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FDA Calls for Top-Down Commitment to Quality

Agnes Shanley, Editor-in-Chief
Thursday, February 28, 2013 13:10 EST

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A.G.Raghu
A.G.Raghu  
3/14/2013 6:55:10 AM
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FDA commissioner comment is the need of the hour
Dr.Hamburg's comments on Quality Commitment is the need of the hour.It is nicely summerized in the article "FDA calls for Top down Commitment to Quality" .We have to build Quality Culture through out the organisation and this can be achieved only if there is commitment to Quality at the top. Here I recollect the words of. Philip.B. Crosby ( Quality Guru) in his book 'Completeness- Quality for 21st century'. "Quality ( meaning getting everyone do what they have agreed to do) is the skeletal structure of an organisation ; finance is the nourishment and relationships are soul. All of this comes together in what I call Completeness". These thoughts of Quality Leader Mr. Crosby is what pharmaceutical industry should move towards i.e. philosophy of Completeness. This is done by engaged senior management creates/ reinforce Quality Culture, develops involved Quality leading the team through out product life cycle. By this Quality becomes fabric of business operations. This is how we can meet the expectations of. FDA commissioner. A.G.Raghu. Santhana Gopala Consultants. Bangalore, India.

jbosavage
jbosavage  
3/7/2013 6:19:59 AM
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Re: FDA Calls for Top-Down Commitment to Quality
It is really appalling that these drugs are held to a minimum acceptable standard rather than something that inspires more confidence. In lay person's terms, do you want the surgeon who graduated top of his or her class from Harvard, or the one who just skated through a never heard from school? Both have degrees, afterall. Now, a doctor who finished top of the class from the little known (or generic) school, is likely to be a great physician -- but the one who barely passed? Not so confident in that one.

Generic drugs can save lives. We cannot afford to lose confidence in them now, especially as health care costs are soaring.

Girish Malhotra
Girish Malhotra  
3/5/2013 6:39:45 AM
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Re: FDA Calls for Top-Down Commitment to Quality
Ali:

I know the landscape. Let us be honest unless people are held accountable nothing will change. 

 

Ali Afnan
Ali Afnan  
3/4/2013 11:57:23 PM
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Re: FDA Calls for Top-Down Commitment to Quality

Girish.  You ask for sever penalties.  The fines levied by the US government on pharma companies in the last year alone add up to a staggering value.  The US follows a market economy, which means the fines become "cost of doing business".

I think 2 factors will bring about change: consumer knowledge and competition.  

At the moment we look at quality as a driver and yet we try to satisfy the minimum acceptable standard (GMP's).  In reality true business drivers are RoI, cash flow and net profits. 

Biosimilars  should prove to be a good catalyst.


Girish Malhotra
Girish Malhotra  
3/4/2013 3:20:41 PM
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Re: FDA Calls for Top-Down Commitment to Quality
Top down or otherwise quality standard has to be met first time and all the time.

How do we explain when Board of Directors of J&J exonerated managment of the company for product failures. They even got rewarded. Looser employees of the sites where the products were manufactured. 

Sever penalties are needed. We just cannot live behind recalls as they are a blank cheque to keep making mistakes. 

How long (how many years) this discussion has been going on and has the industry done anything about it. If it had we would not be talking about it. 

Ali Afnan
Ali Afnan  
3/4/2013 3:12:39 PM
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Re: FDA Calls for Top-Down Commitment to Quality

Thank you for reporting on the subject close to my heart.  The heading of the report however got my heart racing.  

 

The issue in my opinion is that we have no measurement for what Quality is.  At the same time, the regulators, the manufacturers and the consumers want quality.  And that is the beginning of the problems.

 

The consumers want quality medicines, and truly believe that FDA approved products are the gold standard.  Indeed we have, over the years, heard senior FDA staff state the "we have the highest quality pharmaceuticals possible".  Unfortunately the caveat- possible- is often misunderstood or completely ignored and hence the "gold standard" being a regulatory approval.

I wish the consumers would take a more active role in finding out how their tax dollars are spent in assuring a safe and efficacious supply of medicines.

 

I struggle with Dr Hamburg's comment. She is not wrong in making the statement, but the reality is not so easy nor perfect.  The regulations do not ask for "best quality"- they demand the lowest acceptable standard (see 21 CFR 210.1 (a)).

The issue is compounded further as we do not really know who the customer is.  Even though the patient is affected by the product, there is no direct linkage between the manufacturer and the consumer.  The voice of the customer are always the grossly failed product.  i.e. missing API does not get reported as the consumer does not know any better.  And in some cases the consumer cannot know any better.

 

Consent decrees, 483 observations and warning letters cannot be the solution even though are necessary as order must be based on reward and punishment.  Unchecked pricing- the US case- is not conducive to enhancing or improving quality either.

 

So what is the solution?  

 

I believe the only way to move industry forward is to encourage and even cajole industry  to standardization and use of consensus standards.  That will bring down prices and level the playing field.  

Standards can and will reduce the Agency's work load, allowing the workforce to become objecting auditors and abandon subjective oversight which has created a culture of individual mistrust.

 

To finish and for the record: I fully support Dr Hamburg's call for senior management to top-down quality.  I would like to ask her to top-down the Agency in the mold of CDRH and use of consensus standards.  What about replacing guidance development processes (including participation in ICH) with the transparent, open and fair practices developed by such consensus standard development organizations like ASTM?


Bikash Chatterjee
Bikash Chatterjee  
3/2/2013 9:49:24 PM
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Re: Generic Quality
Great summary Agnes and something that has been long negelected in terms of the long term impact to US healthcare form Generics. We have gotten to thsi point as a result of the industry and teh agencies inabilityt to deal withe tpricing pressure form eth emerging markets. I include the agency as culpable because of the the disaterous lack of consistancy associated with inspectiosn overseas. i personally toured a new facility in China which was slated for FDA inspection. The facility fit and finish would not compare to many of the older facilties in eth US let alone state of the aret operations. th edeisgns failed GMP in many ways and I know folks liek Hospira and Ben venue would be irate if thaey saw what was deemed accpetable outside the US. The questiosn of generic pricing is an interesting one. In Canada generics operate on a 6% margin while teh US generic industry averages 35% for normal generics and close to 85% for branded generics. I dont beleive the issue is tied to lack of financial margin to do the right thing. It is an ideological issue. Generic management ( and I agree many high profile brand manufacturers that are in trouble) have emphasized profiatbility of quality. It is an industry tht has used regulations as its basis for quality for so many years we have forgotten how to be competitive. The USP guidnaces can only be applied when eth predicate assumption of process capability exists. Otherwise pulling 6 tablets from a batch of 10, 000,000 has no validity as a release test. Th eproblesm with Generics are well documented and the FDA , perhaps with pressure from Congress looks the other way in the name of drug shortages and pricing pressure.  To move forward the thinking has to change on both ethe regulatory side na dthe busisness side if things are going to change.

Girish Malhotra
Girish Malhotra  
3/1/2013 12:49:40 PM
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Re: Generic Quality
I will defend one part of the drug. It is the API. If API was produced per spec and purity as designed, then it should perform.

However, if the formulation was not as designed, then you will have issues. My reason for the defence. API is a chemical with certain physical properties and characteristics. If there is impurity it will show up by analytical methods. Thanks.

Barry Langdon
Barry Langdon  
3/1/2013 12:22:00 PM
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Generic Quality
This is a never ending issue. I heard of two examples recently, one an Epiiepsy drug from UCB and another product from GSK where sales of their brands are holding up strongly against generics due to the risk of inefficacy of the generic versions. I saw an example close up with a blood pressure regulating drug which my mother used to take where she did not find a generic version as effective as the branded product. This should not be too surprising to chemists who have manufacturing experience and have seen the number of variables in terms of vessel size and design which can cause product variations.The causes must inevitably boil down to price pressure on generic producers.

Girish Malhotra
Girish Malhotra  
3/1/2013 11:43:55 AM
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Re: FDA Calls for Top-Down Commitment to Quality

There are few points I would like to make.

Quality should be the manufacturing company's responsibiity and NOT of the regulatory body. From my perspective, regulatory bodies are the POLICE that makes sure that companies are delivering the level of quality they have committed to deliver. Companies should not be rewarded for quality as the 2012 article suggests. Any company's reward is their profit as they are in business. The last sentence of the blog says it all: anything short is the individua company's responsibility.

Concerning the problem of API loading in generics, I would include brand drugs in this also. It may be time to tighten the confidence limit. The rule of +/- "x" percentage can be used by companies to their advantage e.g. if I can be at negative 2% from the target on a consistent basis, I have added 2% to the profit line for that drug.

API loading is individual dependent. A 5 mg drug can have different side effects on humans who are from European vs. Asian or African origin. Metabolism comes in play.

 

 

 

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