A Third Seat at the Table: An Insider's Perspective on Patient Representatives‪.‬

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. At present, both parties are overly constrained. The agencies face too many "but what if?" disincentives: potential and unknown safety risks and the specter of adverse publicity. The sponsors are wary of investing time and resources in the absence of a defined regulatory pathway. Too often, inaction seems the safest course.