FIXING THE FIELD

Another priority for a new commissioner is to revive the FDA's depleted field inspection force. The Office of Regulatory Affairs (ORA) is in disarray because of years of under-funding. Most of its top officials have retired or moved to other jobs, leaving the organization without the leadership needed to make necessary operational changes. District laboratories require new equipment for efficient product analysis, and scientists need infrastructure to conduct risk assessments and analysis. The explosion in global manufacturing and increased complexity of supply chains, moreover, have increased the potential for counterfeiting and terrorism. Heparin was "a wake-up call," says Woodcock. It "brought home the need for vigilance throughout the supply chain" and highlighted the importance of manufacturing controls.

The FDA's field force operates on a 70-year-old model that relies on generalists who inspect a vast range of operations, from vegetable growers to antibiotic producers. With the emergence of complex production methods for biologics, the FDA established an elite Team Biologics with expertise in biotech manufacturing to inspect those sites. CDER has sought to replicate that model by developing a highly trained pharmaceutical inspectorate to evaluate drug manufacturers.

But even with more resources and foreign offices, the FDA will never be able to inspect every manufacturer on a timely basis. Other approaches may be needed to support field operations, including certification programs for foreign manufacturers, increased reliance on inspections by foreign regulatory authorities, improved risk management of inspection programs, and more efficient technology assay procedures validated by the agency.

IMPROVING INFORMATION TECHNOLOGY

Any improvement in field operations will require significant investment in new interoperable information systems. The FDA's IT infrastructure is "obsolete, unstable, and lacks sufficient controls to ensure continuity of operations," according to the Science Board. Most agency records are on paper and stored in document rooms that are difficult to access. Research laboratories lack the computing infrastructure necessary to conduct appropriate analyses and studies. Many of the agency's network servers have exceeded their recommended service life, and the system lacks security and normal backup capability.

A reliable, modern IT system could bring considerable efficiencies to the FDA operations. Instead of sending inspectors to check manufacturing operations and product quality, cutting-edge technology could allow the agency to position remote sensing devices at plants able to detect product contamination or diversion in real time. Information from large health-system databases could uncover signals of adverse events more quickly and effectively. And access to clinical trial data on marketed products could assist reviewers and monitors in evaluating new safety and efficacy issues. The latest prescription drug user fee program, PDUFA IV, has mapped out a plan for establishing an all-electronic submission platform for drugs based on format and data standards. The FDA expects to spend approximately $2.5 billion over the next 10 years for new IT systems. Ensuring that such information systems fit the agency's complex organization and legal structure will require skilled oversight of vendors, which is another challenge for the new commissioner.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, jwechsler@advanstar.com