We are very pleased to announce that the Administration has taken the highly unusual step of amending its FY 2009 budget to include an additional $275 million for the FDA.
Last month we let you know the Food and Drug Administration (FDA) Chief, Andrew Von Eschenbach, wrote a letter to Senator Arlen Specter (R-PA) expressing the dire need of an influx of $275 million. This was very unusual for a political appointee to go against the proposed budget of the President.
In a statement released from the Department of Health and Human Services (HHS) these additional funds will support framework to enhance import safety presented last year.
Under the budget amendment, FDA will be able to expedite steps to improve import safety, including:
* FDA will significantly expand its reach beyond American borders by establishing a presence in five countries or regions and by implementing other measures that will help ensure greater foreign compliance with FDA standards.
* Another initiative will offer expedited entry for goods bearing certification by trusted parties.
* FDA will modernize its information technology infrastructure.
* Finally, FDA will conduct at least 1,000 more foreign inspections of food and medical product facilities and an additional 1,000 domestic inspections with funds in the budget amendment.
The increase brings the Administration’s total proposed increase in the FDA’s budget for FY 2009 to $404.7 million – a 17.8% boost in funding from FY 2008.
Some new authorities requested for federal agencies in the Action Plan for Import Safety that Congress has not yet granted include:
* Authorizing FDA to accredit highly qualified third parties to evaluate compliance with FDA requirements.
* 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.
Last month Senator Herb Kohl (D-WI) offered an amendment to the FY 08 Emergency Supplemental Appropriation bill that would give an additional $275 million to the agency. It is currently unclear how this action by the Administration will affect this amendment.