Any User 00useran at wave.scar.utoronto.ca
Fri Jul 5 11:37:46 EST 1996

eresrserserserserserserJames Stiehr <jstiehr at bioreagents.com> wrote:
>Bryan Kiehl wrote:
>> It is my understanding that the FDA does now require that reagents
>> that may be used for diagnostic uses (e.g., cancer markers, infectious
>> disease detection, etc.) are to be regulated.
>> However, it also appears the amount of regulation is minimal. They
>> require that the manufacturer follow good manufacturing practices.
>> These include proper labeling and documentation during the
>> manufacturing processes, as well as being able to field customer
>> complaints and document how you deal with these. The regs also require
>> that the company submit a notifcation with proposed labeling before
>> marketing the product. This is then reviewed by the FDA for truth and
>> accuracy.
>> For example, is the reagent is an antibody, then one must identify
>> what the antibody recognizes and be sure that all claims are accurate.
>> If this is only a reagent and not a kit, there can be no performance
>> claims. These reagents are intended for the user to establish the
>> assay method. The user (e.g., pathologist, laboratory) must "validate"
>> that the assay using this reagent performs well enough for diagnostic
>> uses. The end user must also assure continued performance.
>> If the manufacturer puts the reagent into kits or claims diagnostic
>> performance, then he needs to provide data to the FDA. Otherwise, he
>> mostly needs to just assure that the reagents are made well and
>> packaged without error.
>> For most smaller companies this may seem a burden at first, but
>> similar regs are being established in Europe under ISO regs.
>Since many of the companies which provide reagetns are small companies, 
>it becomes a major issue.  Look in linscott's directory, you don't see 
>many large companies with the deep pockets necessary to manage these 
>regulations.  GMP sounds nice and easy, but if you look at the actual 
>requirements, they are not trivial.  If people would like to see it, I 
>would be happy to add it to the web site that has been created for this 
>purpose:  http://www.earthnet.net/~affinity/fda. 
>> I also doubt that true research reagents that are never or rarely
>> used in the clniical realm will ever be regulated. Remember, the FDA
>> can only come down on a company that sells these reagents to groups
>> that really do use them for human diagnostics.
>It is unfortunate that a company cannot decide for itself that it does 
>not want to be a diagnostic company and offer "dual use" products which 
>can be identified as not appropriate for diagnostic use.  There are 
>federal consumer laws making it illegal to use a proguct contrary to its 
>labeled use, however, pathologists (and other physicians) have managed to 
>exempt themselves from these laws.  Unfortunately, this leaves the 
>supplier responsible for the use of its product.  When you consider that 
>most research reagents are sold to universities and ordered through the 
>purchasing dept. to be delivered to "receiving" how can a company know 
>who and how its product is used?  
>What about the situation where today we sell a product that is not 
>clinically relevant, but a paper comes out tomorrow saying it is?  In 
>that case, we have developed a market for a "true research reagent' that 
>is discovered to have a new application.  We still don't want to be a 
>diagnostic company, yet at that point, according the the regs. we're 
>selling an IVD and must therefore either conform to the regs and incur 
>all of the marginal expenses for that single antibody (most of which only 
>sell $5000-$10,000/year) or remove them from the market.
>Why can't we all be responsible suppliers and consumers (shades of Rodney 
>King).  If FDA, CLIA, suppliers and consumers could all agree to 
>recognize that a product labeled "For In Vitro Experimental Use Only, Not 
>for Diagnostic Use" really should not be used in any kind of clinical 
>setting, then these would not need to be regulated by FDA.  If CLIA found 
>pathologists using them in their lab, sanctions could be applied.  If FDA 
>found suppliers promoting them for clinical use, appropriate disciplinary 
>action could be taken.  Honest companies who supply the research market 
>with important research tools could go about their business either making 
>quality products which their customers are happy with or going out of 
>business if they are not - no harm done to anyone.
>James Stiehr 
>Affinity Bioreagents, Inc.

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