Click here for those England's testimony: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.England-testimony.pdf
After discussing the foreseeability that a heparin type contamination situation could slip thru the FDA’s system, he made nine proposals for improved use of technology. They were:
1. “IT improvements recommended in the ISP are a contingency for executing any serious risk-targeting strategies for foreign inspections and import interdiction of unsafe drugs. This investment, however, cannot be targeted solely at drugs and devices, for the same operational systems must manage the other 90% of imported shipments and the inspection of other products. The IT fix must either be across all Centers and ORA or it must occur at the Department level to leave open the option of breaking food regulation out of FDA and combining it with other food regulators into a Food Safety Administration as a sister to the remaining Drug & Device Agency.”
2. “I continue to believe fixing FDA’s import and foreign inspection problem requires it be broken free from the domestic programs, which produce much of the bureaucratic inertia against change in this area. A new organization would enable proper staffing, allocation of human resources at ports of entry, management and implementation of ISP-based strategies. It should be responsible for all import and international focused work-planning activities; conducting facility inspections of foreign processors and importers; overseeing and conducting border operations; conducting foreign government and industry assessments and training; and support trade negotiations in a manner to enhance safety of imported products. To accomplish this, the new organization should be directly funded, rather than receiving its funding through the product Centers. A basic persistent infrastructure to manage risks associated with all imported commodities must be maintained regardless of year-to-year changes that may appropriately occur in program directions”.
3. “Section 302(b) of the Bioterrorism Act, which enables FDA to implement risk-based strategies for managing food imports, should be expanded to cover all other FDA- regulated products including drugs. This would clarify FDA’s authority to facilitate the importation of drugs that are in compliance with FDA requirements and pave the way for distinguishing between and among shipments based upon verifiable risk data”.
4. “ FDA should be required to inspect foreign drug facilities (at least those that fallinto categories FDA admits should be inspected on a regular basis) at the same frequency as domestic facilities.”
5. “FDA should work with Customs to adopt a uniform numerical identification system to begin the process of regulating its industries using an account-based system. This would enable FDA to integrate its numerous and disparate background data systems and to interrelate the data it receives from Customs and other government agencies”
6. “ FDA should publish and begin implementing the ISP in accordance with the plan’s guiding principles, goals, and themes.”
7. “FDA should begin developing programs for obtaining as much information as can be obtained from as many reliable sources as the agency can find regarding the cGMP compliance status and supply chain security programs of foreign drug facilities that are not inspected by FDA. This population of drug manufacturers will always exist, and simply saying it represents too many companies for oversight or too much data to digest is no answer at all.
Additional risk data could come in the form of third party inspection and certification companies, accompanied by a robust auditing process on both sides of the border, by foreign inspectorates, or by other U.S. Government Agency inspections and information. All such data should be connected to the firm’s unique identifier and incorporated into the account data to permit its assessment in light of other legacy and other agency data. I continue to hold to the view that obtaining and assessing all available risk data better enables FDA to (a) target its foreign and domestic inspections; (b) interdict and examine high-risk imported drug shipments (related to product safety); (c) follow up in the domestic market those shipments that proceeded through the border with inadequate inspections; and (d) facilitate imported drug shipments that are likely to have been manufactured in accordance with FDA’s cGMP requirements. This would permit the agency to focus its most earnest import inspection and examination efforts on shipments representing known and unknown risks.”
8. “FDA requires additional resources to conduct more foreign inspections and import examinations and to develop and publish meaningful Agency guidance relating to identifying and managing risks in the full life cycle of imported products.”
9. “FDA should rely on Customs and Border Protection and the Department of Homeland Security (DHS) to manage security risks associated with FDA regulated imports. DHS’ security programs should be expanded to incorporate product security risks (such as product counterfeiting and tampering) rather than focusing solely upon the security of in-transit cargo or inbound containers. “
Attorney Gordon Johnson
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©Attorney Gordon S. Johnson, Jr. 2008