The fallout over California’s attempts to regulate genetic testing continued today as more facts over the California action came to light.
As the California Biotech Law Blog reported earlier this week , California’s Department of Health sent out cease and desist letters to thirteen genetic testing companies, including Navigenics, Inc. and 23andMe, Inc, demanding that these companies halt sales in the state until they can demonstrate that their laboratories are certified by the state and federal governments and that the tests have been ordered by a doctor as required by state law.
Wired.com is following the controversy, and has obtained copies of the letters that went out to at least two of the recipients. Alleging that the companies violated California law, the letters cite eight statutory provisions of California’s Business and Professions Code in support of their allegations: Sections 1206(a)(4), 1220(d), 1241, 1246.5, 1265(a)(1), 1281, 1287(b)(3), 1288.
These provisions state as follows:
- 1206(a)(4):"Clinical laboratory test or examination" means the detection,
identification, measurement, evaluation, correlation, monitoring,
and reporting of any particular analyte, entity, or substance within
a biological specimen for the purpose of obtaining scientific data
which may be used as an aid to ascertain the presence, progress, and
source of a disease or physiological condition in a human being, or
used as an aid in the prevention, prognosis, monitoring, or treatment
of a physiological or pathological condition in a human being, or
for the performance of nondiagnostic tests for assessing the health
of an individual.
- 1220(d) (1) Each clinical laboratory shall perform all clinical
laboratory tests or examinations classified as waived under CLIA in
conformity with the manufacturer’s instructions.
(2) Except for those clinical laboratories performing only tests
or examinations classified as waived under CLIA, each clinical
laboratory shall establish and maintain all of the following:
(A) A patient test management system that meets the standards of
CLIA in Subpart J (commencing with Section 493.1101) of Title 42 of
the Code of Federal Regulations.
(B) A quality control program that meets the requirements of CLIA
in Subpart K (commencing with Section 493.1201) of Title 42 of the
Code of Federal Regulations.
(C) A comprehensive quality assurance program that meets the
standards of CLIA in Subpart P (commencing with Section 493.1701) of
Title 42 of the Code of Federal Regulations.
- 1241: This chapter applies to all clinical laboratories in
California or receiving biological specimens originating in
California for the purpose of performing a clinical laboratory test
or examination, and to all persons performing clinical laboratory
tests or examinations or engaging in clinical laboratory practice in
California or on biological specimens originating in California,
except as provided in subdivision (b).
(b) This chapter shall not apply to any of the following clinical
laboratories, or to persons performing clinical laboratory tests or
examinations in any of the following clinical laboratories:
(1) Those owned and operated by the United States of America, or
any department, agency, or official thereof acting in his or her
official capacity to the extent that the Secretary of the federal
Department of Health and Human Services has modified the application
of CLIA requirements to those laboratories.
(2) Public health laboratories, as defined in Section 1206.
(3) Those that perform clinical laboratory tests or examinations
for forensic purposes only.
(4) Those that perform clinical laboratory tests or examinations
for research and teaching purposes only and do not report or use
patient-specific results for the diagnosis, prevention, or treatment
of any disease or impairment of, or for the assessment of the health
of, an individual.
(5) Those that perform clinical laboratory tests or examinations
certified by the National Institutes on Drug Abuse only for those
certified tests or examinations. However, all other clinical
laboratory tests or examinations conducted by the laboratory are
subject to this chapter.
(6) Those that register with the State Department of Health
Services pursuant to subdivision (c) to perform blood glucose testing
for the purposes of monitoring a minor child diagnosed with diabetes
if the person performing the test has been entrusted with the care
and control of the child by the child’s parent or legal guardian and
provided that all of the following occur:
(A) The blood glucose monitoring test is performed with a blood
glucose monitoring instrument that has been approved by the federal
Food and Drug Administration for sale over the counter to the public
without a prescription.
(B) The person has been provided written instructions by the child’
s health care provider or an agent of the child’s health care
provider in accordance with the manufacturer’s instructions on the
proper use of the monitoring instrument and the handling of any
lancets, test strips, cotton balls, or other items used during the
process of conducting a blood glucose test.
(C) The person, receiving written authorization from the minor’s
parent or legal guardian, complies with written instructions from the
child’s health care provider, or an agent of the child’s health care
provider, regarding the performance of the test and the operation of
the blood glucose monitoring instrument, including how to determine
if the results are within the normal or therapeutic range for the
child, and any restriction on activities or diet that may be
(D) The person complies with specific written instructions from
the child’s health care provider or an agent of the child’s health
care provider regarding the identification of symptoms of
hypoglycemia or hyperglycemia, and actions to be taken when results
are not within the normal or therapeutic range for the child. The
instructions shall also contain the telephone number of the child’s
health care provider and the telephone number of the child’s parent
or legal guardian.
(E) The person records the results of the blood glucose tests and
provides them to the child’s parent or legal guardian on a daily
(F) The person complies with universal precautions when performing
the testing and posts a list of the universal precautions in a
prominent place within the proximity where the test is conducted.
(7) Those individuals who perform clinical laboratory tests or
examinations, approved by the federal Food and Drug Administration
for sale to the public without a prescription in the form of an
over-the-counter test kit, on their own bodies or on their minor
children or legal wards.
(8) Those certified emergency medical technicians and licensed
paramedics providing basic life support services or advanced life
support services as defined in Section 1797.52 of the Health and
Safety Code who perform only blood glucose tests that are classified
as waived clinical laboratory tests under CLIA, if the provider of
those services obtains a valid certificate of waiver and complies
with all other requirements for the performance of waived clinical
laboratory tests under applicable federal regulations.
(c) Any place where blood glucose testing is performed pursuant to
paragraph (6) of subdivision (b) shall register by notifying the
State Department of Health Services in writing no later than 30 days
after testing has commenced. Registrants pursuant to this
subdivision shall not be required to pay any registration or renewal
fees nor shall they be subject to routine inspection by the State
Department of Health Services.
- 1246.5: Notwithstanding any other provision of law, any person may
request, and any licensed clinical laboratory or public health
laboratory may perform, the laboratory tests specified in this
section. A registered clinical laboratory may perform the laboratory
tests specified in this section if the test is subject to a
certificate of waiver under CLIA and the laboratory has registered
with the department under paragraph (2) of subdivision (a) of Section
1265. A program for nondiagnostic general health assessment that
includes a laboratory test specified in this section shall comply
with the provisions of Section 1244. The results from any test may
be provided directly to the person requesting the test if the test is
on or for his or her own body. These test results shall be provided
in a manner that presents clear information and that identifies
results indicating the need for referral to a physician and surgeon.
The tests that may be conducted pursuant to this section are:
pregnancy, glucose level, cholesterol, occult blood, and any other
test for which there is a test for a particular analyte approved by
the federal Food and Drug Administration for sale to the public
without a prescription in the form of an over-the-counter test kit.
A test approved only as an over-the-counter collection device may not
be conducted pursuant to this section.
- 1265(a)(1):A clinical laboratory performing clinical laboratory
tests or examinations classified as of moderate or of high complexity
under CLIA shall obtain a clinical laboratory license pursuant to
this chapter. The department shall issue a clinical laboratory
license to any person who has applied for the license on forms
provided by the department and who is found to be in compliance with
this chapter and the regulations pertaining thereto. No clinical
laboratory license shall be issued by the department unless the
clinical laboratory and its personnel meet the CLIA requirements for
laboratories performing tests or examinations classified as of
moderate or high complexity, or both.
- 1281:It is unlawful for any person to own, operate, maintain,
direct, or engage in the business of operating a clinical laboratory,
as defined in this chapter, unless he or she possesses a valid
clinical laboratory license issued by the department. In the event a
health facility does not perform clinical laboratory services, but
provides laboratory services to its patients under an agreement with
another person or entity that holds and is operating under a valid
clinical laboratory license, the health facility shall not be
required to obtain a clinical laboratory license.
- 1287(b)(3): The enforcement remedies provided under this section are not
exclusive, and shall not preclude the use of any other criminal or
civil remedy. However, an act or omission punishable in different
ways by this section and any other provision of law shall not be
punished under more than one provision. Under those circumstances,
the penalty to be imposed shall be determined as set forth in Section
654 of the Penal Code.
- 1288:Any person conducting or operating a clinical laboratory may
accept assignments for tests only from and make reports only to
persons licensed under the provisions of law relating to the healing
arts or their representatives. This section does not prohibit the
acceptance of evaluation specimens for proficiency testing or
referral of specimens or such assignment from one clinical laboratory
to another clinical laboratory, either licensed or exempt under this
chapter, providing the report indicates clearly the laboratory
performing the test. A report of results issuing from a clinical
laboratory shall show clearly the name and address of the laboratory
and the name of the director.
The letters demand that the party submit a plan before June 23, 2008 advising how the company will prevent further violation of the law.
It is impossible to determine from these letters whether or not these companies actually are in violation of the law; however, assuming the allegations are in fact accurate, is this really the whole story? Or is something else actually responsible for this "attack" on genetic testing companies? What is prompting this interest in genetic testing?
I cannot help but wonder if the medical community is at the heart of this controversy. But if this is in fact the case, what is the issue? Is there a concern by doctors that they are going to be found guilty of malpractice simply as a result of something they either overlook or do not know how to respond to in the genetic testing report? As we suggested in our previous blog posting, there is certainly some debate as to how accurate various genetic tests actually are and what, if anything, should be done in response to certain results. On the other hand, is there a fear by the medical community that the public will not know how to handle the data in the report? Or is there at the heart of this issue an entirely different matter entirely?
It is interestng that in the same week that this controversy has erupted, Newsweek ran a story about Dean Ornish’s new book, where he looks at how changing lifestyle can change genes. The prospect of potentially changing your genetic predisposition by making lifestyle changes is perhaps the best argument for why the public should have direct access to these tests. Thomas Goetz of Wired.com also makes a compelling argument for direct access, arguing that "Frankly, it’s insulting and a curtailment of my rights to put a gatekeeper between me and my DNA."
To date, this controversy has erupted in only two states: New York and California. There are forty-eight other states yet to take this issue up. Those states will be looking to New York and California to see how they deal with the controversy. Perhaps the California legislature should jump to the forefront of this issue and look at changing the law to ensure direct public access to genetic testing. Such an action would undoubtedly set an important precedent for the other forty-nine states, which might very well follow in California’s footsteps. California: will you rise to the challenge?
The California Biotech Law Blog will continue following this controversy as it further unfolds.
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