NATIONAL ON-SITE TESTING ASSOCIATION

WRITTEN COMMENTS REGARDING FDA DRAFT GUIDANCE FOR

PREMARKET SUBMISSION AND LABELING RECOMMENDATIONS FOR DRUGS OF ABUSE
SCREENING TESTS

MARCH 1, 2004

FDA DOCKET NO. 2003D-0522

CONTACT PERSON:

David G. Evans, Esq.

Executive Director

> National On-site Testing Association

203 Main St.

PMB 193

Flemington, NJ 08822

> **908-284-5080**

Number range CHAPTERFDA REGULATION OF ON-SITE DRUG TESTS WILL RESULT IN
AN INCREASE IN ILLICIT DRUG USE AND IN HARM TO PUBLIC HEALTH AND SAFETY
AND THE FDA DOES NOT HAVE JURISDICTION OVER NON-MEDICAL USE OF DRUG
TESTS

On-site drug tests are currently in use throughout the United States,
for use in the workplace, for sports testing, for schools, for insurance
analysis, and numerous other non-medical applications. These tests are
safe, accurate, cost effective, and easy to use. The FDA is seeking to
regulate the non-medical use of these tests, however, the FDA only has
jurisdiction over the medical use of such tests.

### Workplace Uses 

Various non-medical and/or non-diagnostic reasons have been given by
employers for drug testing of applicants or employees. The courts have
upheld the following reasons for employment drug testing:

Promoting workplace efficiency and reducing employer costs associated
with drug abuse;

Ensuring the integrity of employees;

Promoting public confidence in the safety or integrity of a particular
job;

Prevention of theft;

Prevention of blackmail;

Promoting co-worker morale;

To corroborate evidence of misconduct;

To prevent embarrassment to the employer;

Discouraging illegal or immoral conduct by employees;

To promote a drug free society; and

To gather facts about employee drug use and operational efficiency.

[None of the above reasons include a diagnosis or treatment of
disease]{.underline}.

### Other Non-diagnostic Uses 

A product that is used by law enforcement to determine compliance with
the law will not come under the FDA regulation. For example, alcohol or
drug tests for the illegal presence of alcohol or other drugs in the
body of a driver of a motor vehicle are not intended to diagnose a
disease. Drug and alcohol test devices that are used with the intent of
furthering school discipline or to monitor athletes or other purposes
that do not relate to diagnosis of a medical disease or condition do not
come under the FDA\'s authority. The availability of these
non-diagnostic drug and alcohol tests is essential to the freedom that
consumers must have to make choices as it relates to compliance efforts.
It is a distortion of the lawful definition of the term \"device\" to
claim that the FDA can regulate drug and alcohol tests that are intended
to be used for compliance for societal and law enforcement purposes.

### What Problem is the FDA Trying to Address?

This type of testing has been, and is being, employed effectively and
satisfactorily throughout the United States. There is not any
significant need, or identified problem, arising from either the subject
class or the testing class, that would indicate that any purpose would
be served by FDA regulation of these products.

Examples abound of employers and national organizations that have used
this type of on-site drug testing (without any apparent deficiencies
resulting from the absence of regulation). They include:

The United States Postal Service (hundreds of thousands of tests per
year)

The United States Administrative Office of the Courts

A & P Stores

Ford Motor Co.

Conagra

Tyson Chicken

Iowa Beef Packers

Oscar Mayer

Florida Dept. of Law

Coca-Cola

Hershey Chocolates

Family Dollar Stores

Walmart

K-Mart

Supervalue Stores

Brown and Root Construction Co.

Snelling Personnel Services

Healthcare Security Services

C.G. Financial Services

U.S. Navy Drug Screening Lab

Naval Hospital Camp Pendleton, CA

American University-Justice Program Office

US Dept of Justice

Sarasota Drug Court

The Salvation Army

Vangaurd Security

Union Carbide Corp

Armour General Offices

Leclede Steel Company

Swift & Company

Initial Security

McDonalds Food Center

Total Risk Management

Proctor&Gamble

Georgia Pacific

American Sub Contractors Assoc.

Manpower, Inc.

Ingalls Shipbuilding

Fire Control Systems, Inc

Holiday Inn & Casino

Worldwide Protection Group

Suffolk District Court

Russell Stover Candies

U.S. Marine Corp. Recruiters

Kohler Co.

Oscar Mayer

Toys R Us, CA

Kids R Us, CA

Disaster Recovery Service

Raytheon Engineers and Construction

Navy Recruiting

### 

### The Guidance is Unduly Burdensome

The most immediate result of the implementation of the proposed
Guidelines will be the significant increase in the cost of the test
products at every level. The real weight of any cost increases will most
greatly impact those smaller organizations such as schools that have
only marginal ability to fund optional implementation. These smaller
entities will be forced to confront the elimination or the scaling back
of testing, and those entities that are considering implementation will
be dissuaded from such future and avoidable costs of implementation.
Schools will be hard hit. Very often cost is the controlling factor in
deciding to implement student drug testing. President Bush in the State
of the Union Address stated that student drug testing is a goal of the
administration. In his recent national radio address he mentioned the
student drug-testing program at Hunterdon Central High School in New
Jersey as a model program. They use an on-site drug test.

The proposed Guidance standards for administration of on-site test are
unnecessary and intrusive. On-site drug tests are currently administered
with no discernable administration problems that cannot be solved by
brief training. A cursory examination of on-site drug tests, urine or
saliva, reveals that these tests are self-evidently simple to use, and
easily administered by even a first-time user. It remains unclear what
defect or problem in administration is being addressed or corrected by
the proposed Guidance. Furthermore, to the extent that any regulatory
oversight may be appropriate, those concerns are, and have been
addressed by existing agency standards and practices already established
by DOT and SAMHSA. The FDA Guidance creates a redundancy of regulatory
compliance issues which: (a) further increases compliance cost, and (b)
highlights the duplicative and unnecessary character of this Guidance.

By contrast, Breathalyzer testing is far more complex than on-site drug
testing products, and yet the FDA exercises no oversight. Alcohol breath
testing has been successfully deployed for decades in the workplace and
in schools. It employs truly complex machinery, requiring trained
administration. And, in the law enforcement context, the ramifications
for the test subject are more severe than the ramifications of
employment drug testing. Yet FDA seeks to regulate the far simpler
on-site tests. FDA does not explain or provide a rationale for its
decision to apply greater regulatory scrutiny to the simpler and
easier-to use on-site drug test products.

Also problematic is the fact that the FDA Guidance does not appear to
address the current state of on-site testing technology. FDA appears to
presume or imply that all on-site tests deliver inferior performance to
initial lab tests, an implication which is unfounded. Many on-site tests
produce results equal to the results obtained from initial lab testing.

# 

# The FDA Proposed Labeling Requirement is Unrealistic

The FDA Guidance has labeling requirements that indicate the FDA does
not know how these tests are used or how people are trained to use them.
The proposed Guidance will require that a lay user receive training from
a "qualified health care worker." The tests do not require a health
worker to provide the training. The manufacturers do that and they do it
quite well. There are hundreds of thousands of these tests being
performed each year in a variety of settings. Lay users who have been
trained by the manufacturers perform virtually all the tests used in
criminal justice or the workplace. Has the FDA received many complaints
about test administration? If so, we would like to review them

The labels suggested by the FDA use data that is the most negative data
on on-site tests. We want the FDA to share these data sources with us.
We have data we would like to present to the FDA showing how accurate
the tests are.

## The Guidance Will Result in an Increase in Drug Use

Testing has proven to be one of, if not [the]{.underline} most effective
deterrent to drug use. The unavoidable decline in the continued and new
deployment of on-site drug test products as a result of implementation
of the FDA Guidance will inevitably result in resurgence in illicit drug
use, mostly in the workplace. If the Guidance is implemented, on-site
drug testing will become a costlier and more burdensome process. Many
smaller companies which would otherwise have considered implementation
of on-site testing will opt not to devote resources to what will have
become a more expensive and compliance-problematic procedure. Certain
companies with existing drug-testing procedures will decide to abandon
testing. Therefore, one of our most effective deterrents to drug use
will be abandoned by, or be put out of reach of, a large segment of the
potential or existing drug-test market. The inescapable result will be
an increase in illicit drug use in the workplace, and in any other areas
where simple on-site drug testing will have become too costly or
burdensome for implementation. The increase in drug usage will mean
higher rates of workplace accidents and injury, and higher costs to
businesses in terms of lost productivity.

All of the aforementioned threats to the public welfare might be
justified if there were some articulated benefit to be gained by the
proposed Guidance. It remains unclear what the ostensible benefit is to
be. As it is, and absent some significant counter-balancing beneficial
aspect, the ultimate effect of the implementation of the FDA Guidance
will be an increase in illicit drug use, particularly in the workplace,
and an across-the-board negative impact on public health and safety. At
this juncture, the best way for FDA to foster and preserve the public
health and safety would be to abandon the proposed Guidance, and leave
in place the current wide-spread system of long-standing,
well-functioning, and constantly improving on-site drug testing.

## THE FDA DOES NOT HAVE JURISDICTION TO REGULATE ON-SITE DRUG TESTS 

There is basis for a cognizable claim against FDA's drug testing
regulations to enjoin its actions as extra-jurisdictional.[^1] It is the
product's entirely [non-medical]{.underline} use (both intended and
actual), that sets it beyond the historical and statutory boundaries of
FDA's jurisdictional authority. While the Courts have rarely acted to
reign in FDA's expansion of scope, the "medical use" requirement, while
stretched, has remained a constant. One exception to this limitation
occurred in a 1994 decision in [Clinical Reference Lab v.
Sullivan]{.underline}, 21 F.3d 1026 (CA 10). This case ("CRL") is
distinguishable, and is discussed herein, below.

**A. The Standard of Review**

In [Chevron USA, Inc. v. National Resources Defense Council,
Inc]{.underline}., 467 US 837 (1984), the Supreme Court established a
two-pronged test for reviewing an agency's statutory interpretation:
first, courts should accept agency interpretation of its organic statute
if said interpretation accords with the unambiguously expressed will of
Congress. Second, if Congress was silent or ambiguous, deference should
be given to any agency interpretation which is not arbitrary, capricious
or manifestly contrary to the statute. In [NLRB v. United Food &
Commercial Workers Union]{.underline}, 484 US 112 (1987), the Supreme
Court noted that the first prong of the [Chevron]{.underline} test does
not in fact involve any deference, in that determining congressional
intent is a purely legal question, to be guided by traditional rules of
statutory construction. [NLRB]{.underline} at 123. (See also: [INS v.
Cardoza-Fonesca]{.underline}, 480 US 421, 446-448 (1987), noting that
[Chevron]{.underline} deference does not apply to questions of pure law,
such a interpretation of legislative intent and primary construction of
the statute, and is most appropriate in questions of application of
facts to law).

In [United States v. 25 Cases, More or Less\....Sensor Pad]{.underline},
942 F.2d 1179 (CA 7 1991), the court, discussing the scope of FDA
jurisdiction, noted that [Chevron]{.underline} deference might not apply
to an agency's interpretations of its own jurisdiction.
[Id]{.underline}. at 1182. [Chevron]{.underline} deference is properly
applied when examining the "wisdom of an agency's policy," but when
reviewing an agency's actual power to act - a question of law - the
court is to accord no deference to the agency's litigation position, but
rather should employ its own judgment. [INS v.
Cardoza-Fonesca]{.underline}, at 446-448.

Professor Cass R. Sunstein, in "Law and Administration After
[Chevron,]{.underline}" 90 [Columbia Law Review]{.underline} 2071 (1990)
explains that one of the apparent limitations on [Chevron]{.underline}
is that it does not apply to agency interpretations of its own
jurisdiction. Deference in jurisdictional matters would effectively
leave agencies without any controls over their exercise of power.
[Id]{.underline}. at 2097-2101. The Administrative Procedure Act appears
to confirm this viewpoint, requiring agency actions "in excess of
statutory jurisdiction" to be unlawful. 5 USC 706 (1988).

Congress and the courts have long noted that the remedial purpose of the
FDCA requires liberal interpretation. Nevertheless, Congress has left a
clear record of its concerns regarding FDA's potential, in light of its
acutely important function, for wanton expansion of its powers, and its
danger of attempting to regulate "well nigh everything in creation." 122
[Cong. Record]{.underline} 5851. From the inception of the FDCA and
throughout its modifications, the congressional record and intent has
clearly been to cover only articles with intended therapeutic use or
effect. FDA's interpretation of FDCA 201(h) \[21 U.S.C. 321(h)\] to
include nonmedical in vitro articles, such as on-site testing kits,
cannot meet the first prong of the [Chevron]{.underline} test, since
such an interpretation is contrary to the "unambiguously expressed
intent of Congress" that FDA medical device jurisdiction be limited to
articles with intended therapeutic use or effect. (See:
[Chevron]{.underline}, at 842-43).

Most significantly, an agency is not permitted to change or reverse
course on a longstanding interpretation of its enabling statute without
adequate explanation. [NLRB v. Bell Aerospace Co.]{.underline}, 416 U.S.
267, 289 (1974). As demonstrated below, FDA has a longstanding policy
that its jurisdiction extends only to those devices with medical usage.
Furthermore, FDA's consistent interpretation of FDCA has been that
biometric items (e.g., in vitro testing) intended for use in obtaining
information for non-medical purposes are not medical devices under the
Act. By reversing its interpretive course, FDA is exposed to judicial
scrutiny, wherein it must either adequately explain its change of
course, or revert to its original interpretive policies. See, e.g.:
[United States v. Diapulse Corp. of Am.]{.underline}, 748 F.2d 56, 60-62
(2^nd^ Cir. 1984), (stating that FDA's failure to provide a reasonable
explanation for its inconsistent actions was proper grounds for
modifying a permanent injunction to allow the defendant to market its
products); [Rhodia, Inc. v. FDA]{.underline}, 608 F.2d 1376, 1379 (D.C.
Cir 1979) (FDA regulatory actions must be based on a legitimate and
rational basis [consistent with prior practices]{.underline}.); Greater
[Boston Televison Corp. vv. FCC]{.underline}, 444 F.2d 841, 852 (D.C.
cir. 1970) (an agency must provide "reasoned analysis indicating that
prior policies and standards are being deliberately changed, not
casually ignored"); [U.S. v. Undetermined Quantities of an Article of
Drug..Exachol]{.underline}, 716 F. Supp. 787, 795 (SDNY 1989) (requiring
FDA to apply statutory and regulatory interpretation in consistent,
evenhanded manner.)

Because Congress, and FDA itself, has historically drawn a
jurisdictional line between medical and non-medical uses of products
under review, the courts must hold FDA to that established distinction.
Even if FDA were to provide its analysis and rationale for its change of
course, a court may reasonably refuse to allow the jurisdictional
expansion solely on the basis of congressional intent under the
[Chevron]{.underline} analysis.

**B. FDA And Congress Have Historically and Consistently Required**

**That a Product Have A Medical Purpose or Effect in**

**Order to Fall Within FDCA Jurisdiction**

FDA jurisdiction extends to any article that qualifies as a "device"
under the FDCA. Under Section 201(h) of the FDCA \[21 U.S.C. 321(h)\],
FDA's authority over "devices" is explicitly contingent upon the
"intended use" of the device. The statute provides:

> The term "device"\...means an instrument, apparatus, implement,
> machine, contrivance, implant, in vitro reagent, or other similar or
> related article, including any component, part or accessory, which is-
>
> \(1\) recognized in the official National Formulary, or the United
> States Pharmacopoeia, or any supplement to them,
>
> \(2\) intended for use in the diagnosis of disease or other
> conditions, or in the cure, mitigation, treatment, or prevention of
> disease, in man or other animals, or
>
> \(3\) intended to affect the structure of any function of the body of
> man or other animals..

During development of the 1976 Medical Devices Act (which produced the
current Section 201(h) definition), Peter B. Hutt, Assistant General
Counsel, Food Drugs and Product Safety Divisions of FDA, wrote: "The
term 'device' as reflected by the legislative hearings, was intended to
cover both quack machines and legitimate articles like trusses,
ultraviolet lights, orthopedic shoes, surgical instruments,
contraceptives, prosthetic devices and similar articles." Clearly, FDA
at that time considered that "intended therapeutic purpose or effect"
was to be the touchstone of 201(h) jurisdiction. Since enactment of the
Medical Devices Act, the FDA has consistently acknowledged and abided by
the "therapeutic purpose" requirement. At 48 Federal Register 53,032,
53.044 (1983) the FDA noted that consumer articles such as sports
equipment, canes, wheelchairs, etc., are regulated as "therapeutic
equipment" when "[intended for medical purposes]{.underline}," but not
when intended for recreational or exercise uses.

Similarly, a doctor's scale would be considered a "device" under the
FDCA, but a standard consumer bathroom scale would not. A tuning fork
used to diagnose a hearing disorder would be a "device" while a tuning
fork sold at a music store would not. Therefore, a similar, or even
identical, item could fall within or outside of FDA jurisdiction based
solely on its intended use. Nor was the FDCA intended to reach every
product used by a physician, but only those intended by the manufacturer
for therapeutic use. In preliminary discussions at the inception of the
FDCA, the FDA stated categorically that an article, like a
chiropractor's table, would not be regulated under the FDCA, unless the
manufacturer were to "say that \[the\] table would cure various ills."
(See: FDCA Hearings on S. 2800 before Senate Comm. on Commerce, 73 Cong.
2d Sess. 516-17 (1934).

Under 21 C.F.R. 809.3(a), in vitro[^2] diagnostic products are defined
as "those \[products\] intended for use in the diagnosis of disease or
other conditions, including a determination of the state of health, [in
order to cure, mitigate, treat or prevent disease or its
sequelae.]{.underline}" The FDA's own regulations therefore explicitly
require that a "medical purpose" be present in order to meet its
definition of an in vitro diagnostic product. FDA has consistently
maintained this "medical use" requirement when determining whether an in
vitro product would constitute a "device" under the FDCA.

In an FDA Regulatory Letter dated January 13, 1983, the Director, FDA
Center for Devices and Radiological Health, concluded that insurance
company screening of applicants' saliva for nicotine, to verify
statements regarding tobacco use, is not a medical use, and
consequently, the devices were not medical devices under FDA section
201(h) jurisdiction, writing: "[Although this product is used as an in
vitro diagnostic reagent, if it is not intended or promoted for a health
or medical use or purpose, we would not regard it as a medical
device]{.underline}." Similarly, Kathleen Shanahan, Division of
Compliance Operations, FDA Center for Devices and Radiological Health,
in a November 22, 1988 regulatory letter, stated that articles used in a
non-medical setting, such as an article used by police to show
intoxication, are not medical devices (If, however, they were sold to
hospitals or clinics for the treatment of alcoholism, they may be within
the scope of the statute). A third letter, from Arthur McIntyre
(Division of Small Manufacturers Assistance, FDA Center for Devices and
Radiological Health, discusses a test which would detect alcohol in
saliva, and states: "Section 201(h) of the FDCA defines medical devices
to include in vitro reagents intended for use in the diagnosis of
disease or other conditions. [Although the test discussed does identify
a condition, if it is not intended or promoted for a health or medical
use or purpose, it would not be considered a medical
device]{.underline}."

It is therefore indisputable, and inescapable, that FDA has a
well-defined and well-documented position regarding the requirement of
"medical purpose" in order to assert its jurisdiction over in vitro
diagnostics. FDA's position explicitly indicates that 21 C.F.R. 809.3(a)
"in vitro diagnostic product" definition is congruent with FDCA Section
201(h), in requiring a medical purpose or intent in order for the item
to be a "device" under the FDCA. This position therefore clearly
excludes on-site workplace drug test kits from FDA jurisdiction.
Insurers and employers use on-site drug testing for a number of sensible
economic reasons, having nothing to do with the tested individual or his
treatment, but rather for the intended purpose of providing the employer
(i.e., the test[er]{.underline}) with information, in order that the
employer may make informed decisions regarding productivity and safety.
Both the intended and actual use of such products is for business and
economic reasons, and is exclusive of any therapeutic purposes.

Congress has made itself clear regarding the issue of whether drug
testing constitutes a medical use, stating in the context of the ADA ["a
test to determine the illegal use of drugs shall not be considered a
medical examination]{.underline}." 42 U.S.C. 12114(d)(1). Our courts
seem to agree, consistently holding that drug test do not provide any
basis for a medical evaluation of disability or illness. [Copeland v.
Philadelphia Police Dept.]{.underline}, 840 F.2d 1139 (3^rd^ Cir. 1988),
cert. den. 109 S. Ct. 1636 (1989); [McLeod v. Detroit]{.underline}, 39
FEP Cases (BNA) 225 (E.D. Mich 1985). Therefore, Congress, the Courts,
and until recently, the FDA, all agree that workplace drug tests do not
fall within the scope of the FDCA.

Using drugs illegally does not mean that you are ill or an addict. All a
drug test does is show drug use, not illness. If the FDA declares that a
drug test is a medical examination this will cause untold complications
for employers and schools that rely on these tests to protect employee
and student safety.

The information provided by such tests is of value only to the test
administrator: it is intrinsic in such testing that the test subject
himself cannot learn any medical information from the test results that
he does not already know. If he is using illegal drugs he already knows
that. Therefore, the subject's own medical situation or knowledge cannot
be altered or affected by the test results.

**C. The Clinical Reference Lab Case ("CRL")**

In [Clinical Reference Lab v. Sullivan]{.underline}, 21 F.3d 1026
(10^th^ Cir. 1994) the Tenth Circuit held that the FDA statutory
authority allowed jurisdiction over any diagnostic in vitro testing,
regardless of the existence of any medical or therapeutic use. There are
two reasons to believe that a different federal circuit might not follow
the CRL precedent. First, it was not a unanimous decision; one of the
appellate judges was of the opinion that FDA lacked the jurisdiction at
issue. Second, the opinions themselves, at both the district and
appellate levels, did not follow the established Supreme Court precedent
for the review of an agency's interpretation of its own jurisdiction. A
different federal court could reasonably decline to follow CRL.

FDA sought to expand its jurisdiction over non-medical biometrics in
[Clinical Reference Lab v. Sullivan]{.underline}, 791 F. Supp. 1499 (D.
Kan. 1992); aff'd in part, rev'd in part, 21 F.3d 1026 (CA 10). FDA
argued that in vitro biometric articles used in insurance risk analysis
are medical devices. Specifically, FDA sought to regulate the urine
specimen collection devices used in laboratory testing (screening) for
presence of HIV in insurance applicants. The results were intended for
use by the insurance company, not the applicant. Because there was no
medical purpose for the test itself, FHA based its argument on the
possibility that applicants themselves could discover the test results,
and might place detrimental [medical]{.underline} reliance on the result
of such testing.[^3]

The district court agreed, finding that the applicants' speculative and
subjective medical use of the test results controlled, regardless of the
test's objective non-medical intended purpose. The court turned the
explicit statutory "intended use" requirement on its head, stating,
"intended use may also be shown by the product's actual use." (Citing:
[US v. 22 Rectangular Devices]{.underline}, 714 F. Supp 1159, 1165 (D.
Utah 1989). But here the [actual]{.underline} use was the non-medical
insurance purpose - the only arguable "medical" use was a speculative
and hypothetical mis-use of the product. This was not what was intended
by the precedent cited by the court regarding "actual use."

The court acknowledged that CRL's products "are used with the express
purpose of obtaining insurance, and only indirectly, through possible
misplaced consumer reliance on the tests as an AIDS/HIV detection
procedure, are the products used to determine the need for medical
treatment." The court announced that it could find "no indication,
however, that this distinction makes a difference." [Id]{.underline}. at
1507. In so finding, the court ignored years of FDA policy requiring
objective medical purpose or use (see discussion above). The court's
finding also contradicted FDA's own pleadings, in which FDA conceded
that a device which has no medical application could not qualify as a
device under the FDCA (See: [CRL]{.underline}, 21 F. 3^rd^, at 1030).

On appeal, the Tenth Circuit further found that the 21 C.F.R. 809.3(a)
definition of in vitro diagnostic products, which explicitly covers only
those products whose diagnostic uses are conducted [in order to cure,
mitigate, treat or prevent disease or its sequelae]{.underline}, was not
controlling, and that non-medical use of such products could be
regulated under the 21 USC 321(h)(2) "device" definition.

Section 201(h) of the FDCA \[21 U.S.C. 321(h)\] provides that a
"device"\...means an instrument, apparatus, implement, machine,
contrivance, implant, [in vitro reagent]{.underline}, or other similar
or related article." To define "in vitro reagent" we turn to 21 C.F.R.
809.3(a), where in vitro diagnostic products are defined as "those
\[products\] intended for use in the diagnosis of disease or other
conditions, including a determination of the state of health, [in order
to cure, mitigate, treat or prevent disease or its
sequelae.]{.underline}" Therefore, if an item is not used to for a
medical purpose, it is not an in vitro reagent for FDA purposes, and it
cannot therefore be a "device" under the Statute. As documented above,
this has been FDA's own stated interpretation of 21 C.F.R. 809.3(a)'s
purpose and effect.

The Court of Appeals, however, found FDA's regulatory language to be
immaterial, and found the statutory language alone to be controlling,
writing, "\[t\]herefore, the Act regulates as a "device" an article
intended for use in diagnosis, regardless of whether medical treatment
will follow." 21 F.3rd at 1028. Such an interpretation would render the
21 C.F.R. 809.3(a) regulations meaningless. After determining that
"diagnosis" alone would suffice to create jurisdiction over a product
having no contact with the body, the court went on to employ a standard
dictionary definition of "diagnosis," thereby bringing within the FDCA
any "investigation or analysis of the cause of nature of a condition,
situation or problem." (21 F.3rd, at 1028). This definition would cover
the "investigation of analysis" of anything whatsoever: it is an
interpretation that is clearly beyond anything contemplated by Congress,
the FDCA or the historical implementation of the FDCA. Such a statutory
interpretation was far beyond what even FDA was seeking in the CRL case.
A statutory interpretation that is so expansive as to include "the
diagnosis of anything" is overbroad on its face; it demonstrates that
the appellate court's analysis in CRL is flawed, and that it does not
correctly interpret the FDCA, or its legislative intent.

The Tenth Circuit was also unconcerned with both (1) the test's use as a
screen (rather than an actual diagnosis), and (2) the test's explicit
business purpose, writing: "The fact that CRL's results were
inconclusive does not eliminate the diagnostic nature of CRL's
inquiry\.....Also, the fact that insurance companies rather than health
professionals considered CRL's findings to make business rather than
medical decisions does not erase the diagnostic character of CRL's
activities\...\....Therefore, we conclude that the specimen containers
at issue are devices within the meaning of 21 USC 321(h)(2) and subject
to FDA regulation." [Id]{.underline}. At 1028-1029.

In finding that no medical or therapeutic application is required for
FDA jurisdiction, the Court flatly contradicted FDA's own stated
premises and policies, a contradiction pointed out by Judge Cook in his
dissent from the majority opinion. Judge Cook noted that: "The
government concedes that it does not claim that a device which has no
medical application could 'qualify as a device under the FDCA,'" citing
FDA's own appellate brief. Justice Cook further noted that "\[t\]here is
no evidence present in the record that the containers involved here had
any medical application." [Id]{.underline}. At 1030.

At the district level, the district court in CRL based [its]{.underline}
holding on FDA's argument, that is, that there was some discernable
medical application to be found in the hypothetical outcome wherein an
applicant might somehow learn of the insurance company's test results
regarding HIV status. The appeals court, however, in finding that no
"medical" component of the "diagnosis" was required, created a new basis
for jurisdiction which even the FDA did not attempt to assert, and which
FDA, in fact, explicitly stated it did not have. It is perhaps worth
recalling that the congressional act creating the present-day 21 USC
321(h)(2) language regarding "devices" was called the 1976
[Medical]{.underline} Devices Act.

Even if one were to accept the CRL decisions as good law, and an
accurate interpretation of FDA jurisdiction, the "device" at issue in
CRL is significantly distinguishable from on-site drug test products,
and the CRL precedent should not attach to such products. The
similarities are that both are urine or saliva screens, used for
economic/business analysis (rather than for medical purposes). However,
CRL involved testing for HIV, while on-site kits test for drug use. This
distinction is sufficient to separate the OSDT from the tenuous
"medical-use" theory employed by the Court in CRL.

The principal distinction is this: The CRL test (for HIV) carried the
potential of providing to the test subject information regarding that
subject's condition [about which the test subject was not previously
aware]{.underline} (i.e., his HIV status). On the other hand, an on-site
drug test provides information (evidence of prior drug use) which is
newsworthy [only to the test administrator]{.underline}: the test
subject himself is of necessity already aware of the results of an
impending drug test, and cannot therefore possibly receive any new
information from the test. Therefore, the drug-test subject cannot make
any medical treatment decision as a result of the test itself (since he
is already aware of the outcome). Similarly, the drug-test subject
cannot directly benefit or suffer from the results: he is affected only
by the 3^rd^ party's receipt of the test results (and even then, the
affect is of a non-medical nature). This distinction eliminates the
speculative medical-use potential proffered by FDA in the CRL case.

The district court in CRL acknowledged that the CRL testing was done for
insurance (i.e., non-medical) purposes, but hung its decision of the
theory that the test subject could conceivably become aware of the
results (of either being HIV positive, or negative), and plan his future
behavior accordingly (791 F. Supp at 1507). If the test results were
inaccurate, the ramifications for the subject could be medically
harmful. Someone who learned of an HIV- negative result (when actually
positive) would fail to seek critical treatment, with tragic
consequences. Since the on-site drug test subject cannot learn anything
that he does not already know, the "medical-use" theory employed by FDA
in CRL cannot apply in the on-site drug test arena.

A further distinction is that the CRL articles involved testing for HIV,
clearly a "disease." On-site drug tests, however, test merely for drug
[use]{.underline}. Evidence of drug use does not mean that the subject
is ill, or is an addict. Drug testing reveals illegal and undesirable
activity, and does not entail illness, disease or addiction, or any
medical condition. Congress, in crafting the Americans with Disabilities
Act, explicitly stated "a test to determine the illegal use of drugs
shall not be considered a medical examination." 42 USC 12114(d)(1). The
courts have confirmed this approach, holding that drug tests do not
provide any basis for a medical evaluation of disability or illness.
[Copeland v. Philadelphia Police Dept.]{.underline}, supra; [McLeod v.
Detroit]{.underline}, supra. Indeed, FDA itself sought only to regulate
the CRL items in their capacity as HIV testing units, and not for their
other diagnostic uses (drugs, tobacco, etc.).

The appellate decision in CRL, because of its massively expansive
holding, does not lend itself to such distinctions. It would cover any
test of any kind. It expansiveness, however, is its undoing, since such
an interpretation is obviously not what Congress intended in creating
FDA jurisdiction.

### Other Laws Provide Consumer Protection 

There are laws administered by the Federal Trade Commission and other
federal and state agencies that provide adequate protection against
consumer fraud or abuse. SAMHSA is about to issue draft regulations
permitting the use of on-site tests for all federal employment drug
testing. CLIA may have some jurisdiction over testing, but HHS has
decided that Clinical Laboratory Improvement Act (CLIA) shall not apply
to workplace testing because HHS did not want to have a chilling effect
on such testing. See, 57 Fed Reg 7002 and \"Statement by Secretary Louis
W. Sullivan, M.D.\" HHS NEWS, U.S. Department of Health and Human
Services, August 28, l992, and see, \"Delay of Application of CLIA to
Workplace Drug Testing\", 58 Fed Reg 5220 (January 19, l993)

## Conclusion

The Supreme Court ([NLRB v. Bell Aerospace Co.]{.underline} 416 U.S. 267
(1974) has held that an agency is not free to reverse course on a
longstanding interpretation of its statute without adequate explanation.
This is precisely what FDA has done. Congress and FDA have created a
long-standing and consistent record regarding FDCA "device"
jurisdiction. The touchstone of "device" jurisdiction is that the
product must have some medical or therapeutic purpose or effect. This is
particularly true in the case of in vitro products, which are the
subject of explicit FDA regulatory language requiring
medical/therapeutic purpose. On-site test products have an exclusively
commercial purpose and therefore do not come within FDA jurisdiction.

Most significantly, burdensome regulation of on-site test products will
suppress the use of these products. The absence of, or decrease in such
drug testing will remove a proven suppressant of drug and alcohol use in
the workplace and elsewhere. The result will be a consequent increase in
the use of illicit drugs and alcohol, and with it, an increase in both
physical injury and economic harm across the spectrum. The
implementation of these regulations will ultimately result in widespread
harm to the public health, safety and welfare.

[^1]: ^?^There will be a preliminary issue of ripeness; as such a claim
    cannot be made until a "final agency decision" has been rendered.

[^2]: ^?^In vitro products do not contact the body. On-site drug tests
    are in vitro products.

[^3]: This case addressed whether a laboratory's specimen collection
    articles, used only in the health assessment of life insurance
    applicants, were medical devices. Life insurance companies requested
    this testing to assess underwriting risk and to validate the
    applicants' responses to lifestyle questions. The specimens were
    returned to the laboratory and tested for drug use, tobacco use, and
    other health assessment markers, including HIV. Consent forms
    explained that the tests were only for insurance assessment, and not
    for medical diagnosis. In case of a positive HIV result, further
    FDA-licensed testing was done to confirm. The results were not
    provided to the applicant. FDA brought its charge against the
    collection devices only in their capacity as HIV testing units, and
    not for their use in connection with the other assessments.