UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported): October 16,
2010
AMERICAN BIO MEDICA
CORPORATION
(Exact
name of registrant as specified in its charter)
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New York
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0-28666
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14-1702188
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(IRS Employer
Identification Number)
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122 Smith Road, Kinderhook,
NY
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12106
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: 518-758-8158
Not
applicable
(Former
name or former address, if changed since last report.)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see
General Instruction A.2. below):
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
8.01 Other Events
On
October 16, 2010, American Bio Medica Corporation (“ABMC”) voluntarily and
temporarily suspended marketing and sale of its oral fluid drugs of abuse
products in the workplace market. This decision on the part of ABMC was made in
response to communications and interactions with the U.S. Food and Drug
Administration (“FDA”) over the course of the last several months.
In July
2009, ABMC received a warning letter from FDA, which alleged that ABMC was
marketing its point of collection oral fluid drug test, OralStat®, in workplace
settings without marketing clearance or approval. Workplace and Government are
ABMC’s primary markets, and it has been ABMC’s belief (based on advice from
legal counsel) that marketing clearance from FDA is not required to sell ABMC
drug tests in non-clinical (i.e. non medical) markets (such as workplace and
criminal justice/law enforcement), but is required to sell ABMC products in the
clinical and over-the-counter (consumer) markets. ABMC does not sell its oral
fluid drug tests in clinical or over-the-counter (consumer) markets. In
addition, there are many other oral fluid point of collection drug tests
currently being sold in the workplace market by ABMC competitors, none of which
have received FDA marketing clearance.
ABMC has
communicated to FDA its belief that marketing clearance is not required in
non-clinical markets; and that such belief is based upon legal advice from ABMC
counsel. To date, FDA does not agree with ABMC’s interpretations of FDA
regulations related to medical devices, and FDA continues to assert jurisdiction
of drug testing performed in the workplace. Although ABMC does not concede that
FDA has jurisdiction over drug testing when performed in the workplace, ABMC has
informed FDA that ABMC is willing to file a marketing clearance application,
however, ABMC has also communicated to FDA that specific technical and
scientific e issues exist when attempting to utilize FDA’s draft guidance
related to oral fluid point of collection drug tests. More specifically, that
technical and scientific issues exist when trying to use the draft guidance for
oral fluid drug tests because the draft guidance was written for urine drug
tests. Although ABMC has met with FDA, to date, FDA has not provided the
additional guidance ABMC has requested regarding the issues
identified. This has impacted ABMC’s ability to collect the data need
to obtain marketing clearance, however ABMC continues to move forward with its
efforts to collect the necessary supporting data and to obtain marketing
clearance.
The cost
of obtaining marketing clearance could be material and incurring such cost could
have a negative impact on ABMC’s efforts to improve its performance and to
achieve profitability. Furthermore, there can be no assurance that ABMC will
obtain marketing clearance from FDA, especially since ABMC would be the first or
one of the first companies to apply for such marketing clearance. ABMC’s point
of collection oral fluid drug tests currently account for approximately 20% of
ABMC sales; if ABMC continues to be unable to market and sell its point of
collection oral fluid drug tests in the workplace market, this will negatively
impact ABMC revenues.
Although ABMC is currently unaware of
any additional changes in regulatory standards related to any of its markets, if
regulatory standards were to further change in the future, there can be no
assurance that FDA will grant ABMC appropriate marketing clearances required to
comply with the changes, if and when ABMC applies for them. ABMC will continue
to take the necessary actions that will enable ABMC to submit a marketing
clearance application to FDA, and/or any additional actions that may be required
to address the jurisdictional question raised by ABMC counsel.
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly
authorized.
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AMERICAN
BIO MEDICA CORPORATION (Registrant)
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Dated:
October 21, 2010
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By:
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/s/ Melissa A.
Waterhouse
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Melissa
A. Waterhouse
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Vice
President & Chief Compliance Officer
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Corporate
Secretary
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