SOCMA Receives FDA’s Response To Citizen Petition

The Society of Chemical Manufacturers and Affiliates (SOCMA) has reported that the FDA has responded to its citizen’s petition after four years, calling on the agency to do more to ensure the safety of drug products imported to the US.

Socma said that the FDA has only made nominal increases in foreign inspections since 2007, and much more needs to be done.

Lynne Jones Batshon, manager of government relations at SOCMA, said: “We are pleased that the FDA has responded to our petition. 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, 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. There will always be an unlevel playing field unless the FDA considers risk-ranking foreign and domestic facilities together. 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. It suggested the agency to expand their existing impurity profile surveillance to identify patterns that might indicate manufacturing processes, that do not meet cGMP standards.