The traditional tools of a regulatory agency are regulation, approval or disapproval of applications, and enforcement. As a public health agency, the FDA should always ask whether delays in approval or safety problems can be prevented — a mandate that requires extensive and creative engagement with regulated industries, patient and consumer groups, and others. The FDA should actively pursue opportunities to help advance science in the domains it regulates and address threats to the safety of medical products and food — even if those opportunities and threats lie outside the realm of the agency's usual routines. We expect to collaborate with other federal agencies and outside partners to address problems that the agency cannot solve alone.
Physicians should first help to create a shared vision that could overcome doctrinal divides — and bring providers together to create a system better aligned both with public needs and with providers' fundamental interests and values. The starting point is to recognize, as most physicians do, that improving a complex health care system requires action on multiple fronts. In its landmark report Crossing the Quality Chasm, the Institute of Medicine (IOM) described a "chain of effect" that links systems at four different levels as the interrelated determinants of health care quality that must be aligned for reform to yield the desired results.
Medical liability reform has garnered relatively little attention in the past two congressional sessions — in striking contrast to its prominence in previous federal health policy debates. The ebbing of the recent malpractice insurance "crisis" may have undercut momentum for liability reform, but a more important explanation relates to the politics of the issue. Tort reform has long been a Republican issue; Democrats have been suspicious of reform proposals and, perhaps, mindful of the heavy support they have received from the trial bar. With the turnover of the House (in 2007) and the Senate (in 2009) to Democratic control, liability reform has been submerged. The question now is whether health care reform changes the political calculations around the issue.
In their quest to enact health care reform legislation, Democrats' major challenge is securing the money to pay for greatly expanded insurance coverage and more government regulation in the face of strong Republican opposition and an unsettled private sector.