The Meaning of Spouse and Family 
in FDAs Regulations after the Supreme 
Courts Ruling in United States v. Windsor
Questions and Answers: Guidance for 
Industry, Consumers, and FDA Staff 
  
 
 
 
 
 
 
 U.S. Department of Health and Human Services  
Food and Drug Administration 
Office of Policy, Office of the Commissioner 
 
April 2014  
 
   
 
     
 
 
 
The Meaning of Spouse and Family 
in FDAs Regulations after the Supreme 
Courts Ruling in United States v. Windsor
Questions and Answers: Guidance for 
Industry, Consumers, and FDA Staff 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional copies of this guidance are available from the Office of Policy, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Avenue, Silver 
Spring, MD 20993, or by calling 301-796-4830, or from the Internet at 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm389748.htm.  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Policy  
Office of the Commissioner 
April 2014 
 
    Table of Contents 
 
I.  INTRODUCTION.....................................................................1 
 
II.              QUESTIONS AND ANSWERS.....................................................1      
Q1:  How does the Supreme Courts United States v. Windsor decision affect 
FDAs regulations?............................................................................................................1 
 
Q2:  Do you have to live or intend to live in a state in which same-sex  
marriage is legal for FDAs regulations using the terms spouse or 
family to apply to you?................................................................................................... 1    
 
Q3: Which FDA regulations are affected by the Windsor decision?  .............................2   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
The Meaning of Spouse and Family 
in FDAs Regulations after the Supreme 
Courts ruling in United States v. Windsor 
Questions and Answers: Guidance for 
Industry, Consumers, and FDA Staff 
 
 
I.  INTRODUCTION 
On June 26, 2013, in United States v. Windsor, 133 S.Ct. 2675, the Supreme Court struck 
down as unconstitutional section 3 of the Defense of Marriage Act (DOMA).  Using a 
question and answer format, we, FDA, are informing the public of our current thinking 
about the meaning of spouse or family in our regulations in light of this ruling. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  
   
II.  QUESTIONS AND ANSWERS 
Q1:  How does the Supreme Courts United States v. Windsor decision affect 
FDAs regulations? 
 
A1:  Section 3 of DOMA defined marriage and spouse to exclude same-sex 
spouses.  Because the Supreme Court ruled this section unconstitutional, FDA 
need no longer exclude same-sex spouses from the definition of these terms.  
Consistent with the Department of Health and Human Service (HHS) policy, FDA 
will interpret the terms spouse and family in its regulations to include same-
sex spouses.  
 
Q2:    Do you have to live or intend to live in a state in which same-sex 
marriage is legal for FDAs regulations using the terms spouse or 
family to apply to you? 
 
A2:  No.  We interpret spouse or family in our regulations to include any 
individuals of the same sex who are lawfully married and whose marriage is valid 
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  in the state, territory or foreign nation where it took place.  These terms also 
include same-sex spouses whose marriages are valid in the state, territory, or 
foreign nation where they live. This policy is consistent with a post-Windsor 
policy of treating same-sex marriages on the same terms as opposite-sex 
marriages to the greatest extent reasonably possible.  By broadening the coverage 
of spouse and family to include same-sex spouses, it also advances the 
underlying goals of FDAs regulations.  For example, requiring clinical 
investigators to disclose the financial interests and arrangements of their same-sex 
spouses (see discussion of FDA Financial Disclosure by Clinical Investigators 
below) better ensures that conflicts of interests do not arise.   
 
Q3:     Which FDA regulations are affected by the Windsor decision?   
 
A3:  Because they use the terms spouse or family, six parts of FDAs 
regulations are affected by the Windsor decision.  Consistent with this decision 
and HHS policy, FDA now reads these terms to include same-sex spouses.  The 
affected regulations are as follows:  
 
  FDA Freedom of Information Act (FOIA) program (21 CFR 20.44 
(b)).  A family member, including a same-sex spouse, of an 
individual subject to an imminent threat may request expedited 
processing of a FOIA request. 
  
  FDA Human Subject Protection  (21 CFR 50.3 (l), (m), 50.24(a)(6), 
(a)(7)(v), (b)). Family member means, among other things, 
spouse, brothers, sisters, and spouses of brothers and sisters, and 
any individual related by . . . affinity whose close association with the 
subject is the equivalent of a family relationship.  An exception from 
the requirement to obtain informed consent of research subjects exists 
if obtaining informed consent is not feasible and a legally authorized 
representative is not reasonably available.  If feasible, an investigator 
must attempt to contact a subjects family member, which can include 
a same-sex spouse, to ask whether he or she objects to the subjects 
participation in the clinical investigation.  Additionally, if a subject 
remains incapacitated and a subjects legally authorized representative 
is not reasonably available, an Institutional Review Board (IRB) shall 
ensure that there is a procedure to inform a family member, which can 
include a same-sex spouse, that he or she may discontinue the 
subjects participation at any time without penalty or loss of benefits to 
which the subject is otherwise entitled.  If such a family member is 
told about the clinical investigation and the subjects condition 
improves, the subject is also to be informed as soon as feasible. If a 
subject is entered into a clinical investigation with waived consent and 
the subject dies before a legally authorized representative or family 
member, which can include a same-sex spouse, can be contacted, 
information about the clinical investigation is to be provided to the 
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  subjects legally authorized representative or such family member, if 
feasible. 
  
  FDA Financial Disclosure by Clinical Investigators (21 CFR 
54.2(d)).  Part 54 of FDAs regulations requires disclosure of certain 
types of financial interests and arrangements involving a clinical 
investigator and defines clinical investigator to include the 
investigators spouse.  Consistent with the Windsor decision and 
HHS policy, FDA now interprets Part 54 to require disclosure of 
certain financial interests and arrangements involving any clinical 
investigators same-sex spouse. 
 
  Institutional Review Board for FDA-regulated Research (21 CFR 
56.107(d)).  Each IRB must have at least one member who is not 
otherwise affiliated with the institution and is not part of the 
immediate family, now including a same-sex spouse, of a person 
affiliated with the institution.   
 
  Qualified Expert Panels for Indexing New Animal Drugs (21 CFR 
516.141(g)(2), (g)(3)). Information required to be submitted to FDA 
and factors considered to prevent conflicts of interest in members of 
these expert panels include information relating to spouses, 
including same-sex spouses. 
 
  Mammography Quality Standards Program (21 CFR 900.2(k)).  
Mammography facilities must have systems for collecting and 
resolving consumer complaints.  Consumer includes a patient or 
patient representativefor example, a family member, including a 
same-sex spouse.  
 
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