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| | The United States Food and Drug Administration is skeptical of the Clinic's claims. It sued the Clinic, alleging the stem cell procedure violates the Federal Food, Drug, and Cosmetics Act (codified at 21 U.S.C. §§ 301 et seq.). The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective. The Clinic appeals, arguing it is exempt from regulation because the procedure falls into either the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. See 21 C.F.R. § 1271.15(b); id. § 1271.10. We disagree: The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed and the procedure does not fall within the second exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. We therefore affirm the judgment of the district court.}} | | The United States Food and Drug Administration is skeptical of the Clinic's claims. It sued the Clinic, alleging the stem cell procedure violates the Federal Food, Drug, and Cosmetics Act (codified at 21 U.S.C. §§ 301 et seq.). The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective. The Clinic appeals, arguing it is exempt from regulation because the procedure falls into either the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. See 21 C.F.R. § 1271.15(b); id. § 1271.10. We disagree: The procedure does not fall within the first exception because the biological material implanted into the patient is not the same as that removed and the procedure does not fall within the second exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. We therefore affirm the judgment of the district court.}} |
| | ''United States v. US Stem Cell Clinic, Ltd. Liab. Co.'', 998 F.3d 1302, 1304 (11th Cir. 2021). | | ''United States v. US Stem Cell Clinic, Ltd. Liab. Co.'', 998 F.3d 1302, 1304 (11th Cir. 2021). |
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| | + | This decision is notable for its passage against finding ambiguity in a regulation, and then deferring to a federal agency: |
| | + | {{cquote|There was a time when a court faced with a regulation that seemed "impenetrable on first read" might simply "wave the ambiguity flag" and defer to the agency's interpretation. ''Kisor v. Wilkie'', 139 S. Ct. 2400, 2415, 204 L. Ed. 2d 841 (2019). No longer. The Supreme Court recently clarified that judicial deference is appropriate only if a regulation is "genuinely ambiguous." Id. Before declaring a regulation genuinely ambiguous, we must "exhaust all the traditional tools of construction," which entails "carefully consider[ing] the text, structure, history, and purpose of [the] regulation." Id. (internal quotation marks omitted). We will consider the parties' textual arguments, giving the agency's view no special weight "except to the extent it has the 'power to persuade.'" Id. at 2414 (quoting ''Skidmore v. Swift & Co.'', 323 U.S. 134, 140, 65 S. Ct. 161, 89 L. Ed. 124 (1944) ("The weight of [an agency's interpretation] will depend upon the thoroughness evident in its consideration, the validity of its reasoning, [and] its consistency with earlier and later pronouncements")). In this case, our tools of construction resolve the apparent ambiguity in the FDA's favor, so we need not decide whether to defer to the interpretation expressed in the Guidance Document.}} |
| | + | ''United States v. US Stem Cell Clinic, Ltd. Liab. Co.'', 998 F.3d 1302, 1308 (11th Cir. 2021). |
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| | + | The [[Eleventh Circuit]] concluded that the stem cells were modified enough in the same-surgery procedure at issue in that case to make them drugs subject to FDA authority to prohibit: |
| | + | {{cquote|Because the plain text of the regulation suggests that "such HCT/Ps" must be in their original form (rather than subjected to extensive processing), and because this understanding is confirmed by the agency's contemporaneous statements and its later, thoroughly-considered interpretation, we hold the same surgical procedure exception unambiguously does not apply to the Clinic's procedure. The stromal-vascular fraction solution is the product of an intensive cell isolation process involving enzymatic digestion that goes much farther than simple rinsing or sizing. By the time the stromal-vascular fraction is reinjected, it is no longer "such HCT/P" as the adipose tissue removed from the patient.}} |
| | + | ''United States v. US Stem Cell Clinic, Ltd. Liab. Co.'', 998 F.3d 1302, 1310 (11th Cir. 2021) |
| | + | === District Court === |
| | + | The district court did not rely on a guidance by the FDA: |
| | + | {{cquote|In conclusion, the Guidance is not, by its terms [**36] or by the FDA's interpretation, "legally binding" and, even if the FDA considered it as such, it would be irrelevant to the disposition of this action. ''See'' ''United States v. Regenerative Scis., LLC'', 741 F.3d 1314, 1322, 408 U.S. App. D.C. 259 (D.C. Cir. 2014) ("Appellants claim that the FDA seeks to give legal effect to a statement that was not promulgated through formal rule-making procedures . . . Our decision, however, is based on, and gives effect to, the Part 1271 Regulations, not the preamble. Appellants' procedural challenge to the preamble is therefore irrelevant."). Congress has delegated to the FDA substantial discretion in the regulation of drugs and biological products, its interpretation of § 1271.15(b) is neither facially inconsistent nor otherwise plainly erroneous and is historically consistent with the FDA's position regarding the regulation of HCTP's. Therefore, the FDA's interpretation of the same surgical procedure exception in 21 C.F.R. § 1271.15(b) is entitled to deference under Auer.9 519 U.S. 452, 117 S. Ct. 905, 137 L. Ed. 2d 79. Under this interpretation, "such HCT/P" implanted into the patient refers to all of the HCT/P removed from the patient in its original form, subject to limited handling. As Defendants' SVF therapy extracts adipose tissue, but only implants the SVF into the patient, after subjecting it to a specific and complex multi-step procedure, the HCT/P is no longer in its original form. Thus, the same surgical procedure exception does not and cannot apply to Defendants as a matter of law, and they are therefore subject to FDA regulation. As this is the sole issue on which Defendants move for summary judgment, the Court denies Defendants' Motion and grants the FDA's Motion on this issue.}} |
| | + | ''United States v. US Stem Cell Clinic, LLC'', 403 F. Supp. 3d 1279, 1296 (S.D. Fla. 2019). |
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| | + | == D.C. Circuit == |
| | + | The leading (and perhaps only) case in the [[D.C. Circuit]] on this issue was ''United States v. Regenerative Scis., LLC'', 741 F.3d 1314, 1322, 408 U.S. App. D.C. 259 (D.C. Cir. 2014), which held in favor of the FDA. |
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| | == Analogous therapies == | | == Analogous therapies == |
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