. Wat if you a junkie who happened to get horribly injured? then you WANT pain meds, and you might ENJOY them. so just to be safe, dont give any to those people neither. becuz, you know, since 10% of the people who come in to the ER's and dr's offices might be fakin it , the goal of making sure that NO JUNKIE *EVER* gets high off a dr's supply is far more important than givin the necessary pain relief to people who are legitimately in pain and truly need it. as long as we keep one junkie from gettin high, the 9 people who were in horrible suffering can suck a dick.

this shit is so horrible, they will never ever ever control the rates of opioid addictions by restricting who get the pills. theyll just create more heroin addicts. stupid, stupid sons of bitches.

I was a heroin-addict on suboxone maintenance for about 2 years, and recently needed an emergency surgery.. because of the fact that I was a junkie two years ago, I walked out of the hosp with a rx for 30 5 mg Percs, no refills and doc denied my refill request. This stigma is gonna follow me around forever, so much to the point where I almost wish I'd never even done the suboxone maintenance and just tried to get clean without help (although I know that never would have worked). And the worst part is, because I was in so much pain I had to call the doc office a bunch of diff times tryna get a refill, and we all know how bad that makes you look. Hah.