By Julian Pecquet - 10/11/11 04:31 PM EDT
• development of a "qualitative framework for risk-benefit assessment" of new drugs and devices;
• adoption of a "more flexible benefit/risk paradigm";
• explicit consideration by the FDA of the impact of its decisions on medical innovation; and
• expansion of the FDA's Accelerated Approval pathway, which allows for faster approval of drugs and devices based on "surrogate endpoints" — such as shrinkage of a cancerous tumor — rather than real health benefits that might not be apparent for many years.
Consumer advocates, however, have raised concerns that quicker reviews could be harmful to patients.
Critics have also questioned some of the industry's data. In particular, Democrats on the House Energy and Commerce Committee during a recent hearing skewered industry-funded studies that argue medical device approval is slower and more convoluted in the U.S. than in Europe.