Statement of Policy requested for orphan drug products

National Organization for Rare Disorders (NORD) has recently asked the FDA for a Statement of Policy regarding the approval and regulation of orphan drug products. They believe that this would encourage companies to invest more in research and development for rare disorders. At the current moment, there is no policy for the review of drugs and biologics for rare diseases.

Frank Sasinowski, chairman of the NORD board of directors, stated:
“What is not often heard is the companion portion that completes that statement. While the statutory standards are the same, the FDA interpretation and application of those same standards have historically been tailored by FDA to the unique facts of each particular medicine under FDA review”.

Read the full article here.