Editor's Notes:

This year marks the hundred–year anniversary of the FDA, an opportune time to reflect on the challenges the agency has faced in the past and how it is weathering current controversies. In this article, six former senior FDA staffers talk candidly about the "agency's mission going forward, its leadership, drug safety, Plan B and the Critical Path Initiative." A must read for anyone interested in how the agency balances safety and efficacy concerns—along with Washington, D.C. politics.

On June 30, 1906, President Theodore Roosevelt signed into law the Federal Food & Drug Act that established the Division of Chemistry in the US Department of Agriculture. In 1927 the division's name was changed to the Food, Drug & Insecticide Administration, which in turn became the Food & Drug Administration in 1930. Though having shed insecticides, the FDA at 100 still regulates fully one–fourth of the US economy, and everyone working in the healthcare field daily feels its impact on his or her work. To assess the FDA's current status and reputation, we turned to some of those in the best position to make an objective judgment: FDA alumni who only recently held high positions in the agency but who, having left, can speak openly and frankly.

Editor's Notes:

The U.S. government is using a relatively big carrot—$1 billion in new funding—to encourage five pharmaceutical companies to increase vaccine manufacturing capacity in the U.S. using cutting edge technology. The investment is being driven by concerns over a potential avian flu pandemic, but it also is an initiative designed to reverse decades of atrophy in U.S.–based vaccine manufacturing.

The federal government yesterday awarded $1 billion in contracts to five pharmaceutical companies to help them develop modern methods of producing influenza vaccine that would replace the current slow, laborious and unpredictable technique.

The awards mark a huge step forward in the Bush administration's $7.1 billion effort to plan for an influenza pandemic, which many experts believe is likely in the next decade. "The capacity simply does not exist in the United States to produce vaccine of sufficient quantity to vaccinate everybody. But that's about to change," Michael O. Leavitt, secretary of health and human services, said at a signing ceremony...

The companies each agreed to build or expand a vaccine plant in this country. Each will seek to grow flu vaccine virus in cell cultures rather than in fertilized chicken eggs and apply for Food and Drug Administration approval for its vaccine. Each company is also investing large amounts of its own money—some have done so already—although few executives yesterday were willing to say how much.

In five years, if all goes as planned, the companies together should be able to make about 300 million doses of vaccine in six months—enough to immunize every U.S. resident.

This is certainly a good start, but additional work needs to be done to insulate vaccine manufacturers from legal liability and streamline how vaccines are regulated and approved by the FDA.