Auer deference refers to a rule in administrative law that interpretive rules by federal agencies should have the force of law because an agency’s interpretation of its own regulations are to be respected. This principle was established by Auer v. Robbins, 519 U. S. 452 (1997), and Bowles v. Seminole Rock & Sand Co., 325 U. S. 410 (1945).
There are important exceptions to Auer deference, including:
- a reviewing court should still ultimately decide whether a given regulation means what the agency says.
- Auer deference is inappropriate “when the agency’s interpretation is plainly erroneous or inconsistent with the regulation” or “when there is reason to suspect that the agency’s interpretation does not reflect the agency’s fair and considered judgment.” Christopher v. SmithKline Beecham Corp., 132 S. Ct. 2156, 183 L. Ed. 2d 153, 169 (2012) (internal quotation marks omitted)
- “[A]n agency’s interpretation of a ... regulation that conflicts with a prior interpretation is entitled to considerably less deference than a consistently held agency view.” Thomas Jefferson Univ. v. Shalala, 512 U. S. 504, 515, 114 S. Ct. 2381, 129 L. Ed. 2d 405 (1994) (internal quotation marks omitted).
See generally Perez v. Mortg. Bankers Ass'n, 135 S. Ct. 1199, 1208 n.4 (2015).
Rejected concerning abortion drug
In the litigation against the chemical abortion drug, mifepristone, the federal district court properly rejected Auer deference:
| “ | Auer deference is not appropriate because "the language of [the] regulation is plain and unambiguous." McCann v. Unum Provident, 907 F.3d 130, 144 (3d Cir. 2018). As explained, FDA's definitions in prior rulemakings foreclose its interpretation of Subpart H. If there is any ambiguity in "serious or life-threatening illnesses," the ordinary meaning principle resolves that ambiguity. See Bostock, 140 S. Ct. at 1825 (Kavanaugh, J, dissenting) ("The ordinary meaning principle is longstanding and well settled."). "[C]ommon parlance matters in assessing the ordinary meaning" of a statute or regulation "because courts heed how most people would have understood the text." Id. at 1828 (internal marks omitted). The word "illness" refers to "poor health; sickness," or "a specific sickness or disease, or an instance of such."32 Merriam-Webster invokes the definition for "sickness" — "an unhealthy condition of body or mind." Likewise, a Wikipedia search for "illness" re-directs to the entry for "Disease," which is defined as "a particular abnormal condition that negatively affects the structure or function of all or part of an organism, and that is not immediately due to any external injury." Pregnancy, on the other hand, is defined as "the time during which one or more offspring develops (gestates) inside a woman's uterus (womb)."
Most readers would not define pregnancy to be a serious or life-threatening illness. Even FDA does not earnestly defend that position. True, complications can arise during pregnancy, and said complications can be serious or life-threatening. But that does not make pregnancy itself an illness. See ECF No 1-13 at 21. And even if the regulation were genuinely ambiguous after exhausting all traditional tools of statutory construction, Defendants' interpretation: (1) is not reasonable; (2) does not implicate their substantive expertise; and (3) does not reflect fair and considered judgment. Accordingly, Defendants are not entitled to Auer deference on their interpretations of "serious or life-threatening illnesses." By interpreting Subpart H's scope as reaching any state or side effect that can be considered an undefined "condition," Defendants broaden the regulation on accelerated approval of new drugs farther than the text of the regulation would ever suggest. Therefore, FDA's approval of chemical abortion drugs under Subpart H exceeded its authority under the regulation's first requirement. |
” |
All. for Hippocratic Med. v. United States FDA, No. 2:22-CV-223-Z, 2023 U.S. Dist. LEXIS 61474, at *61-63 (N.D. Tex. Apr. 7, 2023) (footnotes omitted).