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
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
Meanwhile, scandals over contaminated food and medical products from abroad have rocked the agency. In the past year, FDA
has had to contend with melamine-contaminated pet food and tainted toothpaste from China, along with fears about lethal cold
medicines containing diethylene glycol. These crises prompted hearings on Capitol Hill about food oversight and foreign drug
manufacturing inspections. A Bush administration task force unveiled a report in November offering a rehash of strategies
for improving the US food and drug import system.
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
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at email@example.com