food and drug administration,
Gerald Herbert/AP
Tom Daschle

FDA Employees Say Agency Isn’t Working Properly

January 12, 2009 03:03 PM
by Lindsey Chapman
Nine Food and Drug Administration scientists have written a letter to President-elect Barack Obama asking him to fix the “broken” organization.

Letter to President-elect Obama

A slew of problems at the Food and Drug Administration are “placing the American people at risk,” the FDA scientists explained to President-elect Obama. 

CNN obtained a copy of the letter, which states that dishonesty is prevalent at the agency, and that the scientific review process used to ensure the safety of medical devices is insufficient. In fact, the authors of the letter say scientists and doctors have periodically been told to ignore FDA regulations.

The group also charged that some products are allowed on the market without FDA approval, some are improperly labeled and that even though there was an internal investigation into the accusations, “absolutely nothing” came of it.
Funding may be a part of the problems currently felt at the FDA. According to The New York Times, the Agriculture Department is responsible for inspecting meat and poultry, which comprises approximately 20 percent of the country’s food supply, while the FDA takes charge of nearly everything else. However, more federal funding is directed toward the Agriculture Department.

Meanwhile, a fair portion of the money the FDA does receive is directed toward drug safety. “With a limited budget and a huge workload, the food side of the agency has lurched from one crisis to the next,” The New York Times explained.

The solution? Some people have suggested procedural changes at the FDA, such as replacing voluntary food safety guidelines with definitive rules. Others say it’s time to make one food safety agency.

“The most ideal thing is, they should have a single food agency,” Michael Hansen, a scientist at Consumers Union told The New York Times. “Who knows? Times change. If you would have said six or eight years ago that Bush would almost nationalize part of the banking industry, people would have told you you were crazy.”

Consequences of the Letter

Tom Daschle, who was recently chosen by Obama to lead the Department of Health and Human Services, will likely feel additional pressure to make changes at the FDA, according to The Wall Street Journal. Both houses of Congress have accused the agency of “being too close to industry.”

“I want to reinstate a science-driven environment,” Daschle said in a Reuters article. “I want to take ideology and politics as much as humanly possible out of the process and leave the scientists to do their job.”

Key Player: The FDA

The “modern era of the FDA” began in 1906 when the Federal Food and Drugs Act was passed. The agency is a scientific and regulatory body responsible for helping protect public health. According to the FDA’s Web site, the organization regulates many food products, drugs, medical devices and more. These items represent “25 cents of every dollar spent by consumers.”

As part of the transition to President-elect Barack Obama’s administration, the leadership of the FDA and the Centers for Disease Control and Prevention (CDC) will change. It is “a matter of practice,” according to The Washington Times, for an incoming president to ask the outgoing administration to obtain resignation letters from its political appointees. Frank Torti, who is currently the principal deputy commissioner and chief scientist at the FDA, will replace the agency’s current leader, Dr. Andrew von Eschenbach.

Related Topics: Controversial FDA decisions

In addition to recent food scares, other controversial drug-related decisions have placed the FDA into the national spotlight.

Gardasil Vaccine

After reviewing thousands of reports of health problems reportedly linked to the HPV vaccine Gardasil, U.S. officials said that “its benefits continue to outweigh its risks.” The FDA and the CDC jointly reviewed more than 9,700 cases of health problems that followed Gardasil injections, including death. “There was not a common pattern to the deaths that would suggest they were caused by the vaccine,” the agencies said in a statement.


In 2008, the federal government was encouraging doctors to recommend the Pfizer drug Chantix to patients who want to quit smoking, despite side effects that can include depression and suicide. In November 2007, the FDA began investigating Chantix after it “received reports of mood disorders and erratic behavior” among patients of the drug.


In September 2008, a new study released by the American Medical Association suggested that adults exposed to high levels of bisphenol A (BPA) were more likely to report having heart disease and diabetes. These particular findings about the chemical were new, even though it had a longer history of concerns.

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