Advanced Integrative Med. Sci. Inst., PLLC v. Garland

Decision Date31 January 2022
Docket NumberNo. 21-70544,21-70544
Citation24 F.4th 1249
Parties ADVANCED INTEGRATIVE MEDICAL SCIENCE INSTITUTE, PLLC; Sunil Aggarwal, Doctor, MD, PhD, FAAPMR; Erinn Baldeschwiler; Michal Bloom, Petitioners, v. Merrick B. GARLAND, Attorney General; D. Christopher Evans, in his official capacity as acting Administrator of the U.S. Drug Enforcement Administration; U.S. Drug Enforcement Administration, Respondents.
CourtU.S. Court of Appeals — Ninth Circuit

Matthew C. Zorn (argued), Yetter Coleman LLP, Houston, Texas; Kathryn L. Tucker, Emerge Law Group, Portland, Oregon; James F. Williams and Thomas J. Tobin, Perkins Coie LLP, Seattle, Washington; Andrew J. Kline, Perkins Coie LLP, Denver, Colorado; Holly Martinez, Perkins Coie LLP, Portland, Oregon; Shane Pennington, Vicente Sederberg LLP, New York, New York; for Petitioner.

Thomas Pulham (argued), and Mark B. Stern, Appellate Staff; Brian M. Boynton, Acting Assistant Attorney General; United States Department of Justice, Civil Division, Washington, D.C.; for Respondents.

Peter B. Gonick (argued) and Brendan Selby, Assistant Attorneys General; Robert W. Ferguson, Attorney General; Office of the Attorney General, Olympia, Washington; Mark Brnovich, Attorney General, Phoenix, Arizona; Kathleen Jennings, Attorney General, Wilmington, Delaware; Kwame Raoul, Attorney General, Chicago, Illinois; Dana Nessel, Attorney General, Lansing, Michigan; Keith Ellison, Attorney General, St. Paul, Minnesota; David Yost, Attorney General, Columbus, Ohio; Ellen F. Rosenblum, Attorney General, Salem, Oregon; Karl A. Racine, Attorney General, Washington, D.C.; for Amici Curiae States of Washington, Arizona, Delaware, Illinois, Michigan, Minnesota, Ohio, and Oregon, and District of Columbia.

Christina Sandefur and Timothy Sandefur, Scharf-Norton Center for Constitutional Litigation at the Goldwater Institute, Phoenix, Arizona; Ilya Shapiro and Trevor Burrus, Cato Institute, Washington, D.C.; for Amici Curiae Goldwater Institute and Cato Institute.

David M. Poell, Bradley C. Graveline, and Elizabeth M. Rowe, Sheppard Mullin Richter & Hampton LLP, Chicago, Illinois; Nicholas W. van Aelstyn, Sheppard Mullin Richter & Hampton LLP, San Francisco, California; for Amici Curiae Kathy L. Cerminara, Sylvia Law, Thaddeus Pope, and Rob Schwartz.

Eleanor Hamburger, Sirianni Youtz Spoonemore Hamburger PLLC, Seattle, Washington; Hank Balson, Budge & Heipt PLLC, Seattle, Washington; for Amici Curiae End of Life Washington, EvergreenHealth, The Washington State Psychological Association, A Sacred Passing, and Participating End of Life Care Clinicians and Researchers.

John Wolfe, Orrick Herrington & Sutcliffe LLP, Seattle, Washington; Nicholas Peterson, Orrick Herrington & Sutcliffe LLP, Washington, D.C.; Nancy Talner, American Civil Liberties Union of Washington, Seattle, Washington; for Amicus Curiae American Civil Liberties Union of Washington.

Before: Sandra S. Ikuta, Mark J. Bennett, and Ryan D. Nelson, Circuit Judges.

OPINION

IKUTA, Circuit Judge:

This appeal seeks to challenge a letter sent by the Drug Enforcement Administration (DEA) in response to an attorney's letter seeking advice and guidance on how a physician could administer psilocybin (a hallucinogenic substance) to a terminally ill patient without incurring liability under the Controlled Substances Act (CSA), 21 U.S.C. §§ 801 – 904. Specifically, the letter asked the DEA how the CSA would accommodate the Right to Try Act (RTT Act), 21 U.S.C. § 360bbb-0a, a 2018 enactment which amended the Food, Drug, and Cosmetic Act (FDCA) to give patients the possibility of gaining access to new investigational drugs under certain circumstances. The DEA responded in a letter identifying the available exemptions in the CSA and indicating that the RTT Act did not create any additional exemptions. In this context, we conclude that the DEA's response letter was not "a final decision of the Attorney General," under 21 U.S.C. § 877, and therefore we lack jurisdiction to review it.1

I
A

The purpose of the FDCA is to protect consumers from various risks associated with drugs and biological products. 21 U.S.C. § 393(b)(2) ; see also FDA v. Brown & Williamson Tobacco Corp. , 529 U.S. 120, 133, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000). The FDA enforces the provisions of the FDCA through administrative proceedings, enforcement actions, and civil penalties. 21 U.S.C. §§ 331 – 337a. In general, before a new drug can be introduced into the market, the FDA must approve its new drug application or biologics license application, which must include data from clinical trials. 21 U.S.C. § 355. To get this process started, the sponsor of a clinical trial must submit an investigational new drug (IND) application to the FDA for permission to test the drugs on human subjects. See 21 C.F.R. § 312.2. Sponsors must provide specified information and comply with a long list of requirements to obtain approval of an IND application. See 21 C.F.R. § 312.23. If the application is approved, then the sponsor must embark on three phases of clinical trials. An individual may be able to access an investigational new drug through a clinical trial. 21 C.F.R. § 312.300. But in many cases an individual may be unable to do so if (for example) there is no ongoing clinical trial with that drug, any such trial is full, or the patient does not meet the testing criteria.2 Alternatively, a patient may attempt to access an investigational new drug through the FDA's expanded access program, but manufacturers are often reluctant to provide experimental drugs that may generate adverse event data.3

Because of restrictions on clinical investigations and difficulties associated with the expanded access program, Congress passed the RTT Act in 2018 to give certain patients access to investigational new drugs under certain circumstances, outside of a clinical trial setting. Pub. L. No. 115-176, 132 Stat. 1372 (2018). The RTT Act's primary function is to relieve qualifying individuals from regulatory requirements that would otherwise be imposed on eligible investigational drugs under the FCPA. The Act specifies that it was not intended to "establish a new entitlement" or a "positive right" in any individual. Id. § 3(1).

Under the RTT Act, the patient or physician must apply directly to the sponsor of the IND, and the FDA is not involved in approving or disapproving the patient's access. 21 U.S.C. § 360bbb-0a(d). The RTT Act applies to "[e]ligible investigational drugs provided to eligible patients in compliance with this section" and exempts them from specified statutory and regulatory provisions otherwise applicable to investigational drugs. Id. § 360bbb-0a(b).4 An "eligible investigational drug" is an investigational drug that meets several criteria. Id. § 360bbb-0a(a)(2). An "eligible patient" is someone who has been diagnosed with a "life-threatening disease or condition," has "exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug" (as certified by a physician), and has provided written informed consent regarding the drug. Id. § 360bbb-0a(a)(1). Under the RTT Act, the sponsor of the drug is responsible for ensuring that the applicable criteria are met. See id. § 360bbb-0a(b).

The purpose of the CSA, 21 U.S.C. §§ 801 – 904, is to prevent the misuse of substances that threaten public health and welfare. See 21 U.S.C. § 801(1). To this end, the CSA makes it a crime to manufacture, distribute, or possess a controlled substance without authorization. 21 U.S.C. §§ 841(a)(1), 844(a). A "controlled substance" is defined as "a drug or other substance, or immediate precursor" included in a schedule established by the CSA. 21 U.S.C. § 802(6) (citing schedules defined by part B of the CSA, 21 U.S.C. § 811 – 814 ). The CSA categorizes controlled substances into five schedules based on safety, accepted medical use, and potential for abuse. Id. § 812(b). Schedule I drugs have "a high potential for abuse," "no currently accepted medical use in treatment in the United States," and "a lack of accepted safety for use ... under medical supervision." Id. § 812(b)(1). Psilocybin is a hallucinogenic substance obtained from certain mushrooms, and is a Schedule I drug under the CSA. Id. § 812, Schedule I(c)(15).

Controlled substances may be used lawfully under limited circumstances. A person registered with the Attorney General may dispense controlled substances "to the extent authorized by their registration and in conformity with the other provisions of" the CSA. Id. § 822(b).5 Because substances in Schedule I are deemed to have no accepted medical use under the CSA, they can be produced, dispensed or possessed only in the context of research, and this research requires a special registration. Id. § 823(f); see also 21 C.F.R. §§ 1301.18, 1301.32. If an individual is registered as an approved researcher in controlled substances, the researcher is exempt from prosecution under federal, state, or local laws when acting within the scope of his registration "for offenses relating to possession, distribution or dispensing of those controlled substances within the scope of his exemption." 21 C.F.R. § 1316.24(a). The DEA is responsible for enforcing the registration requirements of the CSA. 28 C.F.R. § 0.100(a).

Any person or organization that produces or distributes prescription drugs that are also controlled substances must comply with the requirements of both the FDCA and the CSA.6

B

Dr. Sunil Aggarwal is co-director of the Advanced Integrative Medical Science Institute (AIMS) in Seattle, Washington. In January 2021, Kathryn Tucker, counsel to AIMS and Dr. Aggarwal, wrote a letter to the DEA Regulatory Section, stating that Dr. Aggarwal was registered by the DEA to prescribe controlled substances, and sought "additional registration" pursuant to the RTT Act "to obtain psilocybin, a Schedule I drug, for therapeutic use with...

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3 cases
  • Arizona Yage Assembly v. Garland
    • United States
    • U.S. District Court — District of Arizona
    • March 30, 2022
    ...Section 877 applies only to "final decision[s] of the Attorney General."10 See 21 U.S.C. § 877 ; Advanced Integrative Med. Sci. Inst., PLLC v. Garland , 24 F.4th 1249, 1252 (9th Cir. 2022). The Federal Defendants argue that the decision to promulgate the Guidance constituted a final decisio......
  • Ariz. Yage Assembly v. Garland
    • United States
    • U.S. District Court — District of Arizona
    • March 30, 2022
    ...seeking a CSA exemption-there has been no decision of the Attorney General that could trigger § 877's jurisdictional limitation. Cf. Id. at 1260 a letter sent by the DEA that “did not grant or deny any request, nor impose any legal consequence” did not constitute a final decision of the Att......
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    • U.S. District Court — District of Montana
    • December 1, 2023
    ... ... asserting jurisdiction.” Advanced Integrative Med ... Sci. Inst., PLLC v ... ...

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