FDA Responds to SOCMA's Citizen Petition

Trade Group Takes Wait-and-See Approach to Agency’s New Initiatives

October 28, 2009

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Washington, DC – The Society of Chemical Manufacturers and Affiliates (SOCMA) announced today, that after nearly four years, the Food and Drug Administration (FDA) has responded to its citizen’s petition, calling on the agency to do more to ensure the safety of drug products imported to the U.S.

“We are pleased that the FDA has responded to our petition,” said SOCMA’s Government Relations Manager Lynne Jones Batshon, who filed the petition on behalf of SOCMA’s Bulk Pharmaceuticals Task Force. “The agency has rolled out several initiatives since our request was submitted, and we hope that some of them resulted from the concerns we highlighted in 2006.”

Batshon added that while SOCMA supports all the efforts being made by FDA, the majority of the initiatives cited in the agency’s response were announced in April 2008 and thereafter.

“Right now we’re taking a wait-and-see approach to evaluating the effectiveness of FDA’s new initiatives, particularly their ability to conduct more foreign inspections,” she continued. 

Since SOCMA filed its citizen’s petition in January 2006, there have been several incidents in foreign nations that brought to light the risk to public health associated with contaminated or adulterated products.  Earlier this year, at least 84 Nigerian children died after taking teething medicine mixed with diethylene glycol - an industrial solvent used in antifreeze and brake fluid.  In 2008, health officials in China discovered that nearly 300,000 babies were affected by melamine-contaminated infant formula.   That same year, US officials uncovered a contaminate in the blood thinner heparin from China, that lead to four deaths and hundreds more to become ill.

SOCMA says FDA has only made nominal increases in foreign inspections since 2007 and much more needs to be done. 

“There will always be an unlevel playing field unless the FDA considers risk-ranking foreign and domestic facilities together,” said Batshon.  “The agency has cited a lack of resources for its decision to not risk-rank facilities together, which in our view, is not an adequate justification.”

Regarding monitoring impurity profiles, SOCMA disagrees with FDA’s assertion that conducting such surveillance would not be meaningful and suggests the agency expand their existing impurity profile surveillance to identify patterns that might indicate manufacturing processes that do not meet cGMP standards.


SOCMA is the leading trade association, serving the batch, custom and specialty 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.

ChemStewards® is SOCMA’s flagship environmental, health, safety and security (EHS&S) continuous performance improvement program.  ChemStewards was created from industry’s commitment to reducing the environmental footprint left by member’s facilities.  Industry created ChemStewards to meet the unique needs of the batch, custom, and specialty chemical industry. As a mandatory requirement for SOCMA members engaged in the manufacturing or handling of chemicals, ChemStewards is helping participants reach for superior EHS&S performance.  To learn more visit www.chemstewards.com