Washington, DC - March 5, 2010 — FDA Commissioner Dr. Margaret Hamburg addressed more than 150 leaders from industry, government and academe at the 6th Annual State of Personalized Medicine luncheon, hosted by the Personalized Medicine Coalition (PMC) February 25 in Washington, D.C. In her talk, entitled "Bringing Home the Genome: the FDA's Role in Realizing Personalized Medicine," Dr. Hamburg said that personalized medicine is "likely to be one of the most important themes for healthcare in the future," promising not only better and safer treatments for patients, but also potentially lowering overall healthcare costs. Dr. Hamburg also discussed the need for intra-agency communication and evolved regulatory policy, and committed to developing a draft guidance on companion diagnostic regulation by the end of 2010.

Dr. Hamburg stressed the need for intra-agency commitment to incorporating companion diagnostics testing in the drug approval process. She acknowledged that the successful adoption of personalized medicine approaches will require clear and consistent direction from the FDA to define expectations and approval standards for both diagnostic and pharmaceutical products.

"As Commissioner, it is clear to me that we need to develop a consistent, comprehensive and integrated approach to the evaluation and regulation of medical products which separately, and in combination, comprise the practice of personalized medicine," said Dr. Hamburg.

Dr. Hamburg also affirmed her personal commitment to creating a regulatory structure which is nimble, transparent and equipped to take advantage of drug development and delivery. "Just as biomedical research has evolved in the past decade, regulatory science – the science and tools we use to assess and evaluate a product's safety, effectiveness, potency, quality and performance – must also evolve."

Unclear federal regulation of diagnostic tests used in companion therapeutic-diagnostic products has often been cited as a barrier to developing personalized medicine products. At the suggestion of the FDA, the PMC convened a workgroup of pharmaceutical companies, diagnostic kit manufacturers and laboratories to study regulation of such products. In December 2009, PMC recommended that regulation must recognize the various types of companion products and address all of them; oversight must be developed through an open and transparent process; and regulatory policy should promote rapid access to new diagnostic information to improve clinical care and sustain innovation.

"The Personalized Medicine Coalition is encouraged by Dr. Hamburg's leadership and her commitment to advancing personalized medicine, notably her call to action on developing guidelines for companion diagnostic products," said Dr. Edward Abrahams, President of PMC. "We in the personalized medicine community look forward to working with the FDA to establish a clear regulatory pathway and policies that will encourage companies to invest in innovative approaches, ultimately leading to safer and more effective therapies."

Dr. Hamburg's remarks came on the heels of the announcement of an unprecedented collaboration between FDA and NIH aimed at accelerating the regulatory process timeline from discovery to delivery of promising new therapies to patients. She also noted that the Agency looks forward to working with the PMC as the Coalition and its members move forward to bring about change.

The event was sponsored by The Friends of the Personalized Medicine Coalition. Dr. Hamburg was introduced by Ralph Snyderman, Chancellor Emeritus of the Duke University Health System. A complete transcript of Dr. Hamburg's remarks is available at http://www.personalizedmedicinecoalition.org/emedia/2010-02-25/PersonalizedMedicineCoalition-February25-2010-Hamburg.pdf.

Communications/Media Inquiries
Liza Morris
Acting Communications Director
Phone 202-251-8287
liza.morris@PersonalizedMedicineCoalition.org

About the Personalized Medicine Coalition
The Personalized Medicine Coalition (PMC), representing a broad spectrum of academic, industrial, patient, provider, and payer communities, seeks to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients. For more information on the Personalized Medicine Coalition, please visit www.PersonalizedMedicineCoalition.org.