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Essay
A Third Seat at the Table: An Insider's Perspective on Patient Representatives We should put decisions in the hands of those most affected.

As the nation takes a fresh look at all aspects of medical care, advances in the health sciences—from genetic sequencing to stem cell technology—may give us opportunities to make health care better, faster, and more cost-effective. But first we must transform our approach to health care innovation, particularly in the regulation of new products that may signal clinical breakthroughs.

These issues intersect at the table where federal agencies, particularly the Food and Drug Administration, and innovative product development companies negotiate the regulatory approval process. But it is the people most directly impacted by disease, patients and their families, who have the greatest stake in the approval process. Their lives, and their quality of life, hang in the balance. They are in the best position to weigh actual risks and benefits. It is time to give patients, through carefully selected representatives, a seat at the regulatory approval table. If they serve as mediators, not just advisers, they can help regulators and companies identify new pathways for fostering innovation, building public trust, cutting costs, and addressing quality-of-life issues.

As the nation takes a fresh look at all aspects of medical care, advances in the health sciences—from genetic sequencing to stem cell technology—may give us opportunities to make health care better, faster, and more cost-effective. But first we must transform our approach to health care innovation, particularly in the regulation of new products that may signal clinical breakthroughs.

These issues intersect at the table where federal agencies, particularly the Food and Drug Administration, and innovative product development companies negotiate the regulatory approval process. But it is the people most directly impacted by disease, patients and their families, who have the greatest stake in the approval process. Their lives, and their quality of life, hang in the balance. They are in the best position to weigh actual risks and benefits. It is time to give patients, through carefully selected representatives, a seat at the regulatory approval table. If they serve as mediators, not just advisers, they can help regulators and companies identify new pathways for fostering innovation, building public trust, cutting costs, and addressing quality-of-life issues.

Duane Roth, "A Third Seat at the Table: An Insider's Perspective on Patient Representatives," Hastings Center Report 41, no. 1 (2011): 29-31.