PMC

"FDA houses the largest known repository of clinical data — unique, high-quality data on the safety, effectiveness and performance of drugs, biologics and devices, both before and after approval," the agency said in its priorities report. "Despite the availability of these data, questions about subpopulation responses and underlying placebo effects remain unanswered."

Patrick Terry, Walter Carney

At a luncheon hosted by the Personalized Medicine Coalition last week, FDA Commissioner Margaret Hamburg said the agency will release its drug/diagnostic codevelopment guidance this year, and discussed how personalized medicine can be advanced through a new NIH/FDA partnership.

A number of events and trends that arose last year, including the increasing prevalence of direct-to-consumer genomics firms and PGx programs initiated by pharmacy services providers, might just make 2009 the year personalized medicine really started to take hold in the public's mind.

Since the FDA's 2005 preliminary concept paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance. A new white paper from the Personalized Medicine Coalition points out the areas requiring additional regulatory and evidentiary clarity from the agency.

In an attempt to help guide healthcare stakeholders who wish to issue public comments to the interim final GINA rule, Johns Hopkins University's Genetics & Public Policy Center released a model document discussing GINA's underwriting restrictions and how they impact health risk assessments and wellness programs.

While DMAA and employer groups are urging for a moratorium on GINA fearing that the law's restrictions on "underwriting" activities will harm enrollment in wellness programs, personalized medicine advocates are concerned that any delay in implementing the law as is would harm adoption of personalized medicine and hinder participation in genetic research studies.

Studies on genomically defined subpopulations that would advance personalized medicine are "going to get lost in the wash by considering everybody equivalent, which we know they are not," Collins said at a colloquium on personalized medicine hosted by the American Association for the Advancement of Science.

Comparative effectiveness research that analyzes the efficacy and safety of a particular treatment in a genomic subgroup "should address strengths and limitations of this evidence, how specific it is for patient subgroups, and evidence gaps that are priorities for further CER," the report states.