The U.S. Food and Drug Administration, or FDA, convened a public meeting today, and will do so again tomorrow, July 20, 2010 to discuss how to oversee laboratory developed tests. The goal of FDA regulation is “to find the right approach to maximize public health and minimize the risk.” To view today’s webcast or to join in tomorrow’s, go to the FDA website by clicking here.
To read today’s live transcript, click here. Note that many people of varied backgrounds spoke today. This included representatives of advocacy groups, the president of the National Society of Genetic Counselors, and CEOs/directors of a number of personalized medicine and laboratory companies, among others.
If you plan to join tomorrow, get onto the webcast at your earliest convenience as the meetings ended 90 minutes early today and are expected to end even earlier tomorrow.
Additionally this week, on Thursday, July 22, 2010, the Subcommittee on Oversight and Investigations of the House of Representatives Committee on Energy and Commerce will hold its “Hearing On Direct-To-Consumer Genetic Testing And The Consequences To The Public Health”.
The hearing begins 9:30 a.m. (Eastern) EDT. While this is not a public meeting, consumer comments will be accepted by representatives. Note to send these comments by FAX, as letters get help up in security screening. Thus, if you have a direct-to-consumer testing experience or an otherwise informed opinion that should be heard by the Congressional members, contact by fax:
• Rep. Henry Waxman, Chairman of the House Committee on Energy and Commerce, 202-225-4099
• Rep. Joe Barton, Ranking Member, House Committee on Energy and Commerce, 202-225-3052
• Rep. Bart Stupak, Chairman, Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, 202-225-4744
• Rep. Michael C. Burgess, Ranking Member, Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, 202-225-2919
• Rep. Frank Pallone Jr., Chairman, Subcommittee on Health of the House Committee on Energy and Commerce, 202-225-9665
• Rep. John Shimkus, Ranking Member, Subcommittee on Health of the House Committee on Energy and Commerce, 202-225-5880
If you are new to this controversy, in short a number of laboratories and personalized medicine companies offer genetic testing to consumers directly with no regulation and with no health care provider involved. Test kits are ordered from the internet by a consumer, mailed directly to the ordering consumer who reads the instructions to collect and send in a swab of the inside of their cheek, and genetic testing is conducted on the cheek cells. The results are available to the consumer generally by accessing a website. Tests run are numerous and include tests that predict risk for many different diseases, including various cancers and Alzheimer’s, and define drug dosages. While the tests are commercially available, that does not mean the tests should be conducted. A number of the tests have little clinical meaning, some have little data to support their use, and some consumers have gotten wrong results.
So the current questions are around regulating this area of tests in a manner that protects the consumer without limiting access to the technology. While nothing will be finalized this week, consumers and healthcare providers need to take part now. This is the time to be heard.