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)... 11, 2017  Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), ... in Las Piedras, Puerto Rico , ... Following a ... sustained minor structural damage, temporary loss of power and ... been completed, manufacturing operations have resumed, and the company ...
(Date:10/10/2017)... EXTON, Pa. , Oct. 10, 2017   ... leader in innovative solutions for injectable drug administration, today ... of West,s ID Adapter for improving the intradermal administration ... the Fourth Skin Vaccination Summit in May 2017 by ... Team Lead, Polio Department, World Health Organization (WHO), and ...
(Date:10/5/2017)... Oct. 5, 2017  In response to the ... and Maxillofacial Surgeons (AAOMS) released prescribing recommendations that ... be used as a first-line therapy to manage ... Recognizing the value and ... Paper "Opioid Prescribing: Acute and Postoperative Pain Management" ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... most popular and least understood books in the Holy Scriptures, Revelation. The Book of ... baffled scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in ... awarded a contract by the Center for Medicare and Medicaid Services (CMS). The ... enterprise use of Agile methodologies in a consistent and high value manner across ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history of ... Brink” is the creation of published author, William Nowers. Captain Nowers and his ... veteran, he spent thirty years in the Navy. Following his career as a ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... treating sleep apnea using cutting-edge Oventus O2Vent technology. As many as ... disorder characterized by frequent cessation in breathing. Oral appliances can offer significant relief ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company ... of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every ... meet the highest standard. , These products are also: Gluten Free, Non-GMO, ...
Breaking Medicine News(10 mins):