The House Energy and Commerce Committee's Health Subcommittee tomorrow will consider Food and Drug Administration (FDA) legislation that would help ensure the public is protected from unsafe drugs, but the proposal needs more safeguards to protect federal scientists, according to the Union of Concerned Scientists (UCS). The hearing is scheduled for 10 am in 2123 Rayburn House Office Building.

"The legislation does not get to the heart of the problem," said Dr. Francesca Grifo, director of UCS's Scientific Integrity Program. "FDA scientists, charged with evaluating drugs, are often ignored and their work suppressed."

UCS has called for provisions guaranteeing an open drug approval process, which is accessible to the public and that includes FDA scientists' dissenting views. FDA scientists must have the freedom to publish their research and to express dissenting views within the agency.

"When FDA scientists find that the agency is compromising our health and safety, they should have the right to freely report these problems, without fear of retaliation or being marginalized," Grifo said.

The popular diabetes drug Avandia, the antibiotic Ketek, and serotonin reuptake inhibitors (SSRIs) – a family of antidepressants – are drugs that the FDA initially approved that had serious negative side effects. In each case, the FDA failed to heed the warnings of its own scientists.

In 2006, UCS and Public Employees for Environmental Responsibility (PEER) conducted a survey of nearly 1,000 FDA scientists. Their responses painted a disturbing picture of an agency in which regulatory deadlines and industry pressure has undermined the quality of science, posing a potential threat to public health. Nearly two in three respondents (617 scientists) said that the "laws and regulations that govern FDA, including the agency's structure, need to be changed for the agency to better serve the public."  (http://www.ucsusa.org/scientific_integrity/interference/fda-scientists-survey-summary.html)