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Patricia O'Connell
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Sonali Gunawardhana Discusses Debate Over FDA Preventive Control Rule

Inside Health Reform
April 5, 2013

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted in a March 29 Inside Health Reform article about the debate over whether new U.S. Food and Drug Administration (FDA) regulations should include testing and supplier verification provisions.

Recently released documents reveal that the White House Office of Management and Budget omitted language related to testing and verification requirements in its review of the FDA’s preventive controls rule proposal submitted in January. The rule is part of a series the agency has crafted in the past year under the Food Safety Modernization Act, originally passed in 2010.

Food safety advocates and industry stakeholders have suggested that the removed language should be added back into the final version of the rule. However, trade associations such as the Grocery Manufacturers Association and the Food Marketing Institute argue stakeholders would require a chance to comment before signing off on changes to the current proposal.

Ms. Gunawardhana, who served as an FDA attorney for nearly a decade before joining Wiley Rein last year, warned the agency would be violating rulemaking procedure should it restore its original language without offering time for feedback, thus leaving itself open to legal action. However, Ms. Gunawardhana told the publication that history suggests the debate will not take such a dramatic turn.

“The food industry historically has not been very litigious when dealing with the FDA, rather they tend to be more collegial when working with each other,” she said. “They may grin and bear it.” Ms. Gunawardhana added the FDA could also just opt to leave the contested language out and put its focus on controlling produce hazards.