Thursday, October 30, 2008

FDA Shielding Drug Companies, Lost Press Freedom

Hot Docs: Is FDA Shielding Drug Companies From Lawsuits?; Presidential Transitions

Today's selection of timely reports

Posted October 30, 2008

FDA Changed Drug Labeling Rules to Help Manufacturers Avoid Lawsuits: In recent years, the Food and Drug Administration has changed its rules for drug labeling to help shield drug companies from lawsuits, a practice that a new House report calls "a serious abuse of the agency's public health authorities." The new labeling procedures require that important new information about drug interactions or side effects be approved by the FDA before it can be added to the label. A report prepared by the Democratic staff members of the House Committee on Oversight and Government Reform reveals that career FDA employees objected to these 2006 and 2008 changes in regulation but were overruled by Bush administration appointees. According to the House report, in at least two cases, manufacturers asked to update their labeling to warn of important, newly discovered health risks, but the changes were delayed for months by the agency's review process. The report asks "whether FDA has acted in the best interests of public health," saying, "The agency's actions have undoubtedly helped shield drug manufacturers from liability. According to the agency's own experts, however, they have done so at the cost of delaying the dissemination of important safety information to the public."

Press Freedom in the United States: The nongovernmental Freedom House praises the "strong tradition" of a free press in the United States but pauses to note that this freedom has been "under strain" over the past five years. A newly released chapter from the group's publication "Today's American: How Free" observes that "legal protections for journalists have weakened in recent years," "access to official information has been circumscribed, and reporters' ability to cover both foreign and domestic events has been, at times, curtailed." The report points to the tight restrictions placed after 9/11 as well as attempts by the administration "to control or influence news coverage" as factors that have caused this change. Freedom House also describes legal and economic challenges facing the press. Still, the report concludes that the fact that reporters continue to break important stories revealing government misdeeds "is perhaps the best evidence that the American press remains free and robust."

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