Navigation Links
American Society of Hematology Statement on House Passage of Prescription Drug User Fee Act (PDUFA)
Date:5/31/2012

WASHINGTON, May 31, 2012 /PRNewswire-USNewswire/ -- Today the House passed H.R. 5651, 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 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 disorders.

While ASH believes the House bill helps address drug shortages, the Society is concerned that it specifically exempts products derived from human plasma proteins and recombinant products replacing human tissue – products used for the treatment of hemophilia and other bleeding disorders – from the early reporting mandate in the legislation. ASH is currently working to ensure that 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 recommenda     tions 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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Aspirin Named 8th World Wonder by Majority of Americans
5. MedImmunes Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
7. TrialCheck(R) Cancer Clinical Trial Matching Interface to Debut on American Cancer Society Web Site
8. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
9. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
11. New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... 22, 2017 Oncternal Therapeutics, Inc., a ... rare and common malignancies, today announced the closing ... company intends to use the proceeds to further ... to advance preclinical development of a new ROR1-targeted ... a first-in-class anti-ROR1 monoclonal antibody being developed to ...
(Date:2/22/2017)...  CVS Pharmacy is the first national retail pharmacy ... (PHO), the primary source of artificial trans fats in ... products. The retailer now offers over 600 exclusive snack ... fats. This comes a year and a half ahead of ... for processed foods to be reformulated without artificial trans ...
(Date:2/22/2017)... 2017 Des scanners sur smartphone destinés aux professionnels ... Europe , au Moyen-Orient et en Afrique  ... Clarius Mobile Health , une société de santé ... au Canada , a annoncé aujourd,hui qu,elle a reçu ... fil Clarius C3 et L7, destinés à être utilisés par des professionnels ...
Breaking Medicine Technology:
(Date:2/22/2017)... (PRWEB) , ... February 22, 2017 , ... The SeniorCare ... the 2017 Forecast —on Thursday, February 23, 2017, at 1:00 PM ET. A recording ... is part of the Interactive Webinar Series. , If you want to find out ...
(Date:2/22/2017)... ... 22, 2017 , ... Social media marketing is transitioning from a singular person ... & Jones’ delves into this insight and more in its latest episode of its ... Vener meets up with social media strategist and partner of the digital firm Med|Ed ...
(Date:2/22/2017)... ... 22, 2017 , ... In today’s world, homeowners face a ... market, it is easy to start feeling frustrated and confused. To help Dallas ... security consultation. , Home Security Hardware Choices, There are innumerable choices for home ...
(Date:2/22/2017)... ... February 22, 2017 , ... Apptricity® Corporation, a leading global ... management, today announced that Keppel Corporation has selected Apptricity Travel and Expense Management ... “We are excited to announce the partnership between Keppel and Apptricity for our ...
(Date:2/21/2017)... ... February 21, 2017 , ... Robins & ... in Durant, Oklahoma, on Feb. 21. , The celebration began with a ribbon ... clinic employees, the construction team and tribal leadership. , Choctaw Nation Durant ...
Breaking Medicine News(10 mins):