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Answer from the FDA

Subject: Answer from the FDA
Author: itchy and miserable
Date: 5/10/2005 1:39 pm
Views: 6408
Status: Approved
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Good morning,

I am writing to you in response to the email below regarding a poison ivy
vaccine. I am not aware of a poison ivy vaccine ever used in the US or
licensed. I do know that in the past, people were treated with a poison ivy
extract to build immunity to poison ivy. In the early 1980's an FDA Advisory
committee recommended to the Agency that a large number of unstandardized
Allergenic Extracts that were licensed many years ago (including injectable
poison ivy extract or PIE )be removed from the market while studies were
being done to determine the products safety and efficacy, consistent with
current laws and regulatory standards. The Advisory Committee, consisting
of nongovernment experts in the field of allergy, recommended the action
because the currently available data demonstrate that the products have an
unfavorable benefit to risk potential. If favorable data could be developed
from any new studies, those data would ser e as the basis for
standardization of the products and support licensure and marketing of them
consistent with the scientific knowledge and legal requirements that exist
today.
On August 8, 1991, FDA informed manufacturers of Allergenic Extract in a
written correspondence that suitable technology exists for standardizing
PIE. Also, under the August 8, 1991 letter, the Agency stated that it would
permit continued marketing of the unstandardized products for a period of
two years while the manufacturers made the transition form producing
unstandardized product to standardized product. At the end of that two year
period ( August 8, 1993), manufacturers would no longer be permitted to
distribute unstandardized product. A copy of an acceptable laboratory
method for standardized potency testing was provided to the manufacturers,
who are responsible for laboratory and clinical testing. Such laboratory
testing, along with development of sufficient clinical data, would be
consistent with the Advisory Committee's recommendations for demonstrating
that these products be safe and effective for their intended uses.
Unfortunately, even after we extended the date more than once for transition
for producing nonstandardized PIE to standardized PIE, no manufacturer
pursued the effort towards production of standardized PIE. In March, 1996,
Parke Davis, the last manufacturer known to be producing injectable PIE,
requested by letter to FDA that its license to produce PIE be revoked. We
granted the company's request in a letter dated June 13, 1996.
Currently, there is a non-biological drug (Bentoquatam 5%, or sold under the
trade name Ivy Block) that has been approved by the FDA's Center for Drug
Evaluation and Research. It is a lotion to be applied prior to exposure to
poison ivy, oak or sumac. It is sold without a prescription. If any
manufacturer expresses an interest to us in producing and marketing an
injectable PIE we would be happy to work with that manufacturer in the
investigation of its product and would review the manufacturer's laboratory,
animal and human clinical data as expeditiously as possible.

I am sorry I do not have any information regarding a vaccine but I hope the
information I provided was useful.

Best regards,

Lanessa Hill
Public Affairs Specialist
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research

SubjectAuthorDate
Answer from the FDA (Approved)itchy and miserable5/10/2005 1:39 pm
  Re: Answer from the FDA (Approved)jason7/6/2005 4:32 pm