FDA regulation no panacea

Filed in archive Regulation on May 19, 2006

As reported in my last post, several environmental groups have teamed up to ask the Food and Drug Administration (FDA) to recall sunscreens and further regulate their use. Let's look at what might happen if they're successful.

Brian Alexander, author of Rapture: How Biotech Became the New Religion, wrote a lengthy article in glamour magazine citing growing concerns among doctors and scientists about the declining quality and increasing politicization of FDA regulation:

"As a physician, I can no longer trust government sources," says Ruth Shaber, M.D., Kaiser Permanente's director of women's health services for northern California and head of the HMO's Women's Health Research Institute. "I no longer trust FDA decisions or materials generated [by the government]. Ten years ago, I would not have had to scrutinize government information. Now I don't feel comfortable giving it to my patients."

Susan F. Wood, Ph.D., then the head of the FDA's Office of Women's Health, found the administration's 2003 decision to deny over-the-counter availability of the so-called "morning after" birth control pill suspect. "This decision was not based on science and clinical evidence. This threatens the FDA's credibility, and it threatens the faith the public has in the FDA for making sure products are safe and effective."

The New England Journal of Medicine, the nation's leading medical journal, agreed, running an editorial titled "A Sad Day for Science at the FDA." The decision, it said, "appeared to reflect political meddling in the drug-approval process."

Wood said that morale at the FDA has sunk to a new low because of overwhelming pressure from social conservatives.

Those excerpts and many more examples from Alexander's article raise many concerns. And if you think political ideologies and agendas won't influence nanotech decisions, just look at stem cell research.

Let's not hold FDA regulation out as a panacea for nanotech safety, because it will never be that. Rather than count on the government to always put public safety before political ideology (unlikely), let's build an informed public capable of recognizing biases and weighing diverse views. (photo L'Oreal)