SOCMA to pursue emerging market quality issues

30 January 2008 21:19  [Source: ICIS news]

NEW ORLEANS (ICIS news)--The Synthetic Organic Chemicals Manufacturers Association (SOCMA) will pursue US legislation to address product quality issues arising from emerging markets, organisation board chairman Charles Hinnant said on Wednesday.

“SOCMA continues to support increased inspections of foreign facilities manufacturing active pharmaceutical ingredients [APIs] and wants to see the FDA [Food and Drug Administration] become more forward thinking in finding innovative solutions to the problem,” Hinnant said at the Informex USA custom chemicals manufacturers trade show.

SOCMA released the results of a member survey indicating the quality of chemicals sourced from emerging markets was declining.

Hinnant, who is chairman and CEO of Optima Chemical Group and president and CEO of Charkit Chemical Corporation, said the issue of product quality has been the subject of Congressional hearings. “These have featured the FDA, advocacy groups and industry groups – including SOCMA – in an attempt to find a solution on the issue,” he said.

SOCMA President Joe Acker cautioned that Congress wasn’t likely to take action on the issue this year, given the US presidential elections.

Acker added that the FDA recently was subject to a scathing report by the FDA Science Committee, an independent panel that criticised the administration’s management practices, inspections policy and methods of approving new drugs.

Acker said he hoped that the new US president in 2009 would not simply “throw money” at the FDA to fix the perceived problems, but would work to reorganise the administration.

The Informex trade show runs through Friday.

By: Brian Ford
+1 713 525 2653

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