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:2/11/2016)... North America , ... The global market is expected to reach USD 20,190.1 Million by ... of 10.2%. --> North America , ... MarketsandMarkets, The global market is expected to reach USD 20,190.1 Million ... CAGR of 10.2%. --> According to a new market ...
(Date:2/10/2016)... , Feb. 10, 2016  Fotona, based in the ... will launch its new ST PRO Lightwalker dental laser at ... Dental Society from 25-27 February, 2016 in booth #4815. The ... dental laser with many of the features of the award ... the ST PRO competitive price will be very attractive to ...
(Date:2/10/2016)... Feb. 10, 2016 Mylan N.V. (NASDAQ, TASE: MYL) ... year ended December 31, 2015. --> ... adjusted total revenues of $9.45 billion, up 28% on ... total revenues of $9.43 billion. Excluding the impact of ... and branded generics business (the "EPD Business"), full year ...
Breaking Medicine Technology:
(Date:2/11/2016)... , ... February 11, 2016 , ... The annual list ... on evaluation of DataPoint’s team dedication and commitment to the SharePoint ecosystem. ... the annual list. The panel’s goal is to recognize and promote technology entrepreneurship. ...
(Date:2/11/2016)... ... February 11, 2016 , ... Be Well Medical Group ... the heart of Old Town at 108 South Columbus St, Suite 201, Alexandria, VA. ... level of medical care in the convenience of their homes, offices or at the ...
(Date:2/11/2016)... ... February 11, 2016 , ... ... and ergoFET force gauges used in physical therapy, occupational therapy and sports medicine ... for resistance cord exercise and therapy, introduces its new microFET Digital Pinch Gauge. ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... ... have become more actively engaged in health and wellness best practices in the ... of riding this trend. February is American Heart Month, which acts as an ...
(Date:2/11/2016)... PORTLAND, Ore. (PRWEB) , ... February 11, 2016 ... ... found Medicaid coverage results in significantly higher rates of several common cancer screenings, ... early, resulting in better outcomes and survival rates. , The study,“What Does ...
Breaking Medicine News(10 mins):