A scathing report of the Food and Drug Administration concludes that the agency is woefully understaffed and underfunded and its technology is outdated.
The report comes in the wake of recent recalls of drugs, contaminated food and toxic toothpaste. It's getting to be that consumers aren't sure what products are safe anymore.
Unless something changes, the problems are going to get worse.
The report found that the FDA can't keep pace with the latest scientific advances. As a result: "American lives are at risk," the report said.
More troubling, many of the FDA's problems aren't new.
The same issues have plagued the agency for years. Yet, nothing seems to get done about it.
Three years ago, the FDA came under scrutiny after Merck withdrew its painkiller Vioxx after a study showed it increased risks of heart attack.
The agency was criticized for being too cozy with drugmakers. Critics said the FDA was focused on approving new drugs and not performing any follow-up to ensure their safety.
Last year, a report by the Institute of Medicine found the FDA was underfinanced and poorly managed. Many regulations were outdated. A report by the Government Accountability Office raised similar concerns.
The latest report by the FDA advisory panel of experts from academia, industry and other government agencies also highlighted many of the same issues.
To be sure, some of the FDA's problems have been thrust on the agency.
Congress has passed more than 100 laws expanding the FDA's authority since 1988. After the Sept. 11, 2001, terror attacks, the FDA was asked to beef up efforts to prevent bioterrorism.
Despite the added duties, the agency's budget has been basically flat for years. Staffing hasn't increased, and is in constant turnover. As a result, inspections are few and far between. Foodmakers, for example, get inspected about once a decade.
Granted, the FDA has a big job. It regulates the sale of more than $1 trillion of products annually, including food, drugs, cosmetics and medical devices. With the stakes so high, there's little margin for error.
But not all of the problems are due to a lack of funding. The FDA has a budget of more than $2 billion a year, and is seeking a 5.3 percent increase in the coming year.
U.S. Rep. Rosa DeLauro (D., Conn.), who chairs the subcommittee that oversees FDA funding, echoed what others have said over the years: "Money alone will not resolve the problems at FDA."
DeLauro said Congress will boost funding once the FDA implements a sound plan on how the funds will be used. She said the agency needs a better management structure.
People's health is at stake. Changes at the FDA are overdue.