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February 2011

NORD Hosts Forum for FDA Commissioner and Patient Leaders

WASHINGTON, January 21, 2011— Food and Drug Commissioner Dr. Margaret Hamburg today conducted an unusual one-on-one dialogue with leaders of approximately 60 patient organizations at a forum hosted by the National Organization for Rare Disorders (NORD).

NORD organized the meeting so that Dr. Hamburg could share with the patient advocates her vision for FDA and hear directly from them their hopes, needs, and concerns.

“I come today to ask for your help, your guidance, and your support at this critical moment for FDA,” Dr. Hamburg told the patient leaders. “We welcome and depend upon input from organizations like yours.”

NORD President Peter L. Saltonstall assured the Commissioner that the patient community is eager to be involved and supportive of efforts to modernize and streamline the development of safe, effective treatments.

Dr. Hamburg said there are three areas she considers essential to position FDA for today’s needs and those of the future:

 to assure that FDA maintains “and earns every day” the trust and confidence of the American people

 to modernize regulatory science to better incorporate scientific advances and

 to address increasing globalization

“Many of the products we regulate today come from outside the country,” she said. “Of the active pharmaceutical ingredients in medical products Americans use, 80 percent come from outside the U.S.”

Dr. Hamburg emphasized the importance of engaging internationally to share scientific data, harmonize the regulation process, and assure that critical needs of patients and families are being met.

Questions from the patient advocates covered a broad range of topics, including how FDA determines the risk/benefit ratio when considering new products and how it communicates its expectations to those developing new products.

Dr. Hamburg assured the patient representatives that their voices are heard at FDA. She encouraged them to remain active participants in the regulatory process.

“Never underestimate the impact you bring to these issues,” she said.

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