02/08/2007 - My name is Gail Javitt and I appreciate the opportunity to speak today on behalf of the Genetics and Public Policy Center at Johns Hopkins University. We would like to commend FDA for holding this public meeting.
The Genetics and Public Policy Center was founded in 2002 with a mission to help policy leaders, decision makers, and the public better understand and respond to the challenges and opportunities arising from advances in human genetics. In 2005, with funding from The Pew Charitable Trusts, the Center launched a Genetic Testing Quality Initiative with the goal of improving overall effectiveness, safety, and availability of genetic testing.
Today, there are more than 1000 genetic tests available clinically, and several hundred more available in research settings. These tests are used to diagnose disease, to predict risk of future disease, and -- more recently -- to guide decisions about whether to undergo a medical procedure or take a particular drug or dosage of a drug.
Yet the regulatory framework to ensure the safety and effectiveness of these tests is both incoherent and inadequate. Most genetic tests are not reviewed by any entity within the federal government before they are offered clinically. To date, FDA has cleared or approved only a handful of genetic test kits. Most genetic tests are sold as in-house developed tests (or “home brews”) and each laboratory director makes an independent decision regarding whether and when to make a test available.
Read the entire statement of Gail Javitt at the FDA public meeting on the agency’s draft guidance document addressing in vitro diagnostic multivariate index assays.
Pew is no longer active in this line of work, but for more information, visit the Genetics & Public Policy Center Web site or visit the Genetics and Public Policy Centeron PewHealth.org.