The legislators also are concerned about the expanding influence of user fees on FDA operations, as seen in their rejection of the DTC prereview program. For the most part, though, members of Congress find it too easy to tap this ready revenue source to support FDA programs. In fact, 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 authorize new import fees because FDA's field operations are in shambles due to chronic underfunding and obsolete IT systems. 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 in order to streamline these underfunded operations. But Congressional leaders objected and added a ban on any field office closures to the appropriations bill.

House Energy and Commerce Committee chairman John Dingell (D-MI) proposed legislation authorizing user fees on food and drug imports to bolster inspections and field labs. The Senate Finance Committee wants to tackle import safety this year, and Senate Health Committee Chairman Ted Kennedy (D-MA) is working on a comprehensive food safety bill.

The resulting legislation is likely to give FDA more authority to halt unsafe imports, mandate product recalls, and impose penalties for illegal activities. It also could authorize FDA to establish regulatory offices in China and India to manage their fast-rising volume of drug exports to the United States. FDA signed a memoranda of agreement (MOA) with China in December that encourages safety certification of exported drugs and information sharing related to inspections, focusing initially on "designated" high-risk products subject to counterfeiting and safety issues, such as insulin, human growth hormone, and certain popular medications.

A main thrust of reformers is to require foreign manufacturers and importers to certify product compliance with quality standards as part of a lifecycle approach to import regulation. The aim is to reduce reliance on border controls and use electronic systems to identify high-risk products and track them through the supply chain.

It remains to be seen if FDA will gain the resources needed to really modernize its regulatory operations and replace outdated IT systems. The White House could regard the outcry over lax food and drug safety programs as a rationale for boosting FDA funding. But the more likely scenario is for policymakers to instruct FDA to do more with the limited resources it already has.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at jwechsler@advanstar.com