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SOCMA's Bulk Pharmaceuticals Task Force Supports Senate Drug Safety Bill

Article-SOCMA's Bulk Pharmaceuticals Task Force Supports Senate Drug Safety Bill

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), today announced its support for a new drug safety bill that would give the Food and Drug Administration (FDA) greater authority to protect the U.S. drug supply.

The legislation, known as the Drug Safety and Enhancement Act of 2010, is spearheaded by Senator Michael Bennet (D-CO). 

“SOCMA and the BPTF thank Senator Bennet for introducing this common sense legislation which will strengthen the FDA and increase public health and safety by providing additional quality controls on drugs and their ingredients,” said BPTF chairman Brant Zell of Cherokee Pharmaceutical. “Today, about 80 percent of active drug ingredients come from overseas – the majority from India and China – yet receive less than five percent of FDA’s resources. This bill is a good starting point in giving the FDA more authority, tools and resources to help ensure a safer U.S. drug supply.”

Zell said the lack of FDA inspections at foreign facilities, authority, resources, and management has led to significant risks to the nation’s medicines. While U.S. manufacturers face strong FDA oversight and enforcement, their counterparts in India and China have little or no oversight from the FDA or a comparable agency, creating a difficult and unfair situation for American companies.   

While praising the legislation, SOCMA’s president and CEO Lawrence D. Sloan emphasized the need for support by more US manufacturers to get behind SOCMA’s drug safety efforts.

“We can neither expect to achieve a safer drug supply chain nor expect fairer treatment by FDA unless more drug ingredient manufacturers join the effort led by BPTF,” said Sloan. “We need the support of these manufacturers to help take our message to Washington and pass meaningful legislation like Senator Bennet’s bill.”

Sloan commended BPTF for leading the effort for stronger drug safety laws and specifically for submitting a citizen petition in 2006, requesting the FDA take action to better manage the risks to public health associated with drugs from overseas.

BPTF is an industry trade organization for U.S. manufacturers of active pharmaceutical ingredients, 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.
SOCMA is the only U.S. based trade association dedicated solely to the batch, custom, and specialty chemical industry. Since 1921, it has represented a diverse membership of small, medium, and large chemical companies, making it the leading authority on this sector. SOCMA has a global membership of more than 200 companies. In the U.S., members employ more than 100,000 workers across the country and produce 50,000 products valued at $60 billion annually. For more information, visit www.socma.com.

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