Increasing Drug & Device Complexity: Impact on the U.S. Regulatory Review Process

December 8th, 2010
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Last week, PwC issued a report entitled “Improving America’s Health V—A survey of the working relations between the life sciences industry and FDA.” In a release announcing the report, PwC explained,  “Growing public demand for increased medical device and drug safety, as well as the need to develop medical products faster, is complicating the current regulatory approval process and relationship between the life sciences industry and its chief regulator, the U.S. Food and Drug Administration.”
I certainly agree that the FDA as a resource is constrained. This is a somewhat predictable predicament, however, in that products being considered for marketing approval as well as those currently regulated by the FDA are more complex today than ever before. As complexity rises, the agency clearly needs more resources and augmentation in specific skill areas, such as informatics and genomics.

I was somewhat encouraged at the FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests (LDTs) held in July that the Agency proposed to regulate based on “risk.” Although “risk” was not specifically defined, I feel we can reasonably assume that it is a function of the extent to why the test result is (exclusively) relied upon for a specific diagnosis or treatment plan (i.e., How bad are the consequences of being wrong? Are there other tests done in parallel?). This does, I believe, provide useful guidance to industry and service providers, and I anticipate seeing this practice tested in the spring.
How is your company facing current and future regulatory hurdles? Are complicating regulatory targets slowing your progress? We’d love to hear from you and to help you strategize and plan. Feel free to share your comments below or to contact us at

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About the Author:

I founded Popper and Company with Ken Walz more than ten years ago to address inefficiencies in health care by helping life science companies develop and commercialize new technology. Today, the members of our growing team leverage their extensive knowledge of the tools and trends shaping all aspects of health care and its participants. Send me an email.