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June 11, 2003
The Honorable Mark B. McClellan, M.D., Ph.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. McClellan:
In light of continued national security concerns and FDA's challenge in
protecting the public health, the Committee is examining the adequacy of FDA's
import controls. Specifically, this examination is focused on two areas of
interest: (1) how FDA's import controls performed during Operation Liberty
Shield (OLS) for the time period of heightened security concerns associated with
combat operations in Iraq (March 19-April 18, 2003); and (2) what steps, if any,
FDA is taking to adopt a risk-based import surveillance system to replace FDA's
current import program.
Pursuant to Rules X and XI of the U.S. House of Representatives, please
provide the following information by June 25, 2003:
1. How many imported lines of entry did FDA receive during March 19-April 18,
2003 of all FDA-regulated products?
2. How many of these imported lines of entry hit in OASIS (Operational and
Administrative System for Import Support) based upon FDA's high risk OLS
criteria or counter-terrorism targeting?
3. How many lines of entry of OLS targeted products were declared to FDA in
FY2002 and thus far in FY2003 by month?
4. How many of the OLS targeted lines of entry that hit in OASIS did FDA
actually inspect, what activities did FDA undertake during such inspections, and
at what rates were each activity conducted (e.g. OASIS on-screen review,
document review, physical examination of cargo, and if sampling for analysis,
for what analytes)?
5. What were the criteria that FDA used to decide to inspect any entries
under OLS? What was the justification for using these criteria? How were the
criteria developed and who was responsible for developing the criteria? Were
these criteria based on any risk assessment that is different from FDA's
traditional criteria setting process?
6. What was FDA's resource allocation before this time period (number of
staff, budget, e.g.) for import field activity?
7. What was FDA's resource allocation during Operation Liberty Shield for
import field activity?
8. What is FDA's resources allocation now for import field activity?
9. Section 302 of the Bioterrorism Act requires FDA to give high priority to
increasing the number of food import inspections. The Bioterrorism Act also
requires FDA to give the greatest priority to detecting intentional adulteration
of foods, and high priority to facilitating importation of foods that are in
compliance with the Food, Drug, and Cosmetic Act (FDCA). Should the requirement
of facilitation of imports in compliance with FDCA be extended to all
commodities? Do you believe such a requirement would drive industry to the FDA
in partnerships to (a) mitigate identifiable risks, (b) manage those risks in an
auditable, verifiable system, and (c) permit the FDA to focus its resources on
known risks, or unknown players in the market - thus focusing on the segments of
industry where there is likely to be intentional adulteration? Further, is a
grant of statutory authority required to facilitate importation of FDA-regulated
products other than food that are in compliance with the FDCA, or could this
objective be achieved through other means?
10. In your April 1, 2003 speech at the Food Drug Law Institute, you noted
that the "best solution will be the adoption of a risk-based import
surveillance system to replace [FDA's] current import program." What
specific steps is FDA taking to mitigate risks by shifting FDA's import
surveillance system toward a "life-cycle" approach? Has FDA
communicated with importers or foreign manufacturers about their product
security systems and how has the information about these product security
systems been used to help FDA construct a risk-based system for screening
imports? Please provide all records since January 1, 2003 relating to these
questions.
11. Who is responsible for implementing the prior notice rule? Who are the
decisionmakers regarding implementation of the Bioterrorism Act?
For the purpose of responding to this request for information and documents,
the terms "records" and "relating" should be interpreted in accordance with the
Attachment to this letter. If you have any questions, please contact Alan
Slobodin of the Committee Staff at (202) 225-2927.
Sincerely,
W.J. "Billy" Tauzin
Chairman
James C. Greenwood
Chairman, Subcommittee on Oversight and Investigations
cc: The Honorable John D. Dingell, Ranking Member
The Honorable Peter Deutsch, Ranking Member, Subcommittee on Oversight and
Investigations
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