A new guidance document published by the US Food and Drug Administration (FDA) aims to clarify the meaning of "spouse" in an era where that no longer means "man and wife."
FDA's guidance comes in the wake of a June 2013 Supreme Court decision in the case of United States vs. Windsor in which the court struck down Section 3 of the Defense of Marriage Act (DOMA) as unconstitutional.
In the US, the act of marriage is regulated not at the federal level, but rather at the state level. Rather than force a married couple to re-register their marriage each time they move to a new state, most states recognize marriages registered in other states. The key word there: most.
DOMA, enacted in 1996, permitted states to refuse to recognize marriages permitted in other states-specifically, marriages between two people of the same sex. The law also prevented federal agencies from recognizing same-sex marriages, meaning gay couples could not jointly file taxes, collect survivor Social Security benefits, or any number of other federal benefits.
The law was eventually struck down on the grounds that it violated the due process and equal protection rights of same-sex couples, leading to widespread changes in the way the federal government treats same-sex couples.
How it Affects FDA
So what does this have to do with FDA and medical product regulation?
Many regulations promulgated by FDA involve the terms "spouse" and "family," most notably its clinical trials regulations.
For example, 21 CFR 50.3, FDA's regulation on the Protection of Human Subjects, defines "family member" as:
any one of the following legally competent persons: Spouse; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.
Another example: In 21 CFR 54.2, FDA's financial disclosure regulation for clinical investigators, the agency also requires a clinical investigator to report conflicted holdings owned by a spouse to ensure an absence of conflict.
Other affected regulations include:
- 21 CFR 20.44 -- (related to FOIA)
- 21 CFR 56.107(d) -- (financial interest reporting)
- 21 CFR 516.141(g)(2) - on expert panels for animal drugs
- 21 CFR 900.2(k) - complaint systems used by mammography facilities
Under previous interpretations, "spouse" only meant a married couple comprised of a man and a woman. After the invalidation of DOMA, FDA says it "will interpret the terms 'spouse' and 'family' in our regulations in light of this ruling."
This policy will be in effect regardless of the state (or country) in which a trial or other FDA-regulated activity is conducted, FDA said. This means that even if a trial is conducted in a state where gay marriage remains illegal, or even a country where it is not legal, FDA's regulatory requirements will still apply.
This, FDA said, served to further the underlying goals of its regulations. "For example," FDA wrote, "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."
The Meaning of "Spouse" and "Family" in FDA's Regulations after the Supreme Court's Ruling in United States v. Windsor (FR)