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

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."

Presidential Transitions: A new Congressional Research Service report, made available by the Federation of American Scientists, looks at recent historical precedents to consider how the presidential transition may play out. The issues of succession, continuity, and budgeting can be tricky, particularly when the incoming and outgoing chief executives are of different parties. A lame-duck president may push through last-minute rules, appointments, and executive orders in an attempt to cement his legacy, while the new president may do the same to establish the tone of the administration quickly. The report advises Congress that national security must be an "overarching concern" throughout the transition process but that its role should be to evaluate and examine new political appointments, budgeting, agency rules, and the preservation of records.

Negroponte Discusses Foreign Policy: Deputy Secretary of State John Negroponte says that the top foreign policy priorities of the next administration should include continuing the effort against terrorism and helping to build a strong Pakistan. In a speech to the Baltimore Council on Foreign Affairs, Negroponte says that how those issues are handled will dictate "the shape of the international order and the nature of American power, security, and prosperity" in the future. Negroponte stressed the importance of the United States in global leadership and the role that the U.S. government and international affairs organizations play in educating Americans about it.

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."

Crisis in the Congo: Despite strides made over the past decade, the Democratic Republic of the Congo today "remains unstable and the humanitarian catastrophe continues." In a paper for the Council on Foreign Relations, Anthony Gambino describes the "two central challenges" facing the African nation: violence in the eastern part of the country and exploitation of its abundant natural resources. He calls upon the United States to support the United Nations peacekeeping forces already at work within the country and to push for further actions if necessary. Meanwhile, he asserts, the United States should promote "broad-based, environmentally sound sustainable development" in order to fight poverty, promote democracy, and protect natural resources in the Congo. "The relatively modest commitment of American diplomatic and financial resources would lead to long-term benefits in terms of American interests and values," he says, while "the benefits to the people of the Congo would be incalculable."