Revised Discussion Draft of FDA Globalization Act Further Tightens the Supply Chain

Washington DC (July 24)-The House Committee on Energy and Commerce issued a revised discussion draft to the Food and Drug Administration Globalization Act of 2008. The revised draft provides additional requirements and measures to the original discussion draft that was issued in April 2008. The revised draft adds provisions for quality risk-management plans, extends annual registration requirements to excipient producers, permits US Food and Drug Administration to inspect facilities every four years rather than every two years under certain conditions, and requires electronic statements for the chain of supply of a drug.

Quality risk-management plans
Under the proposal, registered establishments that manufacture, prepare, propagate, compound, or process a drug are required to implement a quality risk-management plan that is designed to ensure the safety and quality of each drug, including any ingredients produced, manufactured, processed, packed, or held. The quality risk-management plan would include measures for risk assessment, risk control, risk communication, and risk review. The risk assessment would require pharmaceutical manufacturers to conduct audits, material evaluations, or qualification of suppliers of raw materials and other pharmaceutical ingredients before contracting with suppliers.

The quality risk-management plan would also require pharmaceutical manufacturers and their suppliers to specify the responsibilities and communication processes for manufacturing, quality control, and quality assurance. The plan would further require the following:

• Monitoring and review through periodic on-site audits of facility conditions, controls, and practices of pharmaceutical manufacturers and their suppliers

• Monitoring of incoming materials

• Implementation of effective systems, including appropriate specifications and test methods and verification of a drug ingredient’s identity, quality, strength, and purity.

The Department of Health and Human Services (HHS) would also be allowed to review a company’s quality risk-management plan during a facility inspection.

Registration requirements and fees
The revised draft requires establishments that manufacture, prepare, propagate, compound or process active pharmaceutical ingredients, excipients, or drugs to register with HHS. As in the original discussion draft, drug establishments would be required to pay annual registration fees to defray the cost of inspections. The proposal, however, exempts repackagers or excipient producers from annual registration fees. The HHS Secretary would also have the authority to waive or reduce annual registration fees in the interest of public health, to remove a barrier to innovation, or for small businesses.

The revised draft specifies that the amount of the registration fees would be based on the number of facilities, cost of facility inspections, appropriations base, rate of inspection, the percentage of information-technology cost for inspections, and the ratio of new resources to appropriated dollars.

Inspection process
As in the original draft, the revised draft specifies that FDA be required to inspect facilities every two years. The revised draft, however would allow FDA to inspect a facility every four years if the agency determines that sufficient information (e.g., type of product produced, inspection and compliance histories) exists to assess risk and establish a risk-based inspection schedule. The revised draft also calls for HHS to establish information-systems capacity sufficient to assess risk and to develop and maintain a risk-based system for conducting surveillance of current good manufacturing practices. HHS would be required to have the capacity and risk-based system in place no later than three years after the enactment of the act.

Further supply-chain requirements
The revised draft requires registered establishments to provide HHS with an electronic statement that documents the chain of supply for a drug. These requirements would include the prior sale, purchase, and trade of a drug, including the prior sale, purchase, or trade of its ingredients and raw materials.