Coping with an increasingly global device and drug industry will require a paradigm shift that relies less on FDA’s own staff and more on data and resource sharing with other countries, the agency says.

U.S. regulators plan to outsource more inspections of overseas factories within the next decade after criticism from Congress about a lack of oversight for food and drugs made in other countries.

Reauthorization of FDA user fees, scheduled for consideration by Congress next year, is expected to pass on a largely bipartisan basis and is unlikely to involve the kind of political controversy currently surrounding the Obama administration’s healthcare legislation.

Wisconsin Congresswoman Tammy Baldwin is a leader in the effort to reopen the national health care debate in the arena of critical care – emergency or life-sustaining care provided in emergency rooms or intensive care units. The effort is led by a national panel of specialists and advocates, the Roundtable on U.S. Critical Care Policy. A lobbying firm employed by the group says its members formed in part because they felt critical care was overlooked in the reform of America’s health care system.