[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DATES: Submit written or electronic comments on the draft guidance by 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    FDA is announcing the availability of a draft guidance for industry 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