Ex-FDA lawyer denies industry guided agency priorities

Former Food and Drug Adminstration Chief Counsel Sheldon Bradshaw has been put on the defensive regarding the agency's ties to industry following House Oversight and Government Reform Chairman Henry Waxman's assertion last week that FDA priorities highly favor the pharmaceutical industry.

"He's just simply wrong about his assertion," Bradshaw said.

At issue is a June 2007 request by Bradshaw that his assistant e-mail him a list of priority guidance documents and regulations that Bradshaw -- then at the agency -- could give a top Health and Human Services official to resubmit to FDA as his priority projects.

"All appear to prioritize industry desires over consumer protection," according to a letter Waxman, D-Calif., sent FDA Commissioner Andrew von Eschenbach last week. Waxman asked von Eschenbach to answer a series of questions by Oct. 6 to determine just how much precedence the list was given. Bradshaw questioned FDA's decision to even turn over the e-mail because as FDA's lawyer, his communications should be privileged.

FDA handed over the e-mail as part of an ongoing investigation, a spokeswoman for Waxman said. FDA declined to comment, and a spokeswoman said the agency would respond directly to Waxman's staff on the content of the letter.

Bradshaw declined to go into detail about his actions at the agency because he is limited in talking about former deliberations. He said the list was meant to help his office do its job representing the agency in court. "In putting together the list, I was advocating for the priorities and goals of the office of the chief counsel," he said. Bradshaw left FDA and joined Hunton & Williams in October 2007 as co-chairman of the law firm's food and drug group, where he represents drug companies.

Waxman singled out the first two priorities on the list that boost drug and device companies' legal defenses and relax FDA standards on promoting pharmaceuticals for uses not approved by the FDA, known as off-label use. While finalizing a guidance or rule at FDA typically takes years, Waxman noted "the first two items on the list appear to be moving in a matter of months."

FDA proposed the first priority, a regulation that helps protect the pharmaceutical and device industry from lawsuits, in January of this year and finalized it Aug. 15. Waxman wrote that the second priority, a guidance document on the use of medical journal articles to promote off-label use created in February, is on a fast track as well. Waxman and other Democrats raised concerns over both priorities as the documents moved through the agency's approval process.