Moving quickly to erase the Defense of Marriage Act struck down by the Supreme Court last year, the Obama administration has rewritten the definition of “marriage” and “family” to include same-sex spouses and family members as anyone with a “close" relationship.
In a notice published Wednesday, the Food and Drug Administration issued new "guidance," determining that a family member is, "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.'"
The FDA said the change will impact several areas of coverage, including mammography and consent for incapacitated family members.
The change follows the court’s decision to strike down part of the Defense of Marriage Act which excluded same-sex relationships.
Several states allow same-sex marriages and the FDA said that it will recognize all valid same-sex marriages even if the individuals don’t live in a state that approves of their marriage.
Below are the key elements of the FDA’s guidance:
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.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s 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 Court’s United States v. Windsor decision affect FDA’s 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 FDA’s 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 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 FDA’s 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.
Paul Bedard, the Washington Examiner's "Washington Secrets" columnist, can be contacted at firstname.lastname@example.org.