Senator Markey places hold on Obama's nominee to lead FDA

[Eugene]

Source: Reuters

Democratic U.S. Senator Edward Markey of Massachusetts said on Monday he has placed a hold on President Barack Obama's nominee to head the Food and Drug Administration until the agency agrees to reform its process for approving opioid painkillers.

Markey wants future opioid-approval matters to be reviewed by an FDA advisory committee, and believes the committee should consider the risk of addiction and abuse during the approval process. He also wants the agency to rescind approval of OxyContin for children and convene an advisory panel to guide that process.

"Last year, the FDA approved a new pediatric use for OxyContin without convening an advisory committee even though its guidelines note that FDA decisions that relate to controversial issues or matters relating to children are particularly well-suited to advisory committee empanelment," Markey said in a statement.

The nominee, Dr. Robert Califf, a cardiologist and researcher, is widely expected to be approved when the Senate votes on the nomination later this year, though critics argue his ties to the pharmaceutical industry are too close.

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Read more: http://www.reuters.com/article/us-fda-califf-markey-idUSKCN0V32CR

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Politics | Mon Jan 25, 2016 2:40pm EST

[KoKo]

1. K&R!

[NotHardly]

2. Don't trust the lot of them...

FDA in pocket of pharmabros, Senate in pocket of hedge-funds and billionaires, and as such, what we get is political pander as medical advise and rules without thought to needs of the public (let alone any rights) and needs of individual medical clients. Blanket orders and interference of the likes of folks like Markey is more about wanting and allowing people to suffer (pain is good and payment of sins) for these "believers" in the human condition. Its not about reform except to remove medical opportunities for those in need. Little folks don't matter much anymore, maybe they never did.

[billhicks76]

4. That Means Dont Trust Obama

Last edited Mon Jan 25, 2016, 06:56 PM - Edit history (1)

Harmless, healing Cannabis is federally banned but tens of thousands of OxyContin overdoses for kids is fine as long as BigPharma gets rich? Something not right here. Obamas words are hollow and just that...words.

[Punx]

5. See my post below

Couldn't agree more.

[billhicks76]

6. Yes Anyone Can Say Anything

We need to only look at actions. Forget words.

[Punx]

3. I'd say

Leave the hold on until the FDA removes Cannabis from Schedule I. The DEA would also have to sign on as well, but worth a try.

[LTG]

8. Neither the FDA or the DEA have any direct involvement in the scheduling of drugs

The original placement of drugs on various Schedules was done by Congress within the Controlled Substances Act. Congress periodically reviews the Schedules and may add or remove drugs.

In that same Act, the Congress granted to the Attorney General the power and duty of placing or removing a drug on/from one of the Schedules. The AG may also move a drug from one Schedule to another

The Act requires that the AG gather specified information regarding the drug. The AG then sends the data to Secretary of HHS for evaluation. The Secretary makes recommendations to the AG regarding Scheduling or removal of the drug.

Based the information gathered by the AG, and consideration of the guidance of the HHS Secretary, the Attorney General makes a determination as to whether a drug is placed on a particular Schedule, moved between Schedules or removed from the Schedules altogether.

At least that's how I remember it from my studies and which may or may not be current. I welcome corrections of the above from anyone with more current and accurate information.

[fredamae]

7. A Minority of people Abuse

these drugs for personal use. They need Health Care not Courts!
What the Hell about the people who use them responsibly and absolutely Suffer horrifically from these rules? I am sick and tired of lawmakers USING the Minority of Cheaters as an EXCUSE to Punish the Whole!

[RussBLib]

9. like myself

I have had chronic foot pain for almost 10 years. I have tried a multitude of treatments: acupuncture, electro-stimulation, massage, yoga, orthotics, physical therapy, vitamins....but nothing has given me relief like Hydrocodone. It's the only thing that has enabled me to walk like a "regular" person. In the last few years, it has been getting harder to get the drugs. The hoops they make you jump through are getting very small and high up there. And all because some people are abusing the drugs and selling them on the black market. I live in fear of the day they pull the opiods away from me and I will have to just deal with the pain. Some of the pain was so bad over the last few years I was contemplating suicide. Maybe that's what they want. Those of us who are suffering, just die already and get out of the way.