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Michael A. Swit, Esq.
Law Offices of Michael A. Swit
539 Samuel Ct., Suite 229
Encinitas, California 92024
760-815-4762 ♦ 760-454-2979 (fax)
mswit@fdacounsel.com
http://www.fdacounsel.com
ORANGE COUNTY REGULATORY AFFAIRS
(“OCRA”)
DISCUSSION GROUP”
March 19, 2002
Irvine, California
WORKSHOP ON IMPORTING AND EXPORTING DRUGS AND DEVICES
IMPORTS
I.
PROHIBITED IMPORTS
A.
B.
A device OR drug may be refused entry into the United States if it appears to
be:
1.
manufactured, processed, or packed under insanitary conditions or, for a
device, if does not meet QSR;
2.
forbidden or restricted from sale in the country in which it was produced
or from which it was exported; and/or
3.
adulterated, misbranded, or in violation of the new drug approval
requirements of the Federal Food, Drug, and Cosmetic Act (FDCA)
[FDCA § 801(a), 21 U.S.C. § 381(a)]
to refuse admission of an imported product, the Food and Drug
Administration (FDA)
1.
need not prove a violation of the FDCA (as would be the case in a
domestic enforcement action). In the case of imports, the product need
only "appear" to violate the law.
2.
FDA's conclusion need not be based on actual examination of the product,
since the law permits FDA to make a determination based on examination
of samples "or otherwise" [FDCA § 801(a), 21 U.S.C. 381(a)]
3.
Prescription drugs that have been manufactured in the United States, and
exported, may only be reimported by the original manufacturer, except as
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authorized by FDA if required for emergency medical care – NOTE:
amended by statute in 2000, but Secretary Shalala refused to implement
[FDCA § 801(d), 21 U.S.C. § 381(d)]
II.
IMPORTING UNAPPROVED DRUGS AND DEVICES
Notwithstanding the Restrictions Noted Above, an Unapproved New Drug May Be
Imported into the United States Under Certain Circumstances.
A.
B.
C.
New drugs and devices not yet approved that are the subject of an active
investigational new drug application ("IND") or investigational device
exemption (“IDE”) may be imported if:
1.
the consignee in the United States is the sponsor of the IND;
2.
the consignee is a qualified investigator named in the IND; and/or
3.
the consignee is the domestic agent of a foreign sponsor, is identified in
the IND, and is responsible for the control and distribution of the
investigational drug
[21 C.F.R. § 312.110(a)]
4.
for a device, the importer acts as the agent for the foreign exporter as to
investigations or must ensure someone else acts as the agent
[21 CFR § 812.18]
A drug substance intended for use in the manufacture, processing, or repacking
of an unapproved new drug may be imported if:
1.
there is a pending NDA covering the use of the drug substance in the
production and marketing of a finished drug product,
2.
the finished drug product is not distributed until the NDA is approved, and
3.
the package label states: "Caution: for manufacturing, processing, or
repacking" (and also, if a prescription drug, the statement "Caution:
Federal law prohibits dispensing without prescription")
[21 C.F.R. §§ 201.122, 314.410(a)(2)].
Personal, noncommercial, and nonpromotional shipments of unapproved drugs
may, in the exercise of FDA's discretion, be imported by mail and in the personal
baggage of persons entering the United States when:
1.
the intended use is appropriately identified, such use is not for treatment of
a serious condition, and the product is not known to represent a serious
health risk; and/or
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2.
the intended use is unapproved for a serious condition for which effective
treatment may not be available domestically either through commercial or
clinical means,
3.
there is no known promotion or commercialization to persons residing in
the United States by those involved in the distribution of the product at
issue,
4.
the product is considered not to represent an unreasonable risk,
5.
and the individual seeking to import the drug affirms in writing that it is
for the patient's own use and provides the name and address of the United
States doctor responsible for the patient's treatment with the drug or
provides evidence that the drug is for the continuation of a treatment
begun in a foreign country
[Regulatory Procedures Manual, Chapter 9]
6.
Import for export/exception
§ 801(d)(3) of FDCA
7.
III.
IV.
a.
Intent to Export Statement
b.
Maintain records that identify the use of the imported article and
make these records available to the FDA upon request.
Destroy/Re-Export unused component, part, or accessory
FOREIGN ESTABLISHMENT REGISTRATION AND U.S. AGENT
A.
New rule – Nov. 27, 2001 – applies to drugs, biologics and devices.
B.
Must have a U.S. Agent.
1.
has to be on U.S. soil and, arguably, have an office here
2.
implements Section 417 of FDAMA
C.
Must list any products in distribution.
D.
Enforcement:
1.
Devices – April 26, 2002
2.
Drugs and Biologics – May 28, 2002
HOW FDA HANDLES IMPORTS
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A.
B.
The Players:
1.
District Offices (see Attachment).
2.
Center For Drug Evaluation and Research (CDER) Office of Compliance.
3.
Commissioner's Office -- Division of Import Operation and Policy.
General Administrative Process:
Regulatory Procedures Manual, Ch. 9, Subchapter, “Import Procedures”
1.
Broker files "Entry Notice " to U.S. Customs (Secretary of Treasury).
2.
Customs forwards "Entry Notice" to FDA District Office from which
exported (delivered to the Secretary of Health and Human Services).
3.
"Entry Notice" from Customs reviewed to determine if it appears:
4.
C.
a.
Manufactured in facilities not conforming to GMP
b.
Forbidden in country from which exported.
c.
Adulterated or misbranded
May Proceed/Sampling/Notice of Detention.
Special coverage approaches for imports.
1.
Saturation sampling.
a.
Exert uniform national pressure.
2.
Sampling specific product, country of origin, manufacturers.
3.
Using previous detentions as basis of action.
4.
Intensified coverage of importers of problem products.
5.
Sample all products of importer.
6.
Automatic detention.
a.
Import Alert.—publicly-available internal document of problem
products.
e.g., all foreign-made Dial Soap
D.
Detention
1.
FDA Hearing
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a.
2.
E.
District Office
Federal District Courtt
a.
Review Administrative Record
b.
Arbitrary/Capricious/Discretionary Abuse
Post-September 11 –
1.
“Homeland Security” will have an increased emphasis on import scrutiny
(see FDA Budget for FY 2002) – e.g., the Devices Center will have its
largest increase in funding assigned to “Field” personnel working the
ports.
2.
Emphasis in particular on cyber fraud – foreign products being offered in
the U.S. via the Internet – “Cyber letters” to sites selling Cipro
3.
Mexican entry – being very closely scrutinized relative to past oversight
DRUG AND DEVICE EXPORTS
V.
ALL DRUGS AND DEVICES LAWFULLY MARKETED IN THE UNITED
STATES MAY BE EXPORTED FROM THE UNITED STATES
A drug/device that is in compliance with the requirements of FDCA such that it may be
lawfully marketed within the United States may be exported from the United States.
Exception (very limited) § 801 (e)(1) [see VII-A below]
VI.
EXPORTING UNAPPROVED DRUGS AND DEVICES
A.
B.
General Requirements - Section 801(e)(1) of the FFDCA
1.
Meet specifications of foreign purchaser;
2.
Not in conflict with laws of importing country;
3.
Shipping package labeled as intended for export; and
4.
Not sold, or offered for sale, in U.S. commerce.
Kanasco v. United States (4th Circuit Case)
Export Under 802(b)(1) – “Tier One”
1.
Meets the requirements of Section 801(e)(1) of the FFDCA
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2.
Comports with the laws of the importing country;
3.
Valid marketing authorization from a "tier one" country [= EU or
European Econ. Area countries + Australia, Canada, Israel, Japan, New
Zealand, Switzerland, S. Africa]
4.
The drug is not adulterated in the following ways:
a.
consists of any filthy, putrid, or decomposed substance;
FDCA § 501(a)(1)
b.
prepared, packed, or held under insanitary conditions that could
result in contamination by filth or injury to health; or
FDCA § 501(a)(2)(A)
c.
container is composed of any poisonous or deleterious substance
which may render the contents injurious to health; or
FDCA § 501(a)(3)
d.
strength, purity, or quality falls below that which it purports or is
represented to possess;
FDCA § 501(c)
e.
mixed or packed with any substance so as to (1) reduce its quality
or (2) substitute for it wholly or in part
FDCA § 501(d)
f.
Substantial conformance with GMPs, or meets international quality
systems standards recognized by FDA;
FDCA § 802(f)(1)
g.
Not an imminent public health hazard;
FDCA § 802(f)(4)
h.
Labeled/Promoted in accordance with requirements and conditions
of:
FDCA § 802(f)(5)(A)
(1)
tier one country granting valid marketing authorization; and
(2)
the importing country;
i.
Labeled in the language and units of measurement designated by
the importing country;
FDCA § 802(f)(5)(B)
j.
Export notification:
(1)
Listed country
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(2)
k.
C.
D.
Unlisted country
Record Maintenance:
(1)
Drugs exported
(2)
Countries to which devices exported.
Tier “Two” Countries
FDCA § 802(b)(2)
1.
Don’t have authorization from one of the “Big 25”
2.
But do:
a.
Meet the law of the destination country; and
b.
Have valid marketing authorization from responsible authority
within the destination country
Tier “Three” Countries:
FDCA § 802(b)(3)
1.
Exporter provides FDA with “credible scientific evidence” that satisfies
FDA as to the safety and effectiveness of the conditions of use in the
destination country
2.
Destination country “appropriate health authority” must:
a.
Request FDA to approve the export
b.
Certifies that it understands that the drug isn’t approved in U.S. or
“Big 25”
c.
Concur that the “credible scientific evidence” for use in its country
E.
Export under 802(c) - Drugs for Investigational Use
F.
Export under 802(d) - Anticipation of Marketing Authorization
G.
Export under 802(e) - Diagnosis, Prevention, or Treatment of Tropical Disease.
H.
1.
FDA Approved Application: Risk/Benefit Determination
2.
Reporting Requirements: Adverse Events or Diversion
Export Notification and Recordkeeping Requirements – Dec. 19, 2001 Federal
Register notice (66 Fed. Reg. 65429).
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1.
VII.
Adds new regulation – 21 CFR §1.101 -- have to keep a record of all the
devices or drugs exported under §802(b), including:
a.
records showing the product met the foreign purchaser’s specs
b.
records showing the product does not conflict with foreign
company’s specifications
c.
records showing the product was labeled on outside with a
statement that it was intended for export.
d.
Records to show the product is not offered for sale in the U.S.
e.
Extra rules for partially processed biologics
CERTIFICATES FOR EXPORT – IN COMPLIANCE
FDCA § 801(e)(4)
A.
Certificates to Foreign Government
B.
Certificate of Exportability
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Questions?
Call, e-mail, fax or write:
Michael A. Swit, Esq.
Law Offices of Michael A. Swit
539 Samuel Ct., Suite 229
Encinitas, California 92024
760-815-4762 ♦ 760-454-2979 (fax)
mswit@fdacounsel.com
http://www.fdacounsel.com
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About the speaker ...
Michael A. Swit has extensive experience in all aspects of FDA regulation with a particular emphasis on
drugs and medical device regulation. In addition to his regulatory law experience, Mr. Swit also
served for three and a half years as vice president and general counsel of Pharmaceutical Resources,
Inc. (PRI) a prominent generic drug company and, thus, brings an industry and commercial
perspective to his representation of FDA-regulated companies. While at PRI from 1990 to late
1993, Mr. Swit spearheaded the company’s defense of multiple grand jury investigations, other
federal and state proceedings, and securities litigation stemming from the acts of prior management.
Mr. Swit then served from 1994 to 1998 as CEO of Washington Business Information, Inc. (WBII)
a premier publisher of FDA regulatory newsletters and other specialty information products for the
FDA publishing company. Before starting FDACounsel.com, he was with Heller Ehrman from
May 2001 to May 2003, and also twice in private practice with McKenna & Cuneo, from 1988 to
1990 and, most recently, from 1999 to 2001, first in that firm’s D.C. office and most recently, in its
San Diego office. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius
from 1984 to 1988. Mr. Swit has taught and written on a wide variety of subjects relating to FDA
law including, since 1989, co-directing a three-day intensive course on the generic drug approval
process, serving on the Editorial Board of the Food & Drug Law Journal, and editing a guide to the
generic drug approval process, Getting Your Generic Drug Approved, published by WBII. Mr. Swit
holds an A.B., magna cum laude, with high honors in history, in 1979, from Bowdoin College, and
earned his law degree from Emory University in 1982. He is a member of the California, Virginia
and District of Columbia bars.
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