* Authorizing FDA to require certification of designated high-risk products as an additional condition of importation.
* Authority to refuse admission of imports from a firm who delayed, limited, or denied FDA access to its facilities.
* Empowering FDA to issue a mandatory recall of food products when voluntary recalls are not effective.

"FDA's mission to protect and promote the health of the America public will be greatly aided by these additional funds to implement our strategic plan," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "FDA has already embarked on an ambitious program to transform the Agency. This added funding will ensure that FDA can move ahead with these proposals more rapidly."
Consistent with the Administration's emphasis on fiscal discipline, the budget amendment is fully paid for within budgetary totals.

The budget amendment proposes the following increases for core FDA programs:
Protecting America's Food Supply (+$125 million)

The increase allows FDA to intensify actions to implement FDA's Food Protection Plan. Announced on November 6, 2007, the Food Protection Plan is an integrated, risk-based strategy to help ensure the safety of domestic and imported food and feed. The $125 million increase adds to the $42.2 million increase proposed for food protection in the budget announced in February 2008.

The increase in food protection activities will allow FDA to reduce threats to the food supply, expand FDA's international presence, and increase technical assistance to help ensure that foreign and domestic food facilities comply with food safety standards. FDA will also be able to improve the risk-based approach it uses to conduct more targeted import exams and foreign and domestic inspections of food manufacturing, processing, and packaging facilities. FDA will pursue additional research on ways to prevent intentional and unintentional contamination, deploy screening technologies to identify microbial and chemical contamination, and respond more quickly to contain outbreaks of food-borne illness.
Safer Drugs, Devices, and Biologics (+$100 million)

The increase of $100 million for the FDA's medical product programs will strengthen FDA's ability to ensure the safety and effectiveness of medical products, from product development and pre-approval testing, through approval, and post-approval safety surveillance. FDA faces growing challenges from the globalization of medical product development and manufacturing. The increase for medical product programs will allow the FDA to respond to this trend.

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