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FDA anti-adulteration efforts hindered by industry; GAO

By Nick Taylor, 28-Nov-2011

Related topics: Excipients, raw materials and intermediates, QA/QC, Regulations, Processing, Globalisation, Counterfeiting

Industry reluctance to share information on economic adulteration is hindering FDA efforts to tackle tainted ingredients, a GAO report found.

Since heparin contamination made economic adulteration a high-profile topic the US Food and Drug Administration (FDA) has upped action to tackle the problem. However, progress is being restricted by an unwillingness to share information.

“Industry is often reluctant to share such information when an adulterated ingredient has not entered into commerce”, a US Government Accountability Office (GAO) report found . Companies fear reporting a supplier could lead to a lawsuit if the accusation was later deemed to be unfounded.

Other decisions to withhold information from the FDA are motivated by fear of sharing proprietary knowledge. Tests developed by industry to check products from suppliers may be the best tools for detecting economic adulteration, the GAO wrote, but stakeholders said they are unwilling to share.

Industry is aware of the benefits of sharing but companies want a secure platform. Many feel the risks outweigh the benefits but adoption of a clearinghouse could increase industry confidence.

One option for greater communication that several stakeholders identified was the creation of an information clearinghouse, through which companies could anonymously share information on adulterated ingredients with FDA and other companies”, the GAO wrote.

Clearinghouse considerations

To ensure companies remain anonymous, particularly in sectors with few players, some said a third party should run the clearinghouse. Without taking this precaution the industry is concerned anonymity may be compromised by the presence of specific company identifiers in information.

Proponents of the policy said sharing macroeconomic information, such as price fluctuations and natural disasters, could benefit industry and the FDA. A stakeholder said a clearinghouse could have contained information, such as a sudden price change, to alert the FDA to the heparin adulteration.

The FDA has considered the idea. “FDA officials said that they are examining various ways to facilitate information sharing with industry and have discussed the idea of a clearinghouse, but they have no plans to develop one”, the GAO wrote.

FDA communication

While acknowledging the importance of industry sharing information, the GAO focused its report on internal matters at the FDA, particularly the need for better communication between its divisions.

Agency entities have missed opportunities to communicate and coordinate efforts specifically directed at economic adulteration and identify potential public health risks”, the GAO wrote.

Several FDA units have undertaken efforts specific to economic adulteration but failed to coordinate, despite using the same risk factors. A recently formed working group on economically motivated adulteration may help.

The GAO wrote: “FDA expects the efforts of the working group will result in enhanced collaboration and communication at FDA on ways to approach and address situations of economically motivated adulteration.”