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Electronic Posting Courtesy of  BIOALERT NEWS APRIL, 1995


The">food and Drug Administration, FDA, is nearing its plans to
implement a new antibody classification ruling which will designate
numerous antibodies as Class II Medical Devices.  Many believe that
this new regulatory action will have major repercussions in nearly
every branch of biological and medical research. The FDA has started
with the regulation of antibodies used for immunohistochemistry, but
there are good indications to believe that this will expand to cover
Flow Cytometry, Hematology, Cytology and even Molecular Biology
including DNA/RNA probes.

The classification of primary antibodies as Class II Medical Devices  
was the result of a reclassification petition by the College of
American Pathologists (CAP).The meeting of the Hematology and
Pathology Devices Panel, was held in Gaithersburg, MD, on October 21,

According to previous FDA rules, these antibodies by default were
placed in Class III status. However, this was more a provisional
status than a real Device classification, and consequently never
enforced. During the Classification Panel meeting the CAP group
corroborated their support  for Class II as they had previously
petitioned. At least five other groups including  a dissident group
of  Immunopathologists within CAP itself, took a position contrary to
that of CAP and supported Class I designation.  The Joint Council of
Immunohistochemistry Manufacturers (JCIM), representing the
manufacturers, also supported Class I designation. The JCIM position
was also supported by The Health Industry Manufacturers Association
(HIMA), the largest association of the health industry with a
membership in excess of 700 health care companies. At the end of the
meeting, the official group of CAP obtained a victory, and all
primary antibodies having clinical application for
Immunohistochemistry were recommended to become Class II Medical
Devices. No provisions were made to permit the availability of these
antibodies for research use.

The  Panel Classification Meeting of October 21, 1994, was conducted
in an unconventional manner.  Apparently, during the course of the
meeting, the opinions of the delegates of JCIM were suppressed to the
extreme that their position paper was not distributed to the Panel
members.  Furthermore, the manufacturers presentation was kept under
strict time control and the manufacturers were not allowed to respond
to the arguments of CAP. In contrast, the CAP representation,
advocating  in favor of Class II, were given unlimited  time for
delivering their position and for general discussions.
This oppressive manner of conducting the meeting as well as several
other irregularities of the meeting, prompted the filing of a
complaint to the FDA by the  Washington law firm of Hyman, Phelps &
McNamara, P.C,. on behalf of the oppressed parties. Attorney Jeffrey
Gibbs, in his complaint filed with the FDA on January 9, 1995, lists
the irregularities, and cites the rules violated during the meeting.
The complaint reveals that the FDA officers present during the meeting
did not clarify to the members of CAP and the Panel members that the
requirements of safety and special controls they were pursuing to
accomplish by obtaining Class II could have been implemented even if
the antibodies were designated Class I. Essentially, The College of
American Pathologists and the Panel members  were misled by the FDA
into believing that their goals were only possible if Class II was

In the complaint, Mr. Gibbs requested that the recommendations of the
Panel Meeting  be invalidated, the meeting be rescheduled, or  the
antibodies be classified as Class I.  As of  April 10, 1995, three
months after receiving the complaint, the FDA has not officially

The significance of the outcome of this regulatory petition
spearheaded by the College of American Pathologists is that, if
designated as Class II Medical Devices, an extensive list of
antibodies both polyclonal as well as monoclonal, including CD markers,
will be subjected to an expensive process of Class II Medical Device

The manufacturers as well as distributors of these antibodies argue
that the approval cost of these antibodies will most likely be  
$20,000 to $30,000 per antibody. They believe that approximately 90%
of these antibodies do not produce sufficient sales to justify an
expenditure at such level. It is thus believed that many of these
antibodies will be removed from availability in the U.S. In addition,
all manufacturers and many pathologists assert that these antibodies,
when used for immunohistochemistry, are of low-risk to the public
and should not merit the strict regulatory environment of Class II
Medical Devices.

Upon closer examination of the products classified as Class II Medical
Devices used in clinical laboratories, we find a major difference in
the scope of regulation applied to antibodies and their auxiliary
products used for immunohistochemistry.

In the case of devices for clinical labs, the complete device is the
center of the regulatory action. For example, a kit like Hybritech's
PSA is classified as a device. This does not designate any antibody
to PSA, monoclonal or polyclonal, as a  Medical Device.  It is the
complete kit (the defined device) which is licensed under the approval
process. Therefore, the antibody by itself is not the device.
Consequently, antibodies to PSA can be made and sold as antibodies
without being an infraction to the previous FDA regulations.  
Under the new ruling, however, it is different because it  targets  
the antibodies themselves and gives no provision for the supply of the
antibodies outside of the ruling.  Under these new regulations, since
the PSA antibody has clinical significance for immunohistochemistry,
it becomes itself a Medical Device. Similarly, many other antibodies
will be under the same set of rules.

In the last two versions of the Points to Consider, a document
published by the FDA as a guide to the requirements of this ruling,
they have unexpectedly included all auxiliary reagents used in
immunohistochemistry as Class II Medical Devices.  This was
unanticipated since there was no mention or discussion on this subject
during the Panel Meeting held on October 21, 1994. Since the
classification Panel never ruled on the auxiliary reagents, it is not
understood their sudden appearance in the Points to Consider documents.  
The improprieties of this inclusion may be a separate issue but the
significance of this addition goes beyond anything expected. These
auxiliary reagents usually contain secondary antibodies labeled with
either biotin, peroxidase, alkaline phosphatase as well as conjugates
of avidin or streptavidin also conjugated to these tracers, and
chromogenic substrates of these enzymes.  This ruling designates all
of these as Class II Medical Devices. This remains an unassembled
puzzle for the manufacturers and many observers.

Overall, the number of antibodies which may be added to this list
could be considerable.  It will surely include most of the CD
antibodies available today as well as antibodies to tumor markers,
infectious agents, and practically any antibody of general importance.
This appears to be a heavy regulatory weight over a broad range of
products that are needed for general research by the U.S. scientific

Both manufacturers as well as many users fear that this will curtail
research in the US and place the US scientist at a disadvantage in
relation to their european and asian colleagues. Some independent
pathologists are disheartened with the idea of increased regulation
and fear that the prices of the antibodies will increase considerably.
In the midst of this, the prevailing official position of the College
of American Pathologists continues to support their original request
for these antibodies to be Class II Medical Devices.

Altogether, the scope of this new set of rulings led by what appears
to be a misled group of pathologists, is a difficult matter to assess.
The detrimental effect it may have on research could be substantial
and at this point it is difficult to predict if the gains of this new
move will produce benefits commensurate to the loses inflicted to
research and indirectly to healthcare. In the mind of many it is
difficult to answer, with certainty, the lingering questions: Is this
necessary? Is this really protecting the American public? Will the
net result of these new antibody regulations be beneficial or
detrimental to US healthcare?  If the scientific community does not
voice their objections effectively the FDA will continue in their
pursuit of controlling biologicals.

Whether or not the scientific community will accept the future
limitations imposed on their work by the combined efforts and ensuing
victory of the College of American Pathologists and the FDA, remains
to be seen.

Ti H. Sllubon

The text of this document  is not copyrighted. Feel free to copy and

Please, help in the distribution of this information. Scientists
should be aware of this pending problem.  If you have a computer with
telecommunication capabilities, download this document and post it to
any Life Sciences newsgroups including Medicine.  Post under the

If you get a hardcopy of this document circulate to all scientific
staff at your institution.

Tue, 14 Oct 1997 03:00:00 GMT
 [ 1 post ] 

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