Fact Sheet on Investing in FDA'S Transformation

Steps FDA is taking to Enhance Safety, Identify Potential Harm and Respond Rapidly When Dangers Emerge

The Department of Health and Human Services’ Food and Drug Administration (FDA) is transforming itself to meet the regulatory challenges posed by a rapidly evolving global market for food, medical products, dietary supplements and cosmetics. Past regulatory approaches are no longer sufficient to meet the new challenges, especially those beyond our borders.

Recognizing this reality, FDA has taken a number of steps to bolster import product safety, protect the domestic food supply and ensure the continued safety and effectiveness of medical products. Taken together, these activities demonstrate FDA’s expanding ability to enhance consumer protections by helping to build safety into products from the beginning, intervening through targeted risk-based inspections and responding rapidly when dangers emerge.

To support FDA’s transformation plans, the Bush Administration is amending its budget request for fiscal year 2009 to include an additional $275 million. 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. 

TRANSFORMING IMPORT PRODUCT SAFETY

Recent Accomplishments

Enhance consumer protections

• Issued a Federal Register notice for a food and feed third-party certification program. The notice seeks public comment on the existence and use of accredited, impartial experts outside of FDA who could certify that food and feed products are safe, secure, and meet FDA requirements.  FDA does not have the authority to require third-party inspection, but can utilize voluntary third party certification to help prioritize facility inspections, better target high-risk imports, and facilitate the entry of safe imports.
• Received full approval for a new FDA office in China and hired a director to head the office.
• Received State Department approval to establish a new FDA office in India. 

Intervene when potential risks are identified

• Developed a test to assess the stability of two bioterrorism agents in high-risk foods, which can be used to assess other chemicals that may be used by terrorists to contaminate the food supply.

• Tested a prototype screening system that can identify food safety threats at the U.S. border. Under contract with FDA, New Mexico State University developed a prototype system for improving electronic screening of imported products offered for entry into the United States.

The prototype system, PREDICT (Predictive Risk-Based Evaluation of Dynamic Import Compliance Targeting) is currently being evaluated. 

Respond rapidly when dangers emerge

• Investigated the risk of food-borne illness from Salmonella in certain Honduran cantaloupes and issued an import alert on entry into the United States of suspect cantaloupes. Provided assistance to the company in identifying possible areas of concern and corrective strategies.
• Responded quickly to heparin problems, including identifying dangerous contaminant, notifying manufacturers and counseling on recall strategies, working with international partners to identify products containing contaminant and preventing the products from reaching the United States.

Advance prevention, intervention and response

• Signed and began implementation of two memoranda of agreement with Chinese counterpart agencies that help companies to ensure the safety of food and feed products and the safety and effectiveness of medical products exported to the United States by building quality into the process from the start.  Chinese companies that manufacture certain products intended for export to the United States will be required to register with Chinese counterpart agencies.  Plans are also under way for these agencies to create programs to certify that Chinese manufacturers and the products that they export to the United States comply with U.S. safety and manufacturing quality standards.  FDA can use this information to make better informed and more risk-based entry decisions on the products when they are presented for import at U.S. ports of entry.
• Led Security and Prosperity Partnership of North America Health Working Group with Canada and Mexico to coordinate and exchange information on food safety investigations and follow-up activities.
• Discussed import safety with counterparts from Australia, New Zealand, the European Union, India, Vietnam and several other countries.  These discussions will help developing regulatory authorities build their capacity to better regulate products, support new bilateral arrangements, and further expand FDA’s foreign presence.

Future Activities

Enhance consumer protections

• Establish additional FDA permanent foreign offices over the next two years (such as in Central America, Middle East, Europe).
• Issue draft guidance on the standards third-party certification programs should meet to be eligible for recognition by FDA.

Intervene when potential risks are identified

• Issue draft guidance providing private labs with incentives to become accredited to test imported products, expediting the entry of safe products.
• Develop a variety of new detection methods including tests that can identify melamine and cyanuric acid in various feeds and feed ingredients; antibiotics of concern in distiller’s grains; and prohibited proteins in animal feeds to support FDA’s feed ban regulations.
• Build capacity to expand the PREDICT electronic screening system as appropriate.

 Respond rapidly when dangers emerge

• Issue a proposed rule that will require marking violative products with the words “Refused Entry into the United States.

TRANSFORMING DOMESTIC FOOD SAFETY

Recent Accomplishments

Enhance consumer protections

• Issued Final Fresh-Cut Produce Guidance to industry to limit contamination of fresh-cut fruits and vegetables.
• Based on recent concerns about inadequate processing of Low Acid Canned Foods, conducted preventive field surveillance and inspections, and took action against facilities deviating from required standards.

Future Activities:

Enhance consumer protections

• Complete a final rule that will provide better information to the agency about companies that are importing food into the United States.
• Complete a final rule to reduce the risk of Salmonella contamination of shell eggs.

Intervene when potential risks are identified

• Hire and train 150 new full time equivalent staff in the Foods Field Program. This increase will aid significantly in the execution of many additional field exams.
• Conduct 1,000 additional inspections of domestic food and feed facilities in the next 12 months.
• Design a comprehensive strategy for monitoring veterinary drug residues in milk. 

Respond rapidly when dangers emerge

• Explore a system for trace back from product consumption to production.
• Issue a request for applications for funding to establish state rapid response teams to investigate foodborne illness outbreaks, perform trace backs of implicated foods and evaluate data from investigations to identify trends. Six states will be awarded cooperative agreements in the 2008 fiscal year; an additional three states will be awarded funding in fiscal 2009.
• Continue work on a pilot project to make better use of what is being reported on consumer blogs during a recall. This would enable FDA to use multiple and targeted channels to quickly alert consumers of a threat to food safety.
• Enhance interoperable information technology systems between FDA and federal, state and local testing labs.

TRANSFORMING DOMESTIC MEDICAL PRODUCTS SAFETY

Recent Accomplishments

Enhance consumer protections

• Issued a new blood donor eligibility proposed rule enhancing blood safety through strengthened donor screening and testing.
• Issued a proposed rule to change the labeling of prescription drugs to better communicate the effects of medications on pregnant and lactating women.
• Implemented electronic registration and listing for all device manufacturers, thereby providing more accurate and current information for devices in commercial distribution within the United States.
• Created new groups to monitor medical devices throughout their total product lifecycle. Each group in this new medical device matrix is product line specific and includes premarket reviewers, technical and scientific experts, compliance and regulatory experts, inspectors, and risk communicators.

Intervene when potential risks are identified

• Negotiated a plan for leveraging inspectional resources of the European Union so that the European Medicines Agency (EMEA) and the FDA will pilot joint inspections of pharmaceutical manufacturers in the United States and the European Union, and of active pharmaceutical ingredient manufacturers in third countries. The EMEA and the FDA will also exchange inspection schedules, results and other information for more inspection coverage and to better identify active pharmaceutical manufacturers in third countries.
• Announced the Sentinel Initiative, a new national, integrated electronic system for monitoring medical product safety. It will enable FDA to query multiple existing data sources, such as electronic health record systems and medical claims databases, for information about medical products.

Future Activities

Enhance consumer protections

• Develop and evaluate improved tests for influenza vaccine quality and potency that will help make vaccine available more quickly.
• Implement safety requirements of the FDA Amendments Act related to pediatric drugs and devices, such as advisory committee review of safety-related events for pediatric products, and postmarket safety commitments that include ongoing implementation of risk evaluation and minimization plans for appropriate products.
• Build a regulated product information data warehouse for receiving, storing, accessing, and analyzing standardized, structured data submitted to FDA by the sponsors of drugs, biologics, and medical devices.  This will allow FDA to make science-based decisions related to product approval and post-approval safety more efficiently.
• Finalize and adopt nationally or internationally recognized standards for drug supply chain security.

Intervene when potential risks are identified

• Enhance vaccine surveillance activities to include new managed care networks.

Respond rapidly when dangers emerge

• Expand and improve communication efforts about the benefits and risks of medical products through the recently established Risk Communication Advisory Committee. Approaches include using risk communication experts to help refine and structure FDA messaging.

SEEKING NEW LEGISLATIVE AUTHORITIES

In addition to increased resources, the administration has asked Congress to expand the FDA's authorities in the following 15 areas. These requests are still pending in Congress.

IMPORT PRODUCT SAFETY

Enhance consumer protections

• Accredit independent third parties for voluntary food inspections.
• Require certification of designated high-risk products as an additional condition of importation.
• Refuse admission of imports if firm unduly delayed, limited, or denied access to their facilities.
• Forfeiture of certain assets for certain criminal offenses.
• Authority to destroy medical products refused admission into the United States.
• Explicit extraterritorial jurisdiction.

DOMESTIC FOOD SAFETY 

Enhance consumer protections

• Require preventive controls to prevent intentional adulteration by terrorists or criminals at points of high vulnerability in the food chain.
• Issue additional preventive controls for high-risk foods.
• Require food facilities to renew their FDA registrations every two years, and allow FDA to modify the registration categories.

Intervene when potential risks are identified

• Require new reinspection fee from facilities that fail to meet current good manufacturing practices.
• Require new food and animal feed export certification fee to improve the ability of U.S. companies to export their products.

Respond rapidly when dangers emerge

• Empower FDA to issue a mandatory recall of food products when voluntary recalls are not effective.
• Give FDA expedited access to food records during emergencies.
• Asset forfeiture for criminal offenses.

DOMESTIC MEDICAL PRODUCTS SAFETY 

Enhance consumer protections

• Allow implementation of a user fee for reviewing Direct to Consumer advertising. (Proposed in the administration’s fiscal 2009 budget submission).

Intervene when potential risks are identified

• Require new reinspection fee from facilities that fail to meet current good manufacturing practices.

Respond rapidly when dangers emerge

• Forfeiture of certain assets for certain criminal offenses.