Consumer-Directed Promotion of Regulated Medical Products; Public Hearing Docket No. 2005N-0354 Comments of Gail Javitt, JD, MPH, on behalf of the Genetics and Public Policy Center
Publication Date: November 2005
Author(s): Gail Javitt
Keywords: Genetic testing; Direct-to-consumer
Coverage: United States
Genetic testing is becoming an increasingly important part of health care. Genetic tests can help diagnose genetic conditions and guide treatment decisions, help predict risk of future disease, inform reproductive decision-making, and assist medication choices for a variety of diseases including some types of cancer. But while the number of tests available is exploding, genetic tests are subject to far less scrutiny than other medical products, and FDA oversight in particular has been very limited.