[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Notices]
[Page 28931-28932]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my04-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0228]
Guidance for Industry on Fixed Dose Combination and Co-Packaged
Drug Products for Treatment of HIV; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Fixed Dose
Combination and Co-Packaged Drug Products for Treatment of HIV.'' This
guidance is intended to encourage sponsors to develop fixed dose
combinations (FDC) and co-packaged products for the treatment of human
immunodeficiency virus (HIV) infection. The availability of combination
products may help to improve patient adherence to and facilitate
distribution programs for treatment regimens for HIV.
DATES: Submit written or electronic comments on the draft guidance by
July 19, 2004. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the guidance to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Debra B. Birnkrant, Center for Drug
Evaluation and Research (HFD-530), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301 827-2330.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Fixed Dose Combination and Co-Packaged Drug Products for
Treatment of HIV.'' This guidance is intended to encourage the
development of fixed dose combination (FDC) and co-packaged products
for the treatment of human immunodeficiency virus (HIV). The guidance
addresses the agency's current thinking regarding the types of
information that should be provided in an application seeking approval
for an
[[Page 28932]]
FDC or co-packaged product for the treatment of HIV.
Combination therapy is essential for the treatment of HIV/AIDS. At
least three active drugs, usually from two different classes, are
required to suppress the virus, allow recovery of the immune system,
and reduce the emergence of HIV resistance. In the United States and
developing countries, simplified HIV regimens in the form of co-
packaged drugs (such as blister packs) or FDCs may facilitate
distribution of antiretroviral therapies and improve patient adherence
to the regimens.
Although there are more than 20 unique antiretroviral drugs
approved in the United States, only a few are approved for use as FDC
products, and none are approved as co-packaged products. Some
antiretrovirals should not be combined due to overlapping toxicities
and potential viral antagonism. Other antiretrovirals should not be
used in pregnant women and other special populations. It is important,
therefore, that possible combinations of these products be evaluated
for safety and efficacy in the various populations that may have need
of them.
Recently, newer FDCs that have not been approved by FDA have
received attention, and some are being promoted for use in resource
poor nations where HIV/AIDS has reached epidemic proportions. These
FDCs may offer cost advantages and allow simplified dosing because all
three drugs are in one pill. However, the safety, efficacy, and quality
of these products have not been evaluated by FDA. Products whose
safety, efficacy, and quality do not conform to expected standards may
pose a threat to individual patients by increasing the chances of
substandard performance, which may lead not only to treatment failure,
but also to the development and spread of resistant virus.
FDA is prepared to move swiftly to evaluate such products when
applications for them are submitted for approval. This guidance seeks
to clarify what regulatory requirements would be applied to such
applications, what issues might be of concern, and how these should be
addressed. Different considerations apply depending on whether a
sponsor owns or has a right of reference to all of the data required to
support an application or a sponsor plans to rely on literature or the
FDA's findings of safety and effectiveness for an approved drug. Where
appropriate, this guidance addresses the issues associated with these
different scenarios.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on FDC and co-packaged products for treating
HIV infection. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit written comments on the guidance to
the Division of Dockets Management (see ADDRESSES). Two copies of
mailed comments are to be submitted, except that individuals may submit
one copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The guidance and received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.
Dated: May 14, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11364 Filed 5-17-04; 11:05 am]
BILLING CODE 4160-01-S