WASHINGTON (Reuters) – The U.S. Food and Drug Administration appears to be giving priority to projects that benefit the pharmaceutical industry rather than helping consumers, a top Democratic lawmaker said on Wednesday.
The head of the U.S. House of Representatives Oversight and Government Reform Committee questioned how the FDA set its priorities given recent controversies over its handling of safety issues, including tracking tainted foods and inspecting drug manufacturers.
A 2007 list of top projects includes plans to offer advice to companies on promoting products, as well as guidance on offering reprints of journal articles to physicians, California Democrat Henry Waxman said in a letter to FDA Commissioner Andrew von Eschenbach.
The agency also planned to change its regulations to protect device makers from lawsuits as long as their products are FDA-approved with a so-called preemption clause.
“All appear to prioritize industry desires over consumer protection,” Waxman wrote.
The FDA has come under fire in recent years following a string of highly-publicized safety scares, starting with the 2004 withdrawal of Merck & Co Inc’s painkiller Vioxx following heart problems.
The risk of suicide with antidepressants and other drugs, as well as tainted batches of blood-thinner heparin and bacteria-laced produce such as spinach and hot peppers have also fueled concerns.
Asked if it had any response, FDA spokeswoman Heidi Rebello said the agency would comment directly to Waxman.
In his letter, Waxman said a June 15, 2007 e-mail from then FDA Chief Counsel Sheldon Bradshaw showed he planned to forward a list of agency priorities to Deputy Secretary of Health and Human Services Tevi Troy. Both have ties to the pharmaceutical industry.
The initiatives also appear to have bypassed normal regulatory channels so they could be implemented sooner, Waxman said.
Before joining HHS, Troy worked for two think tanks with drug company ties, Waxman said, adding that Troy’s brother works as a lawyer for GlaxoSmithKline Plc.
Bradshaw, a lawyer who now represents the food and drug industry in private practice, and representatives for the Department of Health and Human Services either could not be immediately reached or had no immediate comment.