Navigation Links
SOCMA's Bulk Pharmaceuticals Task Force Welcomes House Passage of FDA Reform Act
Date:5/31/2012

WASHINGTON, May 31, 2012 /PRNewswire-USNewswire/ -- Just days after the Senate overwhelming approved legislation to better protect the nation's drug supply, the House of Representatives today followed suit, passing the Food and Drug Administration Reform Act of 2012 (H.R. 5651) in a 387-5 vote. The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), welcomed the vote and urged House and Senate conferees to quickly agree on a final bill for the president's signature.

H.R. 5651 includes authorization of the Generic Drug User Fee Act (GDUFA), legislation that would improve the drug supply chain by requiring inspection of all foreign and domestic drug production facilities. BPTF, a key industry stakeholder, has advocated since 2006 for increased resources for the FDA to conduct more inspections of foreign drug ingredient manufacturers, and they worked with other industry groups last year to negotiate the terms included in GDUFA.

"With today's vote, the U.S. will make significant strides in ensuring that our drug supply is less susceptible to sub-par drugs from facilities with lax quality compliance standards," said BPTF Chair Patty Benson, Quality Assurance Director of SAFC. "We urge quick action by both House and Senate conferees to agree on a final bill that the president can sign as soon as possible."

The generic drug industry will pay approximately $1.5 billion over five years in return for faster and more predictable review of generic drug applications, according to the terms of GDUFA. This will help reduce drug shortages and bring drugs to market faster. The legislation also allows the FDA to perform inspections on a risk basis, focusing on the facilities posing the greatest risk to drug safety.

BPTF is an industry trade group for manufacturers of active pharmaceutical ingredients, with the primary objective of seeking clarification of current regulatory requirements.

About BPTF
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of SOCMA, is an industry trade organization for manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients. 

Contact:
Christine Sanchez
Senior Manager, Public Relations & Media
(202) 721-4182
sanchezc@socma.com


'/>"/>
SOURCE Society of Chemical Manufacturers and Affiliates
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Lexicon Pharmaceuticals to present at the Jefferies 2012 Global Healthcare Conference
2. Hybrid Fuels, Inc. Announces Name Change to Nouveau Life Pharmaceuticals, Inc.
3. AcelRx Pharmaceuticals Announces Pricing of a $10.0 Million PIPE Financing
4. Isis Pharmaceuticals to Present at the Goldman Sachs 33rd Annual Global Healthcare Conference
5. Auxilium Pharmaceuticals, Inc. to Present at the Goldman Sachs Global Healthcare Conference 2012
6. Vanda Pharmaceuticals to Present at the Jefferies 2012 Global Healthcare Conference
7. Cannabis Science Gets Set to Release "Phytiva" Its Newest Brand of Over-the-Counter Skin and Nutraceutical Product Lines Through its Newest Venture Phytiva Pharmaceuticals Inc.
8. Oramed Pharmaceuticals Granted Core Technology Patent in New Zealand
9. Syndax Pharmaceuticals to Present Updated Overall Survival Data With Entinostat in Metastatic Breast Cancer at ASCO
10. Avanir Pharmaceuticals to Present at Jefferies 2012 Global Healthcare Conference
11. Endo Announces Resolution of Patent Litigation with Watson Pharmaceuticals Related to Lidoderm®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
(Date:10/7/2017)... , Oct. 6, 2017   Provista, a ... than $100 billion in purchasing power, today announced a ... information. The Newsroom is the online home ... trends, infographics, expert bios, news releases, slideshows and events. ... to a wealth of resources at their fingertips, viewers ...
(Date:10/4/2017)... , Oct. 4, 2017 ... single-use, self-contained, illuminating medical devices, today announced regulatory ... Health Surveillance Agency (or Agência Nacional de Vigilância ... first single-use, cordless surgical retractor with integrated LED ... optimal access, illumination and exposure of a tissue ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the Mission ... lost souls in the Philippines. “The Journey: From the Mountains to the Mission Field” ... the Bible. She has taught all ages and currently teaches a class of ladies ...
(Date:10/12/2017)... San Francisco, CA (PRWEB) , ... October 12, ... ... and Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus ... sleep apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... the introduction of an innovative new design of the shoulder pad. The shoulder ... maximum comfort while controlling your pain while using cold therapy. By utilizing ice and ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... for the 49th Congress of the International Society of Paediatric Oncology (SIOP) ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. ...
Breaking Medicine News(10 mins):