Funds will support framework to enhance import safety presented last year

HHS Secretary Leavitt today 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.

Today’s 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.

“Last 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 Leavitt said.

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:

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 percent 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.
“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.

FDA will 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 manufacturers.

Modernizing FDA Science and Workforce (+$50 million)

The 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 FDA workforce.

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.

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Collaborative effort by FDA and EMEA expected to yield additional safety data
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

The new biomarkers are KIM-1, Albumin, Total Protein, β2-microglobulin, Cystatin C, Clusterin, and Trefoil Factor-3. For decades, both FDA and EMEA have required drug companies to submit the results of two blood tests, called blood urea nitrogen (BUN) and serum creatinine, to evaluate renal toxicity. In addition to those tests, the FDA and EMEA will now consider results from the seven new tests as part of their respective drug review processes. Although a decision by the sponsor to collect information using the new tests is voluntary, if collected, it must be submitted to FDA.

"The development of these and other biomarkers can result in important tools for better understanding the safety profile of new drugs," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "We hope these biomarkers will lead to human tests that detect drug-induced kidney injury in people earlier than is now possible, and help health care professionals better manage potential kidney damage from drugs."

Woodcock added that such human tests could one day open the door to the approval of more powerful drugs, especially for diseases where renal toxicity currently prevents promising experimental drugs from being approved. With more sensitive tests for renal toxicity, FDA could approve such drugs because health care professionals could closely monitor patients and halt the drug if early signs of renal toxicity appear.

Development of the new biomarkers was led by the Predictive Safety Testing Consortium (PSTC), whose members include scientists from 16 pharmaceutical companies. The PSTC was organized and led by the Critical Path Institute, a nonprofit organization that works to support FDA research collaborations that improve the development of medical products.

Researchers from Merck & Co., Whitehouse Station, N.J., and Novartis AG, Basel, Switzerland, identified the new biomarkers, tested them to prove their accuracy and usefulness, and then shared their findings with the other consortium members for further study. The consortium then submitted applications for use of the biomarkers to FDA and EMEA.

The project is the first in which a group of drug companies has worked together to propose and qualify new safety tests and then present them jointly to the FDA and EMEA for consideration. The FDA and EMEA laid the groundwork for these specific joint-agency biomarker reviews in 2004 when they developed a framework called the Voluntary Exploratory Data Submission review process.

The new process allowed the PSTC to submit a single biomarker data application to both regulatory agencies, and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators. Each regulatory agency then reviewed the application separately and made independent decisions on use of the new biomarkers.

FDA scientists believe that the seven new tests may provide important advantages over the BUN and creatinine tests. For example, in experiments using rats, the two traditional tests can only detect kidney damage a week after it has begun to occur. The new tests, however, are more sensitive and can detect cellular damage within hours. And while BUN and serum creatinine show that damage has occurred somewhere in the kidneys, the new tests can pinpoint which parts of the kidney have been affected.

The seven new tests were developed and will be carried out initially in rats. These tests were selected because other studies have shown that identical biomarkers are produced in human kidney cells. While the FDA and EMEA will consider these biomarkers in rat studies initially, the PSTC has begun work to further qualify the biomarkers for use in human studies. If successful, the PSTC will present a new biomarker data application to the two agencies to seek acceptance of the human biomarkers.

Link to the Predictive Safety Testing Consortium:
http://c-path.org/PredictiveSafe ... id/219/Default.aspx

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