Additional Funding for FDA to Improve Food and Medical Product Safety
HHS Secretary Leavitt announced that the Administration is
amending its budget request for fiscal year (FY) 2009 to include an
additional $275 million for the U.S. Food and Drug Administration
(FDA). He called on Congress to act quickly on this budget amendment
and pending Administration legislative proposals to strengthen FDA.
The action supports the fundamental change in strategy currently underway
at FDA to adapt to the demands of the rapidly growing and changing
global economy. These funds will expedite implementation of the
strategy outlined in the Action Plan for Import Safety and the
complementary Food Protection Plan, both released in November 2007.
year we outlined important changes in how this nation deals with
imports. We are moving from an intervention strategy -- where we stand
at the border and try to catch things that are unsafe -- to an
integrated strategy of prevention with verification. We are rolling the
borders back and seeking to build safety and quality into products at
every step of the way before they reach American consumers,” Secretary
The Secretary continued, “Combined with crucial
legislative proposals, this increase will allow FDA to continue to
transform its regulatory strategies to meet the challenges of the
evolving global marketplace. I urge Congress to act quickly to give FDA
the authority and funding it needs to enhance the safety of our food
and medical products.”
Under the budget amendment, FDA will be able to expedite steps to improve import safety, including:
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.
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 percent boost in funding from FY 2008.
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.
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)
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)
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.
more aggressively conduct active safety surveillance to identify early
signs of adverse events linked to medical products. FDA will also
implement new requirements under the FDA Amendments Act of 2007 related
to clinical trials, pediatric drugs and devices, postmarket study
commitments, and the labeling and safe use of drugs. FDA will also
establish unique device identifiers to track devices, facilitate device
recalls, and support inventory management during disasters and the
response to terrorism events. Finally, FDA will conduct more import
exams and foreign and domestic inspections of medical product
Modernizing FDA Science and Workforce (+$50 million)
budget amendment also proposes increases to strengthen FDA’s capacity
to support product safety and development in areas of emerging science
such as nanotechnology, cell and gene therapies, robotics, genomics,
advanced manufacturing, and the critical path initiative. FDA will also
improve laboratories and other facilities that are essential to
carrying out FDA’s mission and invest in science training, professional
development, and fellowship programs to strengthen and modernize the
The program increases listed above include $65 million to modernize FDA’s information technology infrastructure.
Additional information is available online at: www.importsafety.gov; www.fda.gov; and http://www.fda.gov/oc/initiatives/advance/food.html.