After Heparin: - The Pew Charitable Trusts

BARRIERS TO FDA OVERSIGHT
B. Ensure adequate FDA resources
1. Consider new industry fees to support increased foreign inspections. Manufacturer registration
fees would represent a significant income source that the FDA could use to increase the
number of inspections it conducts overseas; to support ongoing improvements of systems the
agency uses to target inspections; and to track foreign manufacturing sites.
2. Consider an importer fee. Assessing a fee on importers would provide further funding for border
oversight operations. An importer fee should not be required of manufacturers that import
products if they are already assessed a fee when they register with the FDA.
3. Ensure that other appropriations also increase. The FDA has estimated that in fiscal year 2009
the cost of a foreign inspection was between $60,000 and $62,500. 452 To avoid exclusive reliance
on industry fees to support expansion of the FDA inspections, increased public appropriations
will also be necessary.
C. Improve FDA infrastructure and tracking systems
1. Fix tracking systems for manufacturing sites. Current tracking systems for manufacturing sites
contain duplicates and errors, and must be overhauled to ensure accuracy and interoperability.
The FDA must more diligently verify manufacturer registrations to ensure that information is
current and correct. Updated systems should also be able to easily interface with each other and
with risk-assessment systems to guide oversight and inspections.
2. Establish a unique facility identifier for manufacturers, importers and brokers. Manufacturers,
importers and brokers should be required to submit this unique number to the FDA at
various points, such as site registration and importation. This will help with accurate facility
identification and will help prevent mistakes due to data errors and duplicate entries. One option
for a unique facility identifier is D-U-N-S (Data Universal Numbering System)—a widely used
system for identifying business entities.
D. Strengthen oversight of drugs and bulk drug substances at import
1. Ensure that robust risk-assessment systems are used to guide border screening. The FDA
is implementing a risk-assessment system called PREDICT to assess imported food, devices and
drugs.
2. Give the FDA authority to destroy products at the border. The FDA is currently authorized
to refuse drug products at the border that appear to be adulterated or misbranded, but statutory
remedies include reexportation of these potentially violative products. 453 This may allow harmful
drugs to reenter the United States. The FDA should have the power to destroy drugs and drug
products that it determines could pose a threat of injury or death.
After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 59