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height="0.9263888888888889in"}![](media/image1.png){width="2.30625in"
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1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

1012 Tenth Street, Northwest Randall W. Maxey, M.D., Ph.D.

Washington, D.C. 20001- 4492
President![](media/image1.png){width="2.30625in"
height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

![](media/image1.png){width="2.30625in" height="0.9263888888888889in"}

1012 Tenth Street, Northwest L. Natalie Carroll, M.D.

Washington, D.C. 20001-4492 President

\(202\) 347-1895 Fax (202) 842-3293

www.NMAnet.org

\(202\) 347-1895 Fax (202) 371-1162

February 5, 2004

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20857

Re: Amending the MedWatch Forms to Collect Postmarketing Adverse Event
Data Relating to Race and Ethnicity. Docket No.: 2003N-0529

Federal Register: December 8, 2003 (Volume 68, Number 235. Page
68402-68403)

The National Medical Association (NMA) is pleased to respond to the Food
and Drug Administration (Agency) request for comment on "Amending the
MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to
Race and Ethnicity." MedWatch currently does not mandate a policy of
reporting of the patient's racial or ethnic origin. The lack of such
information may result in significant delays in the reporting of adverse
events that may vary as a function of race/ethnicity and as a result
could inflict unnecessary morbidity upon African Americans and other
communities of color.

The NMA is concerned that the paucity of clinical data and consequently
the lack of guidance provided to physicians may be one of many factors
contributing to the well-documented health disparities between Whites
and minorities in the population. We are encouraged by the Agency's
proactive position in seeking comments on this important issue and we
strongly encourage that MedWatch and other adverse event reporting
systems request the submitter (health professionals and/or consumers) to
include information on the race/ethnicity of the patient experiencing
the adverse event.

Ethnic differences in the pharmacokinetics and pharmacodynamics of
certain drugs have been demonstrated in clinical trials.^1-3^ Race and
ethnicity may also be associated with variation in disease morbidity and
mortality. Pharmacogenetic research has supported the occurrence of
racial and ethnic differences in metabolism rates, clinical drug
responses, and adverse effects for the past 35 years.^4-8^ To a large
degree, the established discipline of pharmacogenetics evolved from an
observation of higher prevalence of hemolysis in African Americans and
other people of color who were given antimalaria chemoprophylaxis. This
led to the discovery of higher prevalence of *G6PD* deficiency in
African Americans and its consequences. More recently,

Dockets Management Branch (HFA-305)

Food and Drug Administration

February 5, 2004

Page 2

angioedema associated with use of ACE inhibitors have been observed to
occur more frequently in African-Americans. These examples suggest the
possibility that collection of these data may be instrumental in our
fundamental understanding of disease processes.

The marketing of a multitude of products to African Americans without
valid clinical data supporting safety and effectiveness in our
population, and without adequate labeling to inform physicians, condones
the conduct of uncontrolled clinical testing with each administration.
The lack of consistent, rigorously controlled postmarketing follow-up on
a large scale suggests a serious inability to discern the impact of
these practices on morbidity and mortality in the African American
population.

Questions asked by the Agency in "Amending the MedWatch Forms to Collect
Postmarketing Adverse Event Data Relating to Race and Ethnicity"
include:

1\) Should the MedWatch forms be amended with a special field or fields
to capture adverse event data on race and ethnicity?

Yes, MedWatch forms should be revised/amended to include information
about the patient's race/ethnicity. The NMA is in agreement with
statements reported in 2003 by Ms. Katherine Hollinger, Senior Health
Promotions Officer in the Agency's Office of Women's Health, who when
discussing the draft guidance on race and ethnicity data stated that
"having the additional access to race/ethnicity data will enhance the
Agency's ability to make assumptions based on sub-population
characterizations. This in turn will improve the Agencies ability to
assess potential differences in the ways various racial/ethnic groups
respond to drugs." ^9^ The availability of this data to health care
professionals will have the added benefit to assist them in
better-informed decisions regarding treatment regimens, which can only
result in improved medical care of all communities.

2\) Should MedWatch race and ethnicity distinguish between self-reported
and observer-reported designations? If so, how should the designations
be captured?

Yes, MedWatch should distinguish between self-reported and
observer-reported designations. To account for multiple races, as with
the Office of Management and Budget (OMB) Directive 15, we recommend
that individuals be allowed to identify "more than one category of race"
as a means of reporting diverse ancestry.

The National Medical Association, recommends the use of the standardized
approach to the collection of race/ethnicity data and supports the use
of the Office of Management and Budget (OMB) guidelines, (referenced in
the Agency's Draft **"**Guidance for Industry: Collection of Race and
Ethnicity Data in Clinical Trials), until more scientifically rigorous
standards are available.

Dockets Management Branch (HFA-305)

Food and Drug Administration

February 5, 2004

Page 3

The OMB recommendations are as follows:

-   Use a two-question format for requesting race and ethnicity
    information, with the ethnicity question preceding the question
    about race.

-   That study participants self-report race and ethnicity information
    whenever feasible, and individuals be permitted to designate a
    multiracial identity. When the collection of self-reported
    designations is infeasible (e.g., because of the subject's inability
    to respond), it was recommended the information be requested from a
    first-degree relative or other knowledgeable source.

-   In regards to ethnicity, an individual be given the following
    minimum choices:

-   Hispanic or Latino

-   Not Hispanic or Latino

-   When race and ethnicity information is collected, it was recommended
    the following minimum choices be offered for race:

-   American Indian or Alaska Native

-   Asian

-   Black or African American

-   Native Hawaiian or Other Pacific Islander

-   White

-   In certain situations, as recommended in OMB Directive 15, more
    detailed race and ethnicity information may be desired (e.g.,
    *White* can reflect origins in Europe, the Middle East, or North
    Africa; *Asian* can reflect origins from areas ranging from India to
    Japan). If more detailed characterizations of race or ethnicity are
    collected to enhance data consistency, it was recommended that these
    characterizations be traceable to the five minimum designations for
    race and two designations for ethnicity listed in numbers in the
    preceding two bullets.

There are certain limitations in using self-reported and
observer-reported designations. According to the American
Anthropological Association (AAA), research has shown substantial
differences of racial/ethnic identification by these two methods. To
account for multiple races, OMB recommended that respondents be allowed
to report "more than one race." The AAA supports the OMB Directive 15
proposal to allow respondents to identify "more than one" category of
"race/ethnicity" as a means of reporting diverse ancestry. ^10^ The
National Medical Association believes that even with the limitations of
self and observer reporting systems, the information generated can aid
in reducing medical errors and associated adverse events.

3\) Would collection of race and ethnicity data on the MedWatch forms
have an impact on the ICH E2B guidance relating to the electronic
submission of adverse event reports? ("E2B

> Data Elements for Transmission of Individual Case Safety Reports"
> \[(63 FR 2396 at 2397, January 15, 1998\]).

Dockets Management Branch (HFA-305)

Food and Drug Administration

February 5, 2004

Page 4

Yes, the collection of race and ethnicity data on the MedWatch forms
would have an impact on the ICH E2B guidance relating to the electronic
submission of adverse event reports. However, it recommended that such
guidance or forms be revised to be consistent with any new MedWatch
reporting requirements. It is important that all information be
transparent and able to roll up into one global database of information.

4\) What is the financial impact associated with adding a special field
or fields to the MedWatch forms to collect data on race and ethnicity?

The National Medical Association would assume that any change in the
"status quo", such as adding race and ethnicity fields to the MedWatch
forms would have some associated financial impact. However, it is our
position that the benefits of having this information and potentially
saving lives and reducing health disparities in the United States will
out weight the anticipated financial costs.

We appreciate the opportunity to comment on this important initiative.
The National Medical Association looks forward to future policies or
guidelines recommending methods for analyzing and reporting race and
ethnicity data.

![](media/image2.png){width="4.146527777777778in"
height="0.6319444444444444in"}

Sincerely,

Randall Maxey, M.D., Ph.D.

President, National Medical Association

1.  Johnson JA. Influence of race or ethnicity on pharmacokinetics of
    drugs. *J Pharm Sci*. 1997;8666:1328-1333.

2.  Kalow W. Interethnic variation of drug metabolism. *Trends Pharacol
    Sci*. 1991;12:102-107.

3.  Kalow W. Ethnic differences in drug metabolism. *Clin
    Pharmacokinet*. 1982;7:373-400.

4.  Levy RA. *Ethnic and Racial Differences in Response to Medicines:
    Preserving Individualized Therapy in Managed Pharmaceutical
    Programs*. Publication of the National Pharmaceutical Council, 1993.

5.  Burroughs, VJ, Maxey RW, Levy RA. *Racial and Ethnic Differences in
    Response to Medicines: Towards Individualized Pharmaceutical
    Treatment*. JNMA (suppl 10). 2003.

6.  Strickland TL, Ranganath V, Lin KM, Poland RE, Mendoza R, Smith MW.
    Psychopharmacologic considerations in the treatment of black
    American populations. *Psychopharacol Bull*. 1991;27:441-448.

7.  Smith MW, Mendoza RP. Ethnicity and pharmacogentics. *Mt Sinai J
    Med*. 1996;63:285-290.

8.  Lin KM, Poland RE, Wan Y, Smith MW, Lesser IM. The evolving science
    of pharmacogenetics: clinical and ethnic perspectives.
    *Psychopharmacol Bull*. 1996;32:205-217.

9.  FDA Consumer; 37(3); May-June 2003; p.36.

10. The American Anthropological Association: Response to OMB
    Directive 15. Race and Ethnicity Reporting for Federal Statistics
    and Administrative Reporting (September 1997).
    http://www.aaanet.org/gvt/ombdraft.htm.