Limited Resources Challenge Regulators - The much needed modernization of the agency's IT systems and inspection capabilities will likely fall prey to budget shortfalls. - BioPharm International

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Limited Resources Challenge Regulators
The much needed modernization of the agency's IT systems and inspection capabilities will likely fall prey to budget shortfalls.


BioPharm International
Volume 21, Issue 2

A much larger influence on FDA operations is the expanding role of user fees in agency funding: almost one-fourth of FDA's $2.2-billion 2008 budget will come from user fee revenues and most of that ($460 million) from pharmaceutical and biotech manufacturers. At the December Science Board meeting, attorney Hutt lamented the funding "desperation" that has forced FDA to rely increasingly on user fees to shore up its depleted coffers.

Yet members of Congress find it too easy to tap this ready source of revenue to support FDA programs, minimizing the likelihood that the fees will be reduced or eliminated. In fact, the FDA Amendments Act (FDAAA) boosted drug user fees by another $25 million for each of the next five years to support additional drug safety initiatives, and pending legislation proposes to raise millions more through fees on food and drug imports.

INSPECTIONS AND IMPORTS

Congress is likely to enact food and drug import legislation because FDA's Office of Regulatory Affairs (ORA), which operates the agency's field inspection force, has suffered from depleted resources even more than the rest of the agency. FDA officials unveiled a major field consolidation plan two years ago that proposed to close regional offices, reduce the number of district offices from 20 to 16, and shut seven of 13 field laboratories. But Congressional leaders blocked the closures, and ORA officials agreed to "take a fresh look" at how to meet its challenges.

Meanwhile, scandals over contaminated food and medical products from abroad have focused public attention on the inadequacies of the current system for ensuring safe food and drug imports. In the past year, FDA had to contend with contaminated pet food and toothpaste from China, along with fears about tainted blood substitutes and liquid medicines laced with diethylene glycol.

These crises prompted hearings on Capitol Hill. The Bush administration established an import safety task force headed by Health and Human Services Secretary Mike Leavitt to map out improvements in the US food and drug import system, which produced a report in November. House Energy & Commerce Committee Chairman John Dingell (D-MI) proposed user fees on imported food and drug shipments to bolster US inspections and field laboratories. The Senate Finance Committee has interest in tackling import safety this year, and Senator Kennedy is working on a comprehensive food safety bill. The resulting legislation is likely to enhance FDA's authority to mandate product recalls and halt imports, boost penalties for illegal activities, and require foreign manufacturers and importers to certify product compliance with quality standards.

Reformers seek a lifecycle approach to import regulation that follows products through the supply chain and delivers assessments of product risk to border inspectors, compliance offices, and electronic screening systems. A recent proposal is for FDA to establish regulatory offices in China and India to manage the rising volume of drug exports to the US. FDA signed a memorandum of agreement with China in December that encourages safety certification of exported drugs and information sharing related to inspections. It will focus initially on designated high-risk products including insulin, blood screening diagnostics, human growth hormone, and others.

It remains to be seen if FDA will gain the resources needed to really modernize its field force, foreign inspection capability, and outdated IT systems. There is some concern that policy changes could open US borders to more counterfeit and unregulated products without a major overhaul of current policies and operations. Congress is providing some funding increase for food monitoring, but it's not clear whether that will translate into broader improvements in how the agency oversees imported drugs and biotech therapies.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,
.

REFERENCES

1. US Food and Drug Administration. FDA Science and Mission at Risk. 3 Dec 2007. Available from: http:// http://www.fda.gov/ohrms/dockets/ac/oc07.htm#ScienceBoard


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