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How Would You Solve the Sterile Injectable Generics Crisis?

Agnes Shanley, Editor-in-Chief
Wednesday, February 27, 2013 01:00 EST

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ALM at Global B2B
ALM at Global B2B  
4/12/2013 12:21:55 PM
User Rank Cultural Capitalist (Black Belt)
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zen and the art of motorcycle maintenance and sterile injectables
If and when we all drill down to any discussion of "quality" in pharma or any arena in life, it's clear that the ethos of questing for quality is on the same path as Sysyphus.  

Alas, we live ina world where the search quality for quality sakes is rare.

If we are going to look at incentives, let's look from top (C-level) to bottom line workers all and see how much or how little thy are rewarded for walking that extra mile or milllimeter to ensure quality is king.  

Have we read many headlines about executives getting bonuses tied to quality instead of bottom lines?

ALM at Global B2B
ALM at Global B2B  
4/12/2013 12:21:53 PM
User Rank Cultural Capitalist (Black Belt)
50%
50%
zen and the art of motorcycle maintenance and sterile injectables
If and when we all drill down to any discussion of "quality" in pharma or any arena in life, it's clear that the ethos of questing for quality is on the same path as Sysyphus.  

Alas, we live ina world where the search quality for quality sakes is rare.

If we are going to look at incentives, let's look from top (C-level) to bottom line workers all and see how much or how little thy are rewarded for walking that extra mile or milllimeter to ensure quality is king.  

Have we read many headlines about executives getting bonuses tied to quality instead of bottom lines?

Bowman Cox
Bowman Cox  
3/8/2013 3:48:16 PM
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Woodcock: Metrics would enable GPOs to choose quality generics
As Dr. Woodcock explained in a recent interview with "The Gold Sheet," FDA's quality metrics initiative mainly would help hospitals obtain a more reliable supply of sterile injectables by providing their group purchasing organizations with tools to evaluate manufacturing quality when making contracting decisions.

The lesson FDA apparently drew from the drug shortage crisis is that by forcing manufacturers to compete on price but not on quality, GPOs drove prices to unsustainably low levels, eventually precipitating major GMP breakdowns and shortages. It will be interesting to see if the industry agrees with FDA's interpretation.

See the story in "The Gold Sheet" here.

 

Hedley Rees
Hedley Rees  
3/7/2013 4:38:44 AM
User Rank Blogger
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Not a good idea!
This is a very dubious route to take, for many reasons. Have you every been to a 4 star hotel and found it had been rated 3 years ago and things had gone seriously down hill since....

I think Dr Woodcock should go back to her 2004 request for LESS regulatory oversight - this is potentially going to muddy the waters in a big way.....if it comes to fruition. Hopefully they will see sense beforehand and focus resources on more enforcement activity to complement the regulatoins.

 

Iqbal Khan
Iqbal Khan  
3/4/2013 5:42:12 AM
User Rank Survivor (White Belt)
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Re: solution is easy.
Hello all,

The most comments, I have read here are irrelevent. my opinion was keeping safety and quality constant. The standards which are set by FDA are on the basis of different studies. One can object but can't deny. The truth is that these standards are accepted.

 

Thanks

Iqbal Khan
Iqbal Khan  
3/4/2013 5:28:28 AM
User Rank Survivor (White Belt)
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Re: solution is easy.
Ya this is an addition to my suggestion but more breif and comprehensive

thank you

angelodp
angelodp  
3/3/2013 10:20:48 AM
User Rank Survivor (White Belt)
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quality and reward
It's difficult to know what Woodcock means by quality. Is the product safer? More effective? Or is she referring to regulatory surrogates for quality that may or may not have anything to do with the disposition of the product in the body? The NY Times report on this subject refers to the compounding pharmacy disaster, but these companies do not operate under GMPs to my knowledge.

Woodcock also refers to "rewarding" quality, but how can this be achieved other than by market presence? Drugs are not like foods, where consumers make their individual quality decisions based on subjective (and sometimes objective) criteria. Drug quality is defined more in the breach than in the observance.

Agnes Shanley
Agnes Shanley  
2/28/2013 11:28:50 AM
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Re: solution is easy.
Thanks for writing in.  Taking this discussion to a much broader level, FDA is soliciting public opinion on potential solutions. Please send comments to the Federal Register


Simon Veysey
Simon Veysey  
2/28/2013 9:03:50 AM
User Rank Survivor (White Belt)
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Re: solution is easy.
Quality is not just about money although investment in the right equipment and facilities is vital. The people are the key to this. You can not beat experience and understanding of processes and also what the final product is for. Investment in people and training should be high on the list. It is all too common for people to assume that RABS and isolators mean that the product is safe from contamination. Have good procedures and follow them.

Charles Butcher
Charles Butcher  
2/27/2013 1:02:19 PM
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Re: solution is easy.
 

@aureusaqua: "I suspect it will be illegal as it categorize what is have to be sefe and effective which can give wrong message about safety and effectiviness."

I'm not sure about that. Perhaps "safe" and "safe plus" would work. An analogy: here in the UK we have a legal minimum hourly wage, but it's widely thought not to be enough to live on. Recently the idea of a slightly higher "living wage" has gained some support among employers as well as workers. I can't see the healthcare industry on its own wanting to pay for quality above what they have a right to expect is safe, but perhaps public pressure for "safe plus" would work.

 

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