NORD Applauds NIH and FDA Joint Initiative

The National Organization for Rare Disorders (NORD) today praised the announcement by two of the nation’s leading health-related federal agencies of a new collaborative effort to accelerate the development of innovative medical treatments and more effectively evaluate new products to make them available to the public.

The joint initiative was announced by leadership of the National Institutes of Health (NIH), the nation’s primary medical research institution, and the Food and Drug Administration (FDA), the regulatory agency responsible for approving new products for marketing.

“We applaud the action of FDA and NIH in seeking to work together more closely to bridge the gap between promising early research and the development of marketable therapies,” said NORD President and CEO Peter L. Saltonstall. “Accelerating the development of safe, effective treatments is one of NORD’s primary missions. We’re very excited and encouraged by the announcement from FDA and NIH today.”

Representatives of NIH and FDA said the two agencies will establish a Joint Leadership Council to spearhead collaborative work on important public health issues. They will also make $6.75 available over the next three years for regulatory science research. Representing the agencies in today’s announcement were NIH Director Francis S. Collins, MD, PhD, and Margaret A. Hamburg, MD, Commissioner of Food and Drugs. Health and Human Services Secretary Kathleen Sebelius also participated in the announcement.

Saltonstall said that, while progress has been made in recent years, approximately 15 million Americans have rare diseases for which there still is no treatment. Patients who are treated off-label may encounter reimbursement and other issues, he said. “Eliminating any unnecessary roadblocks in the process is extremely important,” he said. “We are very encouraged by today’s announcement, and we stand ready to assist FDA and NIH in any way we can.”

Date Created: February 25, 2010