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www.fdanews.com/articles/92276-insurers-push-for-new-body-to-study-efficacy-safety-of-drugs

Insurers Push for New Body to Study Efficacy, Safety of Drugs

April 20, 2007

America's Health Insurance Plans, a national association representing nearly 1,300 health insurance companies, has proposed a plan to establish a new entity to compare the safety and efficacy of new drugs.

The absence of objective, patient- and physician-friendly information related to the value of medical services has come under scrutiny recently as safety and efficacy concerns have arisen related to treatments such as Cox-2 inhibitors, the group said.

Key elements of the group's plan include: creating a national public-private partnership to evaluate which treatments are most effective and provide the best value; pushing for FDA reform to improve the agency's ability to assess the long-term safety and effectiveness of new drugs; and setting a national research agenda that addresses known gaps in evidence and makes communication about ongoing studies a priority.

"Improving the safety and quality of care will allow the nation to more quickly provide coverage to all Americans," Karen Ignagni, the group's president and CEO, said.