The Genomics and Personalized Medicine Act Needs a “Fresh Look”

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Now is the time for a national effort to move personalized medicine forward,” said Representative Anna Eshoo at the Center for the Study of the Presidency and Congress and Health Affairs’ Capitol Hill briefing held last week, on the same day that the Food and Drug Administration (FDA) released its plan Driving Biomedical Innovation:  Initiatives for Improving Products for Patients.

At the briefing, Congresswoman Eshoo affirmed the Personalized Medicine Coalition’s long-held contention that the 2010 version of the Genomics and Personalized Medicine Act needed an infusion of new ideas.  (See my blog post from August 23, 2011.)

Also speaking to the audience of congressional staff, reporters, patient advocates industry representatives, and others, were several government officials tasked with enforcing policies that affect personalized medicine innovation.  They presented their thoughts on the state of personalized medicine and their respective agencies’ roles, highlighting their progress. Both Janet Woodcock, M.D. and Elizabeth Mansfield, Ph.D. of FDA highlighted FDA’s efforts in bringing regulators and industry to the table to discuss the challenges of regulating personalized medicine products and services.  These discussions informed the agency’s new report—dubbed a blueprint for innovation—which includes major focus areas in building the infrastructure to drive and support personalized medicine and in creating a rapid drug development pathway for important targeted therapies.  They also acknowledged that changes are still needed at FDA to accommodate personalized medicine and that the agency will continue its leadership role by building a system to support the development of personalized medicines, including investments in regulatory science and by clarifying agency policies.

At the same time, Jeffrey Roche, M.D., M.P.H. from the Centers for Medicare and Medicaid services (CMS), underscored his agency’s time-consuming coverage decision-making process, which is based on published research used to determine what is “reasonable and necessary.”

Indeed more coordination is needed at the federal level.  Speakers representing academe, industry, and patients reinforced this sentiment, in addition to emphasizing the need for industry incentives to develop new products and services and a CMS reimbursement policy that can speed the adoption of personalized medicine by paying enough for personalized medicine diagnostic tests so that research and development costs are recouped.

Patient advocate and PMC-member Donna Cryer summed it up best, when sharing her thoughts on what can foster innovation and the adoption of personalized medicine: We need HHS level coordination, and a streamlined FDA process for personalized medicines and their diagnostic partners.  CMS needs to support the science of personalized medicine through a system of care that repays innovators for the research that goes into the development of these products.  And tax credits are necessary to help companies through what is still very difficult science. 

PMC is pleased by Rep. Eshoo’s leadership in advancing personalized medicine as evidenced by her participation in this event and her willingness to consider all of the policy proposals PMC and others have put forth.  We look forward to working with her to vet policy recommendations suggested by others and to see the Genomics and Personalized Medicine Act introduced in this Congress.

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