Federal Daily - October 31, 2008

Study Shows FDA Career Staffers Were Overruled on Lawsuit Policy

Senior Food and Drug Administration (FDA) staffers opposed a proposed 2006 agency rule that weakened consumers’ ability to sue pharmaceutical companies, according to a congressional report posted Oct. 29 on the Internet. The rule, which the agency eventually adopted, limits when people can sue in state court over injury claims involving FDA-approved medications, said the report released by Rep. Henry Waxman, D-Calif., chairman of the House Oversight and Government Reform Committee. Such state court claims are barred under the rule, which contends federal regulations—in this case those issued by the FDA—prevail when there is a conflict with state law. This concept, called preemption, was opposed by career FDA officials and top agency scientists who claimed it was based on a “false assumption” that FDA-approved labeling is accurate and up-to-date. “Historically, the Food and Drug Administration has viewed lawsuits brought by persons injured by a drug as a valuable complement to the agency’s regulatory efforts,” the report said. “The longstanding view of the agency has been that private litigation can provide an additional layer of protection against unsafe drugs.” The 2006 policy turns that approach upside down, said Brian Wolfman, litigation director for Public Citizen, a government watchdog group. “The documents reveal that top FDA officials who deal with drug safety on a day-to-day basis do not believe that lawsuits undermine consumer safety,” Wolfman said, “but their views were overridden by political appointees who lacked any empirical support for their views.” To see more, go to: http://oversight.house.gov/story.asp?ID=2266 or www.publiccitizen.org/pressroom/release.cfm?ID=2757.

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Senators Question New VA Health Care Plan

Sens. Daniel Akaka, D-Hawaii, and Jay Rockefeller, D-W.V., have questioned the viability of a new Department of Veterans Affairs (VA) plan that emphasizes leasing facilities or purchasing care from outside providers, while downsizing efforts to construct new VA facilities. Akaka and Rockefeller, the Senate Veterans Affairs Committee chairman and former chairman, respectively, inquired about the implications that such a plan would have on the VA health care system—including the number of current VA employees who could be at risk of losing their jobs. The plan calls for leasing or outsourcing at 22 current VA sites, but the outline does not say how many jobs VA projects will be lost, the senators said in a letter to VA Secretary James Peake released on Oct. 29. The senators noted that it was quite late in President Bush’s administration for VA to propose such a major change in policy. “Any major shift in VA health care policy, especially one being proposed so close to the end of the current administration, requires open review by Congress and the public,” said Akaka. Among the questions they posed to Peake, the senators wanted to know about any studies of VA’s construction methods that have been carried out to determine if the current approach is as efficient as possible. They also inquired about the extent of the current backlog in VA construction, and about how much money VA would need over the next five years to complete all currently planned construction. To see more, go to: http://veterans.senate.gov/public/index.cfm?pageid=
12&release_id=11817.

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DOL Launches Month-Long Veterans Job Fair ‘Blitz’

The Department of Labor (DOL) announced on Oct. 29 the launch of a month-long blitz of more than 120 veterans job fairs to be held in 31 states as part of its “Hire Vets First” initiative. The effort begins on Oct. 24, and concludes at an event on Nov. 25 in Knoxville, Tenn. The job fairs aim to help newly separated veterans in their transition to civilian life. “The qualities America’s servicemembers are known for—discipline, strong work ethic, leadership and technical skills—are highly valued by employers,” said DOL Secretary Elaine Chao. A list of job fair locations by state—and more information about the campaign—are available at www.hirevetsfirst.gov. For more information on all of the veterans employment programs, go to: www.dol.gov/vets.

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