Summary of the Food and Drug Administration
                    Globalization Act of 2009
Food Safety

  1) Creates an up-...
•   Mandates a standardized electronic record to ensure fast and efficient
       traceback. Current law only requires ent...
2) Generates funding for increased GMP inspections for brand and
       generic drugs: Registration fees would fund increa...
9) Requires manufacturers to identify and mitigate risk throughout their
     supply chain: Requires finished dose and act...
1) Creates an up-to-date registry of importers: Requires all importers of
   drugs, devices, foods, and cosmetics to regis...
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FDA Globalization Act (Dingell Bill) Summary Jan 2009

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FDA Globalization Act (Dingell Bill) Summary Jan 2009

  1. 1. Summary of the Food and Drug Administration Globalization Act of 2009 Food Safety 1) Creates an up-to-date registry of all food facilities serving American consumers: Requires all facilities operating within the US or importing food to the US to register with the FDA annually. 2) Generates resources to support FDA oversight of food safety: Requires payment of a registration fee per facility that would generate revenue for food safety activities at the FDA. The registration fee would be waived for small businesses and facilities that solely serve as warehouses. 3) Prevents food safety problems before they occur: Requires foreign and domestic food facilities to have safety plans in place to identify and mitigate hazards. Safety plans would be subject to review by FDA inspectors and third-party certifiers. 4) Increases inspections: Requires FDA to establish a risk-based schedule for inspecting foreign and domestic food facilities. Sets a minimum inspection frequency of once every four years. Refusing, impeding or delaying an inspection would be cause for suspension of registration and for barring entry into the US. 5) Requires food imports to demonstrate safety: Requires foreign food manufacturers to be certified as meeting all US food safety requirements by third parties accredited by FDA. Uncertified facilities would be prohibited from exporting to the US. 6) Creates fast-track import process for food meeting security standards: Directs FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing. 7) Requires safety plans for fresh produce: Directs FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables. 8) Improves traceability: Significantly expands FDA traceback capabilites in the event of an outbreak of foodborne illness by filling the loopholes in the current requirements in the Bioterrorism Act of 2002: • Includes farms and restaurants in the traceback requirement. Under current law, these two entities were exempted.
  2. 2. • Mandates a standardized electronic record to ensure fast and efficient traceback. Current law only requires entities to hold a record in any form - paper or electronic. • Requires a standardized lot number for each shipment to ensure the number for the same shipment is consistent throughout the supply chain. 9) Requires country-of-origin labeling and disclosure: Requires all processed food labels to indicate the country in which final processing occurred. Requires food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for all produce. 10) Expands laboratory testing capacity: Requires any testing done to meet certain safety requirements to be performed only by a laboratory accredited by the FDA. Requires laboratories to send any test results to FDA. 11) Provides strong, flexible enforcement tools: Provide FDA new authority to issue mandatory recalls of tainted foods. Strengthens fines imposed on food facilities that fail to comply with safety requirements. 12) Clarifies consumer labeling for certain foods treated with carbon monoxide: Requires meat, poultry and seafood products to which carbon monoxide has been added to be labeled with a consumer notice that the freshness of the product should not be judged by color. 13) Advances the science of food safety: Directs the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the food supply. 14) Makes GRAS determinations public: Requires publication of the request for a “generally recognized as safe” (GRAS) decision and FDA’s determination. 15) Allows FDA to charge a fee to domestic firms requiring export certificates Drug and Device Safety 1) Creates an up-to-date registry of all drug and device facilities serving American consumers: Requires all domestic drug and device facilities and foreign facilities exporting to the US to register with FDA annually and pay a registration fee.
  3. 3. 2) Generates funding for increased GMP inspections for brand and generic drugs: Registration fees would fund increased inspections by FDA and to improve information systems Funding will supplement, not supplant existing appropriations. Failure to register or pay the fee is a cause for denying entry of the facility’s product into the US. 3) Generates funding for pre-approval inspections for generic drugs: Currently generic drugs, unlike brand drugs, do not pay fees under PDUDA to support FDA activities related to drug approvals, including pre- approval inspections. The lack of resources impedes FDA’s ability to conduct the necessary inspections of this type of manufacturer, particularly since the majority are now located abroad. This legislation would require generic drug manufacturers to pay a fee to cover the cost of pre-approval inspections. 4) Increases pre-approval inspections: To address the concern that FDA is failing to conduct pre-approval inspections of foreign drug facilities with very questionable safety records, this legislation would require that pre- approval inspections to be conducted unless FDA makes a determination that, based on the inspectional history of the facility, an inspection isn’t needed to ensure compliance with GMPs, verify the data in the application or otherwise ensure the safety of the product. 5) Requires parity between foreign and domestic inspections: Requires FDA to inspect foreign and domestic drug facilities every two years. Allows FDA to modify an individual facility’s inspection schedule only if FDA determines that sufficient information exists about that facility’s inspection history and compliance record to justify less frequent inspections. . 6) Denies entry to drugs coming from facilities that limit, delay or deny FDA inspections. 7) Prohibits the entry of drugs into the US lacking documentation of safety: Rather than solely relying on FDA to determine if a drug shipment appears to be dangerous based on the limited information currently provided at the border, the legislation would require drug importers to affirmatively demonstrate their products come from registered facilities and meet all requirements related to safety and quality. 8) Requires manufacturers to know their supply chain: To aid in preventing and investigating incidents like the heparin crisis, requires manufacturers, when requested by FDA, to provide documentation of their complete supply chain, back to the raw materials, and to document measures taken to secure their supply chain.
  4. 4. 9) Requires manufacturers to identify and mitigate risk throughout their supply chain: Requires finished dose and active ingredient manufacturers to have in place written plans to identify and control risks specific to the drug being produced. Requires manufacturers to conduct on-site audits of ingredient and raw material suppliers. Requires manufacturers to test for likely contaminants. 10) Country of Origin labeling: Requires drug manufacturers to list on their website the country of origin for all drug ingredients and for the finished product. 11) Provides strong new enforcement tools: • Destruction: Allows FDA to destroy counterfeit or adulterated imports if they pose a risk of injury or death. • Civil monetary penalties: Creates new authority to impose fines for any violation of the Food, Drug and Cosmetic Act related to drugs. Significantly increases fines for repeat offenders. • Criminal penalties: Increases penalties related to counterfeit drugs to 20 years from one year. Increases the penalty up to life in prison if the use of the counterfeit product causes death. • Mandatory recall: Gives FDA new authority to mandate recalls of unsafe drugs. • Administrative detention: Gives FDA new authority to detain unsafe drug discovered during the course of an inspection. • Subpoena: Gives FDA new authority to subpoena records related to possible violations Cosmetic Safety 1) Creates an up-to-date registry of all cosmetic facilities serving American consumers: Requires all facilities operating within the US or exporting cosmetics to the US to register with the FDA annually. 2) Requires adverse event reporting: Requires all cosmetic facilities operating within the US or exporting cosmetics to the US to report adverse events resulting from the use of their products to FDA. 3) Requires compliance with GMPs: Requires all cosmetic facilities operating within the US or exporting cosmetics to the US to comply with good manufacturing practices established by the Secretary. General Provisions
  5. 5. 1) Creates an up-to-date registry of importers: Requires all importers of drugs, devices, foods, and cosmetics to register with the FDA annually and pay a registration fee. 2) Requires unique identification numbers for facilities and importers: To improve the accuracy of data and the ability of FDA to more quickly identify involved parties in a crisis situation, creates unique identification numbers for all drug, device, food, and cosmetic facilities and importers. 3) Creates a dedicated foreign inspectorate: Increases the capacity of FDA to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers. 4) Continues operation of field laboratories: Prohibits FDA from closing or consolidating field laboratories or district offices. 5) Prohibits false or misleading reporting to the FDA: Extends the current prohibition against making false or misleading reports related to devices to include food, drugs, and cosmetics. 6) Provides protection for whistleblowers that bring attention to important safety information: Prohibits entities regulated by the FDA from discriminating against an employee in retaliation for assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.

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