American Society of Hematology Statement on Passage of Prescription Drug User Fee Act (PDUFA)

WASHINGTON, June 27, 2012 /PRNewswire-USNewswire/ -- On June 26, 2012, the Senate passed the final Prescription Drug User Fee Act (PDUFA) legislation, (The Food and Drug Administration (FDA) Safety and Innovation Act, S. 3187) including important provisions to mitigate drug shortages, most notably requiring manufacturers to provide advanced notification of stoppages or interruptions in production that could result in a drug shortage. The bill, which was passed by the House on Wednesday, June 20, will now go to President Obama for his signature. 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 country's recent spate of shortages 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 cancers.

Once signed into law, ASH believes this legislation represents an important first step in addressing the drug shortage crisis. However, the Society is disappointed that the final legislation did not include biologics in the list of drugs covered under the bill's early warning requirement for manufacturers. These drugs range from chemotherapeutic agents used to treat patients with blood cancers (biologics) to plasma protein therapy products and their recombinant analogs used for the treatment of hemophilia and other bleeding disorders. They are critical to the delivery of care for patients with blood disorders, and the non-inclusion of these drugs puts these patients in jeopardy.

In recent weeks ASH had been leading advocacy efforts to ensure that biological products were included in the bill's early notification requirement, and sought to remove the exemption of products derived from human plasma proteins and recombinant products replacing human tissue from the early reporting mandate in the House and Senate bills. Unfortunately, the final legislation does not include biological products in the advanced notification requirements, but it authorizes  the Secretary of the Department of Health and Human Services (HHS) to apply these requirements to biological products including plasma protein therapies and their recombinant analogs by regulation if it would benefit public health. ASH will continue its advocacy efforts with the Secretary and FDA to see that biologics are included in the advanced notification requirements through the regulatory process.

Over the past 18 months, ASH has worked closely with Congressional leaders as they developed the drug shortage provisions in the bill. ASH has made several recommendations on ways to prevent and mitigate shortages, and the Society's advocacy has been successful. The final bill includes several of ASH's key recommendations, including requiring that the Secretary disseminate information about drug shortages to patient and provider organizations; requiring enhanced inter-and intra-agency coordination and requiring increased and effective communication with outside stakeholders; and requiring that the strategic plan required by the bill include an evaluation of the impact of drug shortages on research and clinical trials.

ASH will continue to monitor all hematologic drug shortages closely and will continue to work with policy makers to prevent and mitigate drug shortages and protect the health of Americans.

The American Society of Hematology 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, the most cited peer-reviewed publication in the field, which is available weekly in print and online.

SOURCE American Society of Hematology



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