Navigation Links
IDSA Proposes New Pathway For Antibiotic Approval
Date:3/8/2012

WASHINGTON, March 8, 2012 /PRNewswire-USNewswire/ -- Congress will consider a new drug approval pathway to encourage development of critically needed, lifesaving antibiotics as part of a strategy to address the public health crisis of antibiotic resistance. The Infectious Diseases Society of America (IDSA) proposed the new pathway, the "Special Population Limited Medical Use (SPLMU)" mechanism, to provide an important new approval option for companies interested in developing drugs to treat patients with serious infections where few or no treatment options exist.

IDSA submitted the proposal to the House Energy and Commerce Committee Subcommittee on Health today during a hearing on the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) reauthorization legislation. During the hearing, lawmakers will consider whether to incorporate within PDUFA pending legislation known as the Generating Antibiotic Incentives Now (GAIN) Act, which proposes incentives to address the dry antibiotic research and development (R&D) pipeline. PDUFA is considered one of the few must-pass bills this year in Congress.

"Antimicrobial resistance is unequivocally one of the world's greatest public health threats, and we've been sounding the alarm about it – and the lack of new antibiotics in development – for years," said Brad Spellberg, MD, co-chair of IDSA's Antimicrobial Availability Task Force. "This new mechanism provides the opportunity to address this public health crisis while there is still time to fix it."

The SPLMU mechanism streamlines the approval pathway and enables pharmaceutical companies to study SPLMU drugs in far fewer patients than currently is required, more rapidly, and at significantly less cost – because they are intended for more targeted use within a special population of patients who lack other treatment options. SPLMU designation reserves a drug for use in specific populations in which the benefits outweigh the risks, and encourages prudent use of the drug to slow the rate of resistance.

"The proposed SPLMU drug approval mechanism will bring critically needed innovation to the anti-infective pipeline, encouraging antibiotic development and lowering the hurdles to getting these critically needed drugs to patients who desperately need them," said Robert Guidos, vice president of public policy and government relations at IDSA. "In addition, we've designed it to foster antimicrobial stewardship, so these drugs will be used only when appropriate, extending their lifesaving power."

To read the rest of this press release, click here: www.idsociety.org/New_Pathway_for_Antibiotic_Approval/.


'/>"/>
SOURCE Infectious Diseases Society of America (IDSA)
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Proposes Lower Risk Classification, Special Controls for External Pacemakers
2. FDA Proposes Guidelines That Clarify Benefit-Risk Determinations for Medical Devices
3. FDA Proposes New Policy for Some Diagnostic and Radiology Devices
4. Valeant Pharmaceuticals Proposes to Acquire Cephalon, Inc. for $73 Per Share in Cash
5. Mangrove Partners Proposes Fully-Financed Dividend Recapitalization to Board of CPEX Pharmaceuticals, Inc.
6. FDA Proposes Withdrawal of Low Blood Pressure Drug
7. American Association for Homecare Proposes Strong Anti-Fraud Measures in Medicare, Applauds HHS Testimony Today That Pledges to "Stop Fraud Before it Starts"
8. ActivBiotics Proposes Development Strategy for Its Novel Rifamycin Antibiotics
9. Cancer Cure Coalition Proposes Major Changes at the FDA
10. New Gene Study of ADHD Points to Defects in Brain Signaling Pathways
11. Functional Brain Pathways Disrupted in Children with ADHD
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)...   Science Exchange , the leading marketplace ... the first five replication studies from the ... in eLife today. Despite intense scrutiny around reproducibility ... evaluation of reproducibility rates that may identify specific ... assessments of reproducibility, the results of this project ...
(Date:1/19/2017)... January 18, 2017 , , Marks E-QURE ... distribution agreement, following similar agreements in Israel ... Wound care is $2 5 billion ... E-QURE Corp. (OTCQB: EQUR), a leader in medical devices for the treatment of ... Médica Equipos Médicos S.A.S. (TeckMedica) in Colombia for the ...
(Date:1/19/2017)... , Jan. 18, 2017 The drug ... billion by 2021 from USD 1,179.20 billion in 2016, ... Increasing prevalence of chronic diseases, increasing demand for ... factors driving the growth of this market. Whereas, self-administration ... generic drugs offer significant growth opportunities for players operating ...
Breaking Medicine Technology:
(Date:1/19/2017)... ... ... With the cold weather here, many people will have to clear snow with snow blowers ... of snow, but they can be dangerous when used incorrectly. That’s why Amica Insurance ... proper use of snow blowers:, , When removing wet snow or ...
(Date:1/19/2017)... ... ... Cosmetic Town, an online plastic surgery community, begins 2017 with an update ... their readers to get the information they desire. The procedures are now listed according ... on those particular areas. , “We are excited to streamline our listings in a ...
(Date:1/19/2017)... ... 2017 , ... Bio-Optronics Inc. is proud to announce the ... to seamlessly integrate and streamline the way researchers prepare and conduct patient visits. ... and improving efficiency significantly for users – a first in the CTMS industry. ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... staff members in 2017 who are passionate about making a difference in the ... and headquartered in Tampa, UMA, a nonprofit healthcare educational institution, has more than ...
(Date:1/19/2017)... ... 2017 , ... For the third year running, Noto Insurance ... surrounding area, is inaugurating a charity event to help raise funds for ... Gehrig's disease or motor neurone disease, is a deadly neurological disorder that affects ...
Breaking Medicine News(10 mins):