[pegleg]

This BIO Brief came thru email today. I recall us fretting over Sinemet shortages not too long ago, and this would require notification of an impending shortage.

The Food and Drug Administration is poised to publish a proposed rule to require notification from drug manufacturers of discontinuances or interruptions in the manufacturing of life-supporting and certain other important drugs.

The rule, sent to the Office of Management and Budget for final review before publication, is authorized under the Food and Drug Administration Safety and Innovation Act of 2012. Early notification of issues that could lead to shortages helped FDA prevent more than 100 shortages during 2012, according to the agency.

Now, early notification will be mandated. Under the new law and forthcoming rule, manufacturers of drugs deemed as life-supporting, life-sustaining or used in the prevention or treatment of a debilitating disease or condition must report expected production issues six months prior to discontinuation or interruption, or as soon as possible if six months notification is not practical.
Souruce: http://www.healthdatamanagement.com/...e-46289-1.html

Now, the BIG question is this: Would they define Sinemet aka carbidopa/levodopa as " life-supporting or life-sustaining or used in the prevention or treatment of a debilitating disease or condition?"

I certainly would!!!
Peggy"

[Bob Dawson]

Originally Posted by pegleg

...Now, early notification will be mandated. Under the new law and forthcoming rule, manufacturers of drugs deemed as life-supporting, life-sustaining or used in the prevention or treatment of a debilitating disease or condition must report expected production issues six months prior to discontinuation or interruption...
Peggy"

Peggy,
Thank you so much for this. It is heartening to me that someone in the U.S. Government was listening, and took action, and changed the rules. I thought at the time that we were all just talking to each other, and no one outside could or would hear us.

It was a major Alice in Wonderland episode, in which Merck became Merckie, and then Merckier, then Merckiest.

It was this sinemet shortage issue that transformed me from polite country boy to raving rebel in the hills. Pharma, you have no one except yourselves to blame for our mistrust of you.

For an in-depth look at the level of madness that prevailed, this is educational:

http://neurotalk.psychcentral.com/sh...3354&highlight

and then the conversation continued with the Britons:

http://neurotalk.psychcentral.com/thread129198.html

Dr. Michael Rosenblatt, are you now free to explain what it was all about? It had something to do with a non-compete clause in a business contract that was triggered when one company took over production of sinemet from another, and it was deemed profitable to chuck the PwP overboard. The interests of the patients were nowhere in sight. We were shark food.

And is it true that most of the world’s sinemet now comes from a factory in China, located on a flood plain in an earthquake zone near a nuclear power plant? Good thinking, Pharma. It helps keep us cognitively alert.

[pegleg]

Thanks for being the least Merkiest ( luv that) impatient patient . Without you this forum would be ever so dull.

I do miss the days where friendships were similar to those in our Junior High days, where you could count on each other to stick by friendships in the thick or thin (or was that sick and sin?) and we trusted each other enough to talk about issues openly. I guess we've all grown older together and mature and knowledgeable enough to know that the cure isn't coming "in the next 5 years."

All we do now is uncover another non- loyal stakeholder playing with our lives like we are so disposable. I don't have the energy to keep up this game, and we (the patients) have no chance of ever winning anyway.

Sorry, I'm rambling! But thanks for all you do Bob. I consider you a true friend. Now, gotta get registered for Montreal and the World Parkinson's Congress.

Peggy