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Patricia O'Connell
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Sonali Gunawardhana Discusses Congress’s Push for Revised FDA Food-Safety Proposal

FDA Week
January 17, 2014

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted today in an FDA Week article about congressional appropriators’ request for the U.S. Food and Drug Administration (FDA) to include an updated cost analysis and product-testing requirements in its preventive controls proposal.

The FDA proposed the food-safety measure last year.  In a statement that accompanied the omnibus 2014 spending package, the lawmakers urged the FDA to re-propose the rule with more details on costs and testing, FDA Week reported.

The FDA has repeatedly told stakeholders it plans to include the testing provisions in the final preventive controls rule, and the congressional request bolsters the agency’s argument for such requirements, said Ms. Gunawardhana—a former top FDA attorney.  While the lawmakers’ language is an “informal” request for an initial FDA analysis, the agency will probably comply since it wants to see continued increases in food-safety funding, she said.

“There is always this fear at the agency that if you don't do what Congress told you to do, you won’t be funded appropriately,” Ms. Gunawardhana said.

The FDA will likely move forward in the “easiest and cleanest” way and could propose the testing requirements this summer, separate from the preventive controls proposal, she said.  She predicted that the agency will try to work more closely with industry on the proposal, since key industry groups have expressed concerns that the FDA might propose the rule without providing enough details about the testing.