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HAS A CERTAIN DRUG COMPANY INFLUENCED THE FDA TO STALL THE RELEASE OF NEUPRO?

Posted Apr 23 2010 8:48pm

Today I am writing in red….that’s because I am in a rage about the Press Release from UCB Schwarz Pharma regarding the Neupro patch.  Today I learned that the United States Food and Drug Administration has given UCB a Complete Response Letter telling them that they need to re-formulate the Neupro patch before it can be released.

Yes, I’m livid….just as other Americans with Restless Leg Syndrome and Parkinson’s Disease will be when they realize that the FDA, (which exists because of our tax money) has stalled UCB and asked that they reformulate the Neupro patch.

I’ve been in this Phase 4 FDA trial for the Neupro patch.  There are no crystals on the patches when they are refrigerated.  The new glue sticks better than the old glue (even in the 100 degree/98% humidity weather in Central Texas).  However, NOW the FDA has determined that even though cold storage has decreased the crystals on the patches….they must be reformulated.  People, this can take up to two years for this to happen!!

You do realize that the Neupro patch is available through Canadian and European pharmacies and those tens of thousands of people are using the same patches without incident?  You do realize that last week at the 62nd American Academy of Neurology annual meeting in Toronto, Canada evidence was presented that showed improvement in motor and non-motor symptoms of Parkinson’s Disease when patients used the Neupro patch?

So, this makes me wonder if a certain “competitor drug manufacturer” in the U.S. has influenced the FDA to stall the release of the Neupro patch?  In fact, recently, that  “competitor drug manufacturer” released the Requip XL, which is the once a day tablet formulation of the same drug in the Neupro patch.  BUT OF COURSE, I CAN’T TAKE REQUIP BECAUSE I VOMIT CONTINUALLY ALL DAY BECAUSE OF THE SIDE EFFECTS.

We aren’t stupid!  Every informed consumer of drugs knows that “competitor drug manufacturer” was elated when Requip XL was approved by the FDA because their revenues were sliding downward. Those revenues were decreasing because their patents expired on antidepressant Wellbutrin, Zofran for nausea and Coreg for high blood pressure.  And additionally, “competitor drug manufacturer” faced the slow down in sales of Avandia, a popular drug for diabetes.  If the Neupro patch is released to the U.S. population, would that cause a downward slide in the current sales of Requip XL?

So, I wonder, as do others….did “competitor drug manufacturer” whine, plead and influence the FDA to stall the release of an alternative to Requip XL?  I’ll let you draw your own conclusions.  I am naturally suspicious and (as my readers know) I can be somewhat negative.  So, I feel there is some under-handed influence in this situation, I don’t have proof, just a sneaky suspicion in my gut.

But I will tell you this, for the tens of thousands of Europeans and Canadians who SAFELY use the current Neupro patches without incident, there are just as many Americans with Parkinson’s Disease and Restless Leg Syndrome who will now have to scramble to be able to afford these drugs from foreign pharmacies.  Our insurance companies will NOT cover these foreign prescriptions and we will be forced to purchase them out of pocket.

I would encourage each of you to contact the United States Food and Drug Administration Ombudsman to lodge a complaint over the manner in which this Neupro patch release has been handled.  The FDA exists to make sure our drugs are safe and effective.  Neither one of those issues is a problem with the current Neupro formulation.  Another 24 month delay will see some of us in an unbelievable state of misery…..and THAT certainly isn’t promoting a healthy population.

If we are strong enough to fight this evil disease…we are strong enough to voice our opinions and ask the FDA to reconsider this abhorrent decision. Please write or call the Ombudsman at the FDA Center for Drug Evaluation and Research:

Address:
CDER Ombudsman
White Oak Building 51, Room 6158
10903 New Hampshire Avenue
Silver Spring, MD 20993

E-mail address: cderombudsman@fda.hhs.gov

I welcome your comments on this subject.  Bibmomma.


Filed under: Anger , Crazy people , Drug manufacturers , Parkinson's Disease , Restless Leg Syndrome , U.S. FDA Center for Drug Evaluation and Research , UCB-Schwarz Pharma Tagged: FDA Center for Drug Evaulation and Research , Neupro Patch , Parkinson's Disease , UCB-Schwarz Pharma
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