FDA at a Crossroads - Pharmaceutical Technology

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FDA at a Crossroads
Will more resources and new leadership fix FDA, or is a major overhaul in order?


Pharmaceutical Technology
Volume 33, Issue 1, pp. 32-40

Fixing the field

Another priority for a new commissioner is to revive FDA's depleted field-inspection force so that it can deal with the rise in food and drug imports and prevent unsafe products from reaching the public. The Office of Regulatory Affairs (ORA), which inspects food and drug manufacturing facilities, is in disarray after years of neglect and underfunding. Most of its top officials have retired or moved to other jobs, leaving the organization without the leadership necessary for making significant operational changes. ORA tried to close outdated field laboratories a few years ago, but met stiff opposition from laboratory employees and their political allies. A slight rise in appropriated funds has provided FDA with resources to hire more field inspectors, but a broader ORA overhaul is on the table.

In May 2008, the FDA Science Board issued an assessment of ORA that described problems generated by globalization, technical advances, and inadequate IT. 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 the heightened complexity of supply chains, moreover, have increased the potential for counterfeiting and terrorism. The number of drug products manufactured outside the US has doubled since 2001, but FDA's foreign inspections have declined by 37%. Most active pharmaceutical ingredients are imported from abroad, and a growing proportion of clinical trials are conducted in other countries. The heparin incident "brought home the need for vigilance throughout the supply chain" and highlighted the importance of manufacturing controls.

FDA's field force operates on a 70-year-old model that relies on a cadre of generalists to inspect a vast range of operations, from vegetable growers to stent makers and antibiotic producers. With the emergence of complex production methods for biologics, FDA established the small, elite Team Biologics, which has the appropriate expertise to inspect manufacturing sites for those medicines. CDER has sought to replicate that model by developing a highly trained Pharmaceutical Inspectorate to evaluate small-molecule drug manufacturers. That initiative has been slow to develop, though, and its members still have to inspect other products to meet agency needs.

The surge in food and drug contamination incidents in the past two years has generated support for FDA's Beyond our Borders initiative; it is establishing FDA branches overseas to better monitor the growing number of foreign manufacturers of products destined for the US. The agency opened offices in China in November 2008 and plans additional outposts in India, Europe, Latin America, and the Middle East to better track political and economic developments and be on the spot if problems arise (see Cover Story).

But even with more resources and foreign offices, FDA will never be able to inspect every manufacturer on a timely basis. The Science Board suggested that other approaches could 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 FDA. Any improvement in field operations, moreover, will require significant investment in new interoperable information systems for ORA.

Upgrading IT

For an agency that deals with cutting-edge biomedical science, FDA's lack of basic electronic information storage and communication systems is remarkable. 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 vast 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 all FDA operations. Information from large health-system databases could uncover signals of adverse events more quickly and effectively than is now possible. And access to clinical-trial data about marketed products could assist reviewers and monitors in evaluating new safety and efficacy problems.

The latest prescription-drug user-fee program, PDUFA IV, has mapped out a plan for establishing an all-electronic submission platform for drugs and biologics based on format and data standards. An e-submission gateway is receiving thousands of postmarket adverse-event reports, and some components of the common technical document application can be filed electronically. Goals for the next five years are to establish an agency-wide eDocument room that will permit information sharing and streamline review operations. An electronic system for registering and listing all regulated products and manufacturing facilities is in the works. The need for such a basic information system was all too apparent last year when FDA failed to correctly identify for inspection the Chinese heparin producer that turned out to be a source of contaminated product.

FDA also is updating its Adverse-Event Reporting System and encouraging medical professionals to report more adverse events electronically. The agency aims to move into the modern age of medical-product safety-information tracking by tapping into electronic health information systems to better detect signals of problems.

These initiatives will require FDA to award some $2.5 billion in contracts for IT and data-management services during the next 10 years. The agency has identified 10 contractors that will shift all systems applications to two new data centers. Ensuring that new information systems fit FDA's unique and complex operations and legal structure will require skilled oversight and informed interaction with the vendors, another challenge for a new commissioner and FDA's chief information office and staff.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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