Genetics + Public Policy Center calls for stronger federal regulation of genetic

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Genetics and Public Policy Center calls for stronger federal

regulation of genetic testing, USA

http://www.medicalnewstoday.com/medicalnews.php?newsid=34344

The Genetics and Public Policy Center this week called on Mark

McClellan, Administrator of the Centers for Medicare and Medicaid

Services (CMS), to end years of delay in assuring the safety and

accuracy of genetic testing by issuing a proposed rule to create a

genetic testing specialty under the Clinical Laboratory Improvement

Amendments (CLIA) of 1988. The delay has meant that scientific and

technological advances in genetic testing have outpaced the

government's ability to provide adequate oversight, maintains the

Center, which was established by The Pew Charitable Trusts through

s Hopkins University.

CMS, an agency of the U.S. Department of Health and Human Services,

administers standards for diagnostic laboratory testing, such as

those used for blood sugar, urinalysis, or HIV infection, to ensure

that the tests are accurate and reliable and that physical conditions

at the laboratories meet certain expectations.

" For more than ten years, federal advisory committees have been

calling upon the government to provide more oversight of genetic

tests, " the letter to McClellan from the Center notes. CMS responded

to the growing sense of urgency to improve genetic testing oversight

five years ago by issuing a Notice of Intent of proposed rulemaking

that incorporated recommendations from a federal advisory group

regarding development of a genetic testing specialty.

" More than five years later, nothing has been issued by (CMS), " the

letter says. During the same period, the genetic testing industry has

grown dramatically; today, more than 800 genetics tests are available

clinically, and many more are in development. " These genetic tests

may be the basis for profound life decisions, such as whether to

undergo prophylactic mastectomy, terminate a pregnancy, or take a

certain drug or certain dosage of a drug, " according to the letter.

Under CLIA, CMS is charged with developing standards for how medical

laboratory tests are conducted, the training and proficiency of

laboratory personnel, and other standards to ensure the quality of

clinical tests. The problem, says Center policy analyst Gail Javitt,

an author of the letter, is that CLIA did not include a genetic

testing specialty for the then-nascent field of genetic testing as

part of its oversight regime.

" The absence of a specialty area for genetic testing with

specifically tailored requirements for the now-burgeoning genetic

testing industry hampers CLIA's ability to oversee the quality of

genetic testing and adequately to ensure its safety, " she writes. " We

urge CMS to take immediate steps to issue proposed regulations for a

genetic testing specialty. "

The Center reviewed all the comments that were collected by CMS five

years ago in response to the Notice of Intent, Javitt

explains. " There were no showstoppers here in terms of issues central

to the regulation, " she says. " Rather, we found substantial support

for the creation of a genetic testing specialty. " There were specific

concerns about a few of the proposed requirements detailed in the

Notice of Intent, she explained, but these that could be left out of

the final rule without unduly weakening the regulation. " A genetic

testing specialty is achievable if it focuses on key quality

requirements such as analytic and clinical validity of the tests and

proficiency standards for laboratory personnel, " she added.

" The government has been dragging its feet for more than 10 years

about improving the quality of genetic testing, " she said. " It's time

to move swiftly to protect the American public and publish a proposed

rule. "

Genetics & Public Policy Center, s Hopkins University

http://www.dnapolicy.org