Should consumers be able to order genetic tests on their own, without a doctor’s involvement? Are the genetic tests being offered directly to consumers in increasing numbers reliable? Should these tests be more thoroughly regulated?
These issues will be considered Tuesday and Wednesday during a two-day meeting of an advisory committee to the Food and Drug Administration.
Generating the most attention are tests offered by companies like 23andMe that predict a person’s risk of getting various different diseases. Some tests predict responses to particular medicines or determine whether a person carries a mutation that might cause a disease like cystic fibrosis in his or her children.
Some critics say doctors or genetic counselors need to be involved. Critics also say some of the tests are scientifically faulty. But others accuse the medical establishment of turf-protecting paternalism. They say consumers have a right to information about their own DNA and can readily digest the information themselves.
The F.D.A. has already expressed concern about such tests. Last May, its objections stopped Pathway Genomics from selling a test through Walgreens drug stores.
The following month, the agency sent letters to five companies, including 23andMe, saying their tests were medical tests, not just consumer information, and therefore needed agency approval. But it did not take the tests off the market and it seems the F.D.A. is still figuring out what to do.
The agenda and other information for the meeting can be found here, and it also has been accepting written comments on the issue.
The genetic testing issue is only one event in a busy week for the F.D.A. Also on Tuesday, a separate advisory committee will consider the drug indacaterol, which is Novartis’s attempt to break into the lucrative market for inhaler-based drugs to treat chronic obstructive pulmonary disease.
Reuters provides an assessment of what’s at stake for the companies that now dominate that market: GlaxoSmithKline with its Advair, and Pfizer and Boehringer Ingelheim with Spiriva.
On Thursday, one F.D.A. advisory committee will look at possible neurological effects from the use of anesthesia in children and juvenile animals.
Another committee, meeting the same day, will consider issues related to epilepsy drugs, particularly Glaxo’s Lamictal XR.
The first new drug to treat lupus in half a century might win approval this week. Thursday is the deadline for the F.D.A. to decide whether to approve Benlysta, which was developed mainly by Human Genome Sciences and will be sold by that company and GlaxoSmithKline.
An advisory panel recommended approval of Benlysta by a 13-2 vote in November, despite concerns that the drug was only marginally effective. The disease, in which a person’s immune system attacks the body’s own tissues, affects mainly young women.
Other parts of Washington will be busy as well. On Friday one subcommittee of the House Appropriations Committee will be considering the proposed budget for the Department of Health and Human Services, with Secretary Kathleen Sebelius testifying. At the same time, in another room, a different subcommittee will be examining the F.D.A. budget, with Dr. Margaret A. Hamburg, an F.D.A. commissioner, testifying.
An insurance industry trade group, America’s Health Insurance Plans, will be holding its national policy forum Tuesday and Wednesday at the Ritz-Carleton Hotel in Washington. Later on Wednesday it will be co-sponsoring a separate meeting called the Health Care Cost Summit at the Westin Georgetown.
