President Bush has asked Congress to increase the US Food and Drug Administration (FDA) budget for next year by an extra 275 million dollars; the plea comes during a nationwide outbreak of salmonella food poisoining from suspected raw red tomatoes and a year marked by difficulties in regulating imported drugs such as the Chinese heparin that has been linked to dozens of deaths and hundreds of people with serious side effects.

The White House originally asked for the FDA's budget to be raised by 5.7 per cent to 2.4 billion for the next fiscal year starting in October. The extra 275 million is to enhance federal food safety programs, said US Health Secretary Michael Leavitt on Monday, according to a Reuters report.

"This additional funding will allow FDA to more rapidly take the steps necessary to meet the challenges of changing global markets and to better protect the American people," Leavitt told the press during a conference call.

Leavitt urged Congress to act quickly on the proposed budget amendment. Changes to the law to strengthen FDA powers are also being proposed by the Administration.

With the extra money the FDA could upgrade its information technology, better monitor foreign food, increase inspection of factories overseas that make medical products for the US market, and give better technical support to countries that ship products to the US, explained Leavitt.

According to an FDA press statement, the extra funds will support the food and medical product import safety framework proposed last year.

"These are not dollars these are additional people that the FDA will be able to hire with extraordinary expertise," said FDA commissioner Andrew von Eschenbach, who was also on the conference call. He said the extra 275 million would allow the agency to recruit another 490 staff members.

The FDA said in a news release on Monday that the action reflects the fundamental changes the agency is undergoing as it adapts to the "demands of the rapidly growing and changing global economy". The changes are outlined in the agency's Action Plan for Import Safety and the complementary Food Protection Plan, both of which were released last November.

In the news release Leavitt said that the FDA is moving from intervention, "where we stand at the border and try to catch things that are unsafe", to a mix of prevention with verification, by "rolling the borders back and seeking to build safety and quality into products at every step of the way before they reach American consumers".

Leavitt urged Congress to act quickly and approve the budget increase and legislative changes that will "give FDA the authority and funding it needs to enhance the safety of our food and medical products".

The FDA said that among other things, the budget increase will help the agency: Establish a presence in 5 countries or regions outside America.
Ensure greater foreign compliance with FDA standards.
Offer expedited entry for goods that are certified by trusted parties.
Modernize its information technology systems.
Carry out at least 1,000 more foreign inspections of food and medical product facilities.
Carry out at least 1,000 more domestic inspections. Bush has also asked Congress to give the FDA authority to: Accredit highly qualified third parties to check for compliance to FDA standards.
Require that certain high risk products also carry certification before they can be imported to the US.
Refuse imports from firms who delay, limit, or deny the FDA access to their facilities.
Issue mandatory recalls of food products when voluntary recalls are not working. Von Eschenbach said that: "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."

About one quarter of every dollar spent by consumers in the US goes on pharmaceuticals, medical devices, food, cosmetics and other products regulated by the FDA, representing about 1 trillion dollars of the US economy, according to a Reuters report.

Click here to read "Investing in FDA's Transformation", an outline of the agency's new way of operating.

Click here for more details of what the extra proposed 275 million in the FDA budget is for (scroll to bottom half of page).

Source: FDA, Reuters.

: Catharine Paddock, PhD