Putting Rare Diseases Patients First!® is pleased to announce the submission of a Citizen’s Petition to add Sickle Cell Disease to FDA’s Tropical Disease Priority Review Voucher List.
San Diego, CA, August 17, 2020 - Putting Rare Diseases Patients First!® is pleased to announce the submission of a Citizen’s Petition to add Sickle Cell Disease to FDA’s Tropical Disease Priority Review Voucher List. Dr. Lorna Speid, the Founder and President of the non-profit, and a Board-Certified regulatory affairs professional, says that she was surprised to find that Sickle Cell Disease was not already on the List. A Citizen’s Petition and White Paper were written to make the case for the addition. Dr. Speid explained that the motivation for the filing was the tremendous level of suffering experienced by the patients and families afflicted by this neglected tropical genetic disease.
Dr. Speid says that “Sickle Cell Disease ticks all the criteria set by FDA for addition to the List, including the fact that it afflicts a majority African American population in the US, and is highly prevalent in African countries”. This patient population suffers from inability to financially support the development of new medicines. The PRV List provides companies with a back-end reward in the form of a Priority Review Voucher that they can use on the review of a new high value drug.
Oluyemi Moses is the Senior Coordinator for Sickle Cell Disease, and a Board member at PRDPF! She is herself a long time Sickle Cell Disease Warrior. She says, “I come from a family where four of seven children were born with Sickle Cell Disease. The fact that two of my siblings have passed away from complications of Sickle Cell Disease, makes this an urgent matter for me. This opportunity for Sickle Cell Disease to be added to the Tropical Disease Priority Review Voucher List is not only important to me, but also to the millions around the world who suffer from this disease.”
The Docket can be found at Regulations.gov, under Docket Number FDA-2020-P-1674.
About Putting Rare Diseases Patients First!®
Putting Rare Diseases Patients First! ® is a 501 (c) (3) non-profit that seeks to empower patients with rare diseases, by providing information about the new medicine development process. Dr. Lorna Speid can be reached at LSPEID@PRDPF.ORG.
