**PUBLIC COMMENTS SUBMITTED BY:**

**[GENETIC ALLIANCE]{.underline}**

**BEFORE THE**

**FOOD AND DRUG ADMINISTRATION**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**"[DIRECT-TO-CONSUMER MARKETING OF GENETIC TESTS]{.underline}"**

**November 2, 2005**

Genetic Alliance---an international coalition comprised of more than 600
advocacy, research, and health care organizations that represent over 14
million individuals with genetic conditions and their
interests---appreciates the opportunity to comment on this important
issue.

As you examine the issues surrounding direct-to-consumer promotion of
regulated medical products, it is vital that you consider the
perspectives of all of the different stakeholders---including consumers.
Genetic Alliance and our members represent individuals with genetic
conditions, many of them rare genetic conditions; thus, our concerns
related to direct-to-consumer marketing focus primarily on genetic
tests.

Specifically, two related, but distinctly different, areas of concern
are:

**• The current state of regulatory oversight of genetic tests. Are the
tests safe and accurate? Are there gaps in the regulatory process?**

**• The potential for irresponsible or misleading promotion of genetic
tests. Do the tests do what the advertisements say they do? Do consumers
have enough information to make informed decisions about tests?**

The Genetic Alliance community is concerned, not only with the safety
and accuracy of genetic tests, but also the accessibility of those
tests. As such, our organization is careful to consider the impact on
access when advocating for increased regulation of any kind. However,
the current state of genetic test regulation is such that additional
oversight is quite clearly a necessity. **At present, the oversight
mechanisms associated with genetic tests have significant gaps; thus,
direct-to-consumer marketing of these tests poses a serious threat**.
More specifically, the marketing of a genetic test actually presents two
discrete areas for concern: the claims made in an advertisement, and the
validity and utility of the test being marketed and sold to consumers.

Currently, there are more than 1000 genetic tests available; but, only a
handful---packaged as test kits---are regulated by the Food and Drug
Administration. As a result, the vast majority of genetic tests
available are essentially unregulated, with only the Clinical Laboratory
Improvement Amendments of 1988 to ensure their safety and accuracy.
Under CLIA, laboratories are held to certain standards, standards based
on the complexity of the test performed. In this, the Genomic Age, more
rigorous regulation, performed by either the FDA or via CLIA, or some
complement of both, is necessary. However, to ensure that nothing falls
through the cracks, a coordinated effort across agencies would be ideal.

That said, an onerous system of regulation for genetic tests, one that
discourages testing, is also unacceptable. Just as important to our
organization and its members as safety and accuracy is the
*accessibility* of genetic tests. Overzealous regulation---and its
implications---would likely make genetic tests, specifically those for
rare genetic conditions, inaccessible to most individuals and their
families. This is an equally problematic outcome, one that must not be
ignored or underestimated. The safety and accuracy of testing is
essentially irrelevant if the tests are not accessible to the
individuals who need them most.

**Once genetic tests have received the regulatory attention they
require, direct-to-consumer marketing of those tests, when delivered
with the appropriate information and support services, could be
acceptable for some tests**. As science continues to move forward, and
as more and more genetic tests become available, access to these tests
may be the key to improved health outcomes. However, it is irresponsible
to offer genetic tests with no validation, context, or explanation to
the public. Quite often, genetic tests offer predictive information and
information about the current and future health of individuals *and*
their families. Like many other medical tests and procedures, this
information can be confusing and intimidating if it is not appropriately
translated by a health care professional. As such, genetic tests offered
directly to consumers should include opportunities for genetic
counseling, opportunities that would provide an individual with all the
information needed to make the most appropriate decisions about his own
health care and the health care of his family.

On behalf of Genetic Alliance, I urge this panel to address both of the
aforementioned concerns: concerns about the adequacy of genetic testing
oversight, and concerns regarding the potential for irresponsible
direct-to-consumer marketing and sale of those tests. Genetic tests
should be accessible to consumers in a form that is safe, reliable, and
accurate. However, they must also be accessible. We must find a balance
between regulation that accomplishes the desired goals---quality genetic
tests that improve public health---and excessive regulation that places
too onerous a burden on laboratories and limits the availability of
tests.

Genetic Alliance has made genetic testing quality a priority for the
upcoming year. We will be working with patient groups, industry members,
policy organizations, and government officials to craft sensible
solutions that ensure access to quality genetic tests. We look forward
to working with you.

**[Sharon F. Terry]{.underline}**

**President and CEO**

**Genetic Alliance**

**4301 Connecticut Avenue, NW**

**Suite 404**

**Washington, DC 20008**

**Telephone: 202.966.5557 ext. 213**

**Fax: 202.966.8553**