James Stiehr jstiehr at bioreagents.com
Wed Jul 3 10:38:29 EST 1996

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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