American Society of Hematology Statement on Senate Passage of Prescription Drug User Fee Act (PDUFA)
WASHINGTON, May 24, 2012 /PRNewswire-USNewswire/ — Today the Senate passed S. 3187, its version of the Prescription Drug User Fee Act (PDUFA) legislation including important provisions to mitigate drug shortages, most notably mandating an early warning system for manufacturers. ASH is the world’s largest professional society concerned with the causes and treatment of blood disorders, representing more than 14,000 members who specialize in blood cancers such as leukemia, lymphoma, and myeloma, as well as serious blood diseases such as hemophilia. The county’s severe shortage of more than 200 drugs has particularly affected ASH member hematologists and their patients because many of the drugs most vulnerable to shortages – older, generic sterile injectables – are used to treat blood disorders.
While ASH believes the Senate bill represents a helpful first step toward addressing drug shortages, the Society is concerned that the Senate bill exempts biologics from all provisions, and is particularly disturbed that products derived from human plasma proteins and recombinant products replacing human tissue – products used for the treatment of hemophilia and other bleeding disorders – are specifically exempted from the early reporting mandate in the legislation. ASH is currently working to ensure that biologics, including human plasma protein derivatives and recombinant products are included in the final PDUFA legislation.
Over the past 18 months the Society has advocated for legislation to combat drug shortages. ASH has made several recommendations on ways to prevent and mitigate shortages, including to: increase FDA authority, require that the Secretary disseminate information about drug shortages to patient and provider organizations, enhance inter and intra agency coordination on drug shortages, require that the Agency Strategic Plan consider the impact of drug shortages on research and clinical trials, examine the impact of current FDA requirements on shortages, and provide economic incentives to manufacturers of critical drugs.
ASH will continue to monitor all hematologic drug shortages closely and will continue to work with policy makers to further strengthen the PDUFA legislation to protect the health of Americans.
The American Society of Hematology (www.hematology.org) is the world’s largest professional society concerned with the causes and treatment of blood disorders. Its mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems by promoting research, clinical care, education, training, and advocacy in hematology. The official journal of ASH is Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field, which is available weekly in print and online.
SOURCE American Society of Hematology