IA 57-21, 5/10/07, IMPORT ALERT #57-21, "IMPORT ALERT #57-21, "DETENTION
WITHOUT PHYSICAL EXAMINATION OF IMPORTED TRICHURIS SUIS OVA (TSO); PIG
WHIPWORM EGGS"
TYPE OF ALERT: Detention Without Physical Examination
NOTE: This import alert represents the Agency's current
instructions to FDA field personnel regarding the
manufacturer(s) and/or product(s) at issue. It does not
create or confer any rights for or on any person, and does
not operate to bind FDA or the public.
PRODUCT: Trichuris suis Ova (TSO); Pig Whipworm Eggs
PRODUCT CODE: 57---
PROBLEM: No U.S. License
PAC: 41R800
PAF: REG
COUNTRIES: All
MANUFACTURER/
SHIPPER: All
CHARGE: "The article is subject to refusal of admission pursuant to
section 801(a)(3) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) because it appears to be a biological product
for which a biologics license is not in effect under Section
351(a) of the Public Health Service Act, and therefore it
appears to be a new drug under the meaning of section 201(p)
of the FD&C Act without an effective new drug application
approval, as required by section 505 of the FD&C Act.
[Unapproved new drug, section 505(a)]"
OASIS Charge
Codes: "OASIS Charge Code = Unapproved New Drug"
RECOMMENDING
OFFICE: CBER, Office of Compliance and Biologics Quality, Division
0f Case Management, HFM-624
REASON FOR
ALERT: CBER was informed by New Orleans District Office (NOL-DO)
that they are seeing entries of pig whipworm eggs called
Trichuris suis ova (TSO) prescribed as an oral medication
for patients to treat Crohn's Disease and other inflammatory
bowel diseases. NOL-DO has seen approximately 14 FEDEX
Shipments of this product since the beginning of this year.
The entries are declared for personal use only and are
accompanied by a US Physician's prescription. Currently,
there is no new drug application approval or biologics
license application for this product and no IND has been
filed with CBER.
There are published reports of Trichuris suis (pig
whipworms) infection in humans including a report published
in 2006 of a pediatric patient with Crohn's disease
receiving five oral doses of T. suis ova (TSO) and
subsequently becoming infected with live sexually immature
worms within the ileocecal region and a sexually mature worm
within the luminal space of the bowel (Arch Pathol Lab Med.
Vol 130 May 2006). In addition, two earlier reports also
suggest that T. suis is capable of infecting human hosts
[Shin et al Can J Gastroenterol 2004 Mar;18(3) and Beer Res
Vet Sci 1976 Jan; 20(1)]. The adverse events associated
with a T. suis infection are currently unknown; however,
infestation in humans with Trichuris has been implicated in
causing inflammation of the bowel [Ferrari et al Endoscopy
1993 Oct 25(8)], and possibly increasing the pathogenicity
of Camplyobacter jejuni, thus increasing the severity of C.
jejuni colitis if there is concomitant infection [Shin et al
Can J Gastroenterol 2004 Mar; 18(3)].
In addition to the safety concerns described above, the FDA
also has concerns regarding the product's safety as the
Agency does not have information regarding the manufacture,
control, and release tests for this product. Specifically,
the Agency has no information with regard to testing for
adventitious agents, including porcine viruses, at the
manufacturing stages and in the final drug product.
Additionally, there is concern regarding the potential
presence of other contaminants and/or allergens within the
oral mixture that patients are being directed to consume.
GUIDANCE: Districts may detain without physical examination all
imported Trichuris suis ova (TSO); Pig Whipworm Eggs or Pig
Whipworm Egg suspensions because these articles appear to be
biological products for which a biologics license is not in
effect under section 351 of the Public Health Service Act
and thus appear to be new drugs under the meaning of section
201(p) of the FD&C Act without an effective new drug
application approval, as required by section 505 of the FD&C
Act. These unlicensed biological products appear to be
offered for import for the treatment of Crohn's Disease and
other inflammatory bowel diseases.
District Offices that have further questions concerning the
entry of TSO; Pig Whipworm Eggs, can contact OCBQ/DCM,
Import/Export Staff at (301) 827- 6201.
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging required
KEY WORDS: Trichuris suis ova, TSO, Pig, Pig Whipworm Eggs, Whipworms,
Whipworm Eggs.
PREPARED BY: Nawab A. Siddiqui, DIOP, 301-594-3871
Kimberly A. Cressotti, CBER/OCBQ/DCM 301-827-6214
Jessica A. Tave,
Dale Slavi (OVRR)
Mark Abdy (OVRR)
DATE LOADED
INTO FIARS: May 10, 2007
|
