[Federal Register: July 13, 2004 (Volume 69, Number 133)]
[Page 42060-42061]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0279]

Developing Drug Information Association/Food and Drug 
Administration Workshop: Pharmacogenomic Combination Product Co-
Development; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


SUMMARY: The Food and Drug Administration (FDA), in cooperation with 
the Drug Information Association (DIA), is announcing a public meeting 
to solicit views and to provide an interactive forum for discussion of 
industry and other perspectives and experience derived from the 
development of recently approved pharmacogenomic combination products. 
The input received at the meeting, comments received during the 
meeting, and comments made to the docket after the meeting, may be 
considered in developing a draft guidance on this topic.

DATES: The public meeting will be held on July 29, 2004, from 8 a.m. to 
5:30 p.m. Attendees must register to attend. Submit written or 
electronic requests to speak at the public meeting by July 26, 2004. 
Submit written or electronic comments before or after the meeting by 
August 30, 2004.

ADDRESSES: The public meeting will be held at the Marriott Crystal 
Gateway Hotel, 1700 Jefferson Davis Hwy., Arlington, VA. A copy of the 
meeting's program is available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.diahome.org/Content/Events/04040.pdf

    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments


[[Page 42061]]

Those wishing to speak should contact: Allen Rudman, Office of Clinical 
Pharmacology and Biopharmaceutics, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7691, e-mail: 
Those wishing to register for the meeting should contact: Drug 
Information Association, P.O. Box 827192, Philadelphia, PA 19182-7192, 


I. Background

    FDA is embarking on a new initiative to develop guidance for the 
codevelopment of pharmacogenomic-based therapeutic drug and biological 
products and the diagnostic tests that are necessary for therapeutic 
decision making. A number of diagnostic tests could be developed for 
use with drug or biological products including, for example, tests 
related to treatment decisions, such as whether patients should be 
treated, the dose used for treatment, or to identify the risks 
associated with treatment. FDA expects to develop guidance for the 
codevelopment of therapeutic and diagnostic products where both will be 
necessary in the clinical management of patients.
    In preparation for drafting the guidance, FDA and DIA have planned 
a 1-day mini-meeting, in collaboration with Pharmaceutical Research and 
Manufacturers of America, Biotechnology Industry Organization, Advanced 
Medical Technology Association, Medical Device Manufacturers 
Association, the DIA Biotechnology Special Interest Action Committee, 
and the Pharmacogenomics Working Group, to identify important issues 
related to the codevelopment of pharmacogenomic combination products. 
FDA believes it is important to receive input from industry and other 
interested parties through a public meeting before drafting the 
    Previously, FDA and industry have cosponsored two multi-day 
meetings on pharmacogenomics in May 2002 and November 2003, 
respectively. This collaboration between industry, FDA, and other 
interested parties has also facilitated the writing and issuance of the 
draft guidance for industry entitled ``Pharmacogenomic Data 
Submissions,'' which was issued in November 2003 and is currently being 

II. Goals of the Meeting

    The primary intent of this mini-meeting is to provide an 
interactive forum for discussing industry and other perspectives and 
experience derived from the development of recently approved 
pharmacogenomic combination products. This meeting is intended to be 
highly interactive, identify issues, and address questions that will 
provide FDA with valuable information to consider during development of 
guidance for industry on the codevelopment of pharmacogenomic 
combination products for therapeutic and diagnostic use.
    Key areas identified for particular focus include the following:
     Industry vision of an ideal codevelopment process and 
regulatory framework,
     Clinical trial design and statistical challenges for the 
codevelopment of therapeutic and diagnostic pharmacogenomic products,
     Case studies to explore detailed considerations for the 
analytical validation of pharmacogenomic diagnostic products, and
     Clinical utility of pharmacogenomic diagnostic products.
    Specific goals of the meeting include the following:
    1. Provide greater awareness and understanding of the regulatory 
and scientific challenges of codeveloping pharmacogenomic combination 
    2. Obtain greater clarity on the clinical and statistical design 
issues that affect the codevelopment of drug and pharmacogenomic 
combination products.
    3. Provide an opportunity to help define the elements that are 
needed in guidance for industry to enhance the codevelopment of 
pharmaogenomic combination products.
    4. Provide pharmaceutical, biological product, device industries, 
and other public stakeholders with an opportunity to identify issues 
and propose recommendations for FDA consideration as it develops formal 
guidance on the codevelopment of pharmaogenomic combination products.

III. Intended Audience

    This meeting is intended for developers and potential developers of 
therapeutic drug and biological products and pharmacogenomic-based 
diagnostic products to be developed and approved with them as 
combination products. Other interested persons may include regulatory/
clinical decision-makers, designers of clinical and laboratory 
validation protocols, clinical pharmacologists, physicians, 
biostatisticians, and geneticists working in industry or academia.

IV. Request for Comments

    Regardless of attendance at the meeting, interested persons may 
submit to the Division of Dockets Management (see ADDRESSES) written or 
electronic comments on the topics presented in this document. The 
agency welcomes comments before and after the meeting. Two paper copies 
of mailed comments are to be submitted, except that individuals may 
submit one paper copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. Received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 8, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-15935 Filed 7-9-04; 2:24 pm]