Healthy Skepticism Library item: 14324
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Heavey S.
U.S. lawmaker questions FDA, cites industry ties
Reuters Health 2008 Sep 17
http://www.reuters.com/article/healthNews/idUSN1750422220080918
Full text:
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 FDA 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.
“All appear to prioritize industry desires over consumer protection,” Waxman wrote. The initiatives also appear to have bypassed normal regulatory channels so they could be implemented sooner.
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 after it was linked to 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.
In Waxman’s letter, he said a June 15, 2007 e-mail from then FDA Chief Counsel Sheldon Bradshaw showed Bradshaw planned to forward a list of agency priorities to the deputy secretary at the U.S. Department of Health and Human Services.
“I’ll send that list to the Deputy Secretary who, in turn, will send it back to the FDA as his list of priority projects. That will ensure that our projects are moved in a timely fashion,” Bradshaw said in one e-mail, according to Waxman.
Bradshaw, a lawyer who now represents the food and drug industry in private practice, said the agency’s priorities focused on public health, even if some also were supported by drugmakers.
“It’s simply incorrect to assume that an FDA initiative can’t be for the promotion of the public health if the industry supports it,” he told Reuters.
“Industry had absolutely nothing to with the list,” he added.
In his letter, Waxman said Bradshaw and the deputy secretary, Tevi Troy, have ties to the pharmaceutical industry.
Before joining HHS, Troy worked for two think tanks with drug company ties, the letter said, adding that Troy’s brother works as a lawyer for GlaxoSmithKline Plc.
But Bradshaw said he never represented an FDA-regulated company prior to joining the agency. Troy was sworn in his position at HHS in August 2007, two months after Bradshaw’s e-mail.
FDA spokeswoman Heidi Rebello said the agency would review Waxman’s letter and respond to the congressman.
She added that agency has an ambitious agenda that also includes tackling inspection reform and other safety issues.
“It would be a mistake to think that the thousands of dedicated employees working on FDA issues cannot pursue a wide range of public health priorities concurrently,” she said.
HHS representatives had no comment on Troy and referred requests for comment to the FDA.
