[Federal Register: December 8, 2003 (Volume 68, Number 235)]
[Page 68402-68403]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0529]

Amending the MedWatch Forms to Collect Postmarketing Adverse 
Event Data Relating to Race and Ethnicity

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is requesting comment 
on the advantages and disadvantages of systematically collecting race 
and ethnicity data in postmarketing adverse event reports. FDA is also 
seeking feedback on whether FDA's MedWatch forms (Forms 3500 and 3500A) 
should be amended to collect the race and ethnicity data. If the 
MedWatch forms are amended to collect race and ethnicity data, FDA 
would like comment on how the forms should be amended and the financial 
impact of amending the forms on both voluntary and mandatory reporters. 
FDA is also asking for comment on the implications that collecting such 
race and ethnicity data would have for international reporting of 
postmarketing adverse events.

DATES: Submit written or electronic comments on this document by 
February 6, 2004.

ADDRESSES: Submit written comments on identified questions 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 The MedWatch forms are available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/MedWatch.

FOR FURTHER INFORMATION CONTACT: Brenda Evelyn, Office of Special 
Health Issues (HF-12), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4460, bevelyn@oc.fda.gov.


I. Background

A. FDA Regulations

    FDA regulations require sponsors to present an analysis of data 
according to demographic subgroups (age, gender, race), as well as an 
analysis of modifications of dose or dosage intervals for specific 
subgroups (21 CFR 314.50(d)(5)(vi)(a)) in certain marketing 

B. MedWatch Forms

    Medwatch Forms FDA 3500 and 3500A are used by voluntary and 
mandatory reporters, respectively, to collect information on adverse 
events, product quality problems, and medication errors that occur 
during marketed use of FDA-regulated products. The MedWatch forms 
collect demographic and other information about patients in the patient 
information section (box A), which includes specific data fields for 
age (box A.2), sex (box A.3), and weight (box A.4). The forms do not, 
however, include a unique field to capture data on race and ethnicity. 
Race and ethnicity data can be collected in box B.7 of the MedWatch 
forms, however, other information is collected in box B.7, including 
information on preexisting medical conditions (e.g., allergies, 
pregnancy, smoking and alcohol use, hepatic/renal dysfunction). In 
addition, the information captured in this section is in a narrative 
format and cannot be searched efficiently to extract race and ethnicity 
data. Thus, current placement of race and ethnicity data in box B.7 of 
the MedWatch forms limits the ability of FDA to analyze postmarketing 
adverse event data by race and ethnicity.

C. Office of Management and Budget (OMB) Recommendations and FDA Draft 

    In 1997, OMB issued recommendations for the collection and use of 
race and ethnicity data by Federal agencies (Statistical Policy 
Directive No. 15, Race and Ethnic Standards for Federal Statistics and 
Administrative Reporting, 1997). In the Federal Register of January 30, 
2003, FDA made available for comment a draft guidance for industry 
entitled ``Collection of Race and Ethnicity Data in Clinical Trials'' 
(68 FR 4788). In the draft guidance, FDA recommends the use of 
standardized OMB race and ethnicity categories for data collection in 
clinical trials. The agency's recommendations are intended to ensure 
consistency in the analyses of demographic subsets across studies and 
to help evaluate potential differences in the safety and efficacy of 
pharmaceutical products among population subgroups.
    With respect to collection of the data, in the draft guidance, the 
agency provided the following recommendations:
    1. A two-question format should be used for requesting race and 
ethnicity information, with the ethnicity question preceding the 
question about race.
    2. Study participants should self-report race and ethnicity 
information whenever feasible, and individuals should 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), we recommend the information be requested from a first-degree 
relative or other knowledgeable source.
    3. For ethnicity, the following minimum choices should be offered:
    [sbull] Hispanic or Latino
    [sbull] Not Hispanic or Latino
    4. When race and ethnicity information is collected separately, the 
following minimum choices should be offered for race:
    [sbull] American Indian or Alaska Native
    [sbull] Asian
    [sbull] Black or African American
    [sbull] Native Hawaiian or Other Pacific Islander
    [sbull] White
    5. In certain situations, as directed 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, these characterizations should be traceable 
to the five minimum designations for race and two designations for 
ethnicity listed under numbers 3 and 4 in section I.C of this document.

D. ICH Guidance

    In 1998, as part of an international effort among Japan, the 
European Union, and the United States to harmonize technical 
requirements for pharmaceutical drug development and regulation (ICH 
(International Conference on Harmonisation)), FDA published a guidance 
entitled ``E5

[[Page 68403]]

Ethnic Factors in the Acceptability of Foreign Clinical Data'' (63 FR 
31790, June 10, 1998). The E5 guidance provides recommendations to 
permit the clinical data collected in one region to be used in the 
registration or approval of a drug or biological product in another 
region, while allowing for the influence of ethnic factors. The E5 
guidance defines ethnic factors that could affect drug response in 
terms of both intrinsic and extrinsic issues. Because there is the 
potential for differences in the safety and efficacy of pharmaceutical 
products among population subgroups, the E5 guidance provides a general 
framework for how to evaluate medicines with regard to ethnic factors.

II. Scope of Discussion

    In view of the background information presented in section I of 
this document, FDA is requesting comment on the advantages and 
disadvantages of collecting race and ethnicity data in postmarketing 
adverse event reports. FDA is also seeking feedback on whether the 
MedWatch forms should be amended to collect this data based on the 
standardized categories described in section I.B of this document. 
Specific comments are being sought on the following questions:
    1. Should the MedWatch forms (Forms FDA 3500A and 3500) be amended 
with a special field or fields to capture adverse event data on race 
and ethnicity?
    2. Should MedWatch race and ethnicity data distinguish between 
self-reported and observer-reported designations? If so, how should the 
designations be captured?
    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))?
    4. What is the financial impact associated with adding a special 
field or fields to the MedWatch forms to collect data on race and 

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments. Two copies of any 
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. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: November 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-30300 Filed 12-5-03; 8:45 am]