FDA Globalization Act Introduced in House

H.R. 759 Reflects Input Received from 2008 "Discussion Draft"

In 2008, the House Energy and Commerce Committee held a series of hearings on a "discussion draft" entitled Food and Drug Administration Globalization Act of 2008. Congressional sources indicate that H.R. 759 reflects input received from key stakeholders."

Highlights of FDA Globalization Act

According to the sponsor's summary of the bill, H.R. 759 would:

General Provisions

Importer registry - require all importers of drugs, devices, foods, and cosmetics to register with the FDA annually and pay a registration fee.

Facility, importer IDs - create unique identification numbers for all drug, device, food, and cosmetic facilities and importers (to improve the accuracy of data and the ability of FDA to more quickly identify involved parties in a crisis situation).

Foreign facility monitoring - increase the capacity of FDA to monitor foreign facilities producing food, drugs, devices, and cosmetics for U.S. consumers.

Field sites - prohibits FDA from closing or consolidating field laboratories or district offices.

False, misleading reporting - extend the current prohibition against making false or misleading reports related to devices to include food, drugs, and cosmetics.

Whistleblower protection - prohibit 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.

Food Safety

Registry of food facilities - require all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.

Facility registration fee - require 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.

Increased inspections - require FDA to establish a risk-based schedule for inspecting foreign and domestic food facilities. Set 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 U.S.

Foreign food manufacturer certification - require foreign food manufacturers to be certified as meeting all U.S. food safety requirements by third parties accredited by FDA. Uncertified facilities would be prohibited from exporting to the U.S.

Importer expedited processing - direct FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.

Fresh produce safety plans - direct FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.

Facility food safety plans - require 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.

Country-of-origin labeling - require all processed food labels to indicate the country in which final processing occurred. Require food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for all produce.

FDA accredited lab testing - require any testing done to meet certain safety requirements to be performed only by a laboratory accredited by the FDA and require laboratories to send any test results to FDA.

Mandatory recalls, strengthened fines - provide FDA new authority to issue mandatory recalls of tainted foods and strengthen fines imposed on food facilities that fail to comply with safety requirements.

Foods treated with carbon monoxide - require 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.

Export certificate fees - allow FDA to charge a fee to domestic firms requiring export certificates.

Improved traceability - expand 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. Under H.R. 759, farms and restaurants, which are exempted under current law, would be included in the traceback requirement.

H.R. 759 would also (i) mandate 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); and (ii) require a standardized lot number for each shipment to ensure the number for the same shipment is consistent throughout the supply chain.

Food safety science - direct the Secretary of Health and Human Services (Secretary) to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary would also be directed to identify industry and regulatory approaches to minimize hazards in the food supply.

Public GRAS determinations - require publication of the request for a "generally recognized as safe" (GRAS) decision and FDA's determination.

Drug and Device Safety

Drug/device facility registry - require all domestic drug and device facilities and foreign facilities exporting to the U.S. to register with FDA annually and pay a registration fee. Registration fees would fund increased inspections by FDA and to improve information systems. Funding would supplement, not supplant existing appropriations. Failure to register or pay the fee would be a cause for denying entry of the facility's product into the U.S.

New enforcement tools:

Destruction - allow FDA to destroy counterfeit or adulterated imports if they pose a risk of injury or death.

Civil monetary penalties - create 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 - increase 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 - give FDA new authority to mandate recalls of unsafe drugs.

Administrative detention - give FDA new authority to detain unsafe drug discovered during the course of an inspection.

Subpoena - give FDA new authority to subpoena records related to possible violations

Foreign/domestic inspection parity - require 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.

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Non-cooperation with inspections - deny entry to drugs coming from facilities that limit, delay or deny FDA inspections.

Importer safety demonstration - require drug importers to affirmatively demonstrate their products come from registered facilities and meet all requirements related to safety and quality.

Manufacturer supply chain documentation - require 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.

Risk identification, mitigation - require finished dose and active ingredient manufacturers to have in place written plans to identify and control risks specific to the drug being produced. Require manufacturers to conduct on-site audits of ingredient and raw material suppliers. Require manufacturers to test for likely contaminants.

Country of origin ID - require drug manufacturers to list on their Web site the country of origin for all drug ingredients and for the finished product.

Pre-approval inspection funding - require generic drug manufacturers to pay a fee to cover the cost of drug pre-approval inspections.

Pre-approval inspection increase - require that preapproval inspections 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 good manufacturing practices (GMPs), verify the data in the application or otherwise ensure the safety of the product.

Cosmetic Safety

Cosmetic facility registry - require all facilities operating within the U.S. or exporting cosmetics to the U.S. to register with the FDA annually.

Adverse event reporting - require all cosmetic facilities operating within the U.S. or exporting cosmetics to the U.S. to report adverse events resulting from the use of their products to FDA.

GMP compliance - require all cosmetic facilities operating within the U.S. or exporting cosmetics to the U.S. to comply with GMPs established by the Secretary.

(See ITT's Online Archives or 04/28/09 news, 08042810, for BP summary on the announcement of hearings on the 2008 "discussion draft.")

H.R. 759 available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h759ih.txt.pdf.

Summary of H.R. 759 available by emailing documents@brokerpower.com.

Press release on introduction of H.R. 759 available at http://www.house.gov/apps/list/press/mi15_dingell/090128FDA.shtml.