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Congressional Hearing on Drug Import Safety

SOCMA’s Bulk Pharmaceutical Task Force to testify

FOR IMMEDIATE RELEASE

October 31, 2007, Washington, DC – The Synthetic Organic Chemical Manufacturer’s Association’s (SOCMA) Bulk Pharmaceutical Task Force will testify before the House Energy and Commerce Subcommittee on Oversight and Investigations November 1st at 10AM.  The title of the hearing is: FDA Foreign Inspection Program: A System at Risk. 

The BPTF will tell the Committee about the lack of government inspections of overseas facilities manufacturing the active ingredients that go into drugs.  These active ingredients are what make drugs work and the vast majority are made overseas. 

Council for SOCMA’s BPTF, John Dubeck, will testify that many active pharmaceutical ingredients (API’s) made in foreign facilities are rarely inspected by the Food & Drug Administration, especially in the case of ingredients going into over-the-counter drugs.  Under the law, domestic facilities before beginning manufacturing must be inspected.  The majority of foreign facilities manufacturing API’s used in generic medications rarely see an FDA inspector after an initial inspection.  Most foreign manufacturers of over-the-counter medication ingredients have never seen an FDA inspector.

About BPTF:    SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) is an industry trade organization for U.S. manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients.  Created in 2002 as an affiliate organization of SOCMA, its primary objective is to seek clarification of current regulatory requirements and to interact with governmental agencies on emerging issues that may impact SOCMA members. 

Note:       For more information on BPTF, including background documents describing the issue, please see: www.socma.com/bptf

What:      Congressional hearing titled: FDA Foreign Inspection Program: A System at Risk (http://energycommerce.house.gov/membios/schedule.shtml)

When:     Thursday, November 1, 10AM

Where:    2123 Rayburn House Office Building

Contact:  Gregory Minchak
                  minchakg@socma.com or 202.721.4182

    # # #

SOCMA is the leading trade association, serving the specialty-batch and custom chemical industry since 1921. SOCMA’s nearly 300 members employ more than 100,000 workers across the country and produce 50,000 products valued at $60 billion annually. For more information please visit www.socma.com.
 


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