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The Drug Enforcement Administration (DEA) is arguing that a federal law giving seriously ill people the “right to try” investigational drugs doesn’t apply to controlled substances like psychedelics. The agency’s claim comes in a new brief in a lawsuit filed by a Washington State doctor seeking to legally use psilocybin to treat cancer patients in end-of-life care.
“Because substances in Schedule I are deemed to have no accepted medical use in under the CSA,” DEA contends, referring to the federal Controlled Substances Act (CSA), “the law does not provide for any registration that would permit such drugs to be dispensed in the course of professional practice.”
DEA filed the brief late last week in U.S. Circuit Court of Appeals for the Ninth Circuit, in response to the latest legal challenge from Dr. Sunil Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute. Aggarwal and AIMS have spent years pursuing various legal and regulatory pathways to allow the clinic to use psilocybin in palliative care.
The clinic generally argues that the CSA must accommodate a path to legally accessing psilocybin under state and federal right to try (RTT) laws, which are intended to give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use.
Washington State adopted a right to try law in 2017, and then-President Donald Trump (R) signed the federal Right to Try Act the following year. Dozens of other states have also enacted right to try policies.
In the years since, AIMS has presented DEA with multiple proposals in order either to legally cultivate or otherwise obtain psilocybin to treat patients under RTT. The agency has denied them all.
“DEA has rejected each request,” the clinic argued in its opening brief earlier this year, “but has never addressed the arguments that Dr. Aggarwal has raised in support of them.”
“If DEA wants to disclaim authority to grant Dr. Aggarwal access to psilocybin under the CSA and RTT,” AIMS contined, “it must provide a reasoned explanation for how that decision comports with the CSA and the agency’s own precedent.”
Eight U.S. states as well as Washington, D.C. have filed a friend of the court brief in support of AIMS’s effort to use psilocybin under state and federal RTT laws.
But in its response this week, DEA asserts that the federal RTT Act doesn’t affect CSA’s prohibition of certain drugs.
“The Right to Try Act does not provide anyone with a right to dispense or receive controlled substances,” the new brief says. Rather, the primary function of the federal law was “to relieve qualifying individuals from regulatory requirements that would otherwise be imposed on eligible investigational drugs under the” federal Food, Drug and Cosmetics Act (FDCA), DEA argues.
“As DEA explained, the Right to Try Act does not ‘provide any exemptions from the CSA or its implementing regulations. And it does not ‘give the DEA authority to waive CSA requirements,’” the government’s brief says. “Indeed, the Right to Try Act does not even mention the CSA or controlled substances at all.”
If Aggarwal wants to give psilocybin to patients, DEA contends he would need to be a registered researcher conducting an approved project—which DEA says are matters handled by different federal agencies.
“The only registration that would permit a physician to dispense a schedule I controlled substance is registration as a researcher conducting an approved research project,” its brief says. “DEA cannot issue such a registration unless the Secretary of Health and Human Services, acting through FDA, determines that the research protocol is meritorious and the applicant is qualified and competent to conduct it.”
DEA’s brief criticizes the AIMS lawsuit’s interpretation of the law as “a fundamental misunderstanding” and “a tortuous account of the interaction between the two statutes”—RTT and FDCA. Such a reading, it says, “would vest authority in DEA to allow physicians to provide patients with schedule I substances for therapeutic purposes, notwithstanding Congress’s determination that the drugs lack accepted medical use or safety under medical supervision.”
“Petitioners’ posited tensions between the CSA and the FDCA are without basis,” the agency’s brief says. “While the subject matter of the two statutes overlaps somewhat (because they both deal with drugs), each statute establishes its own requirements and prohibitions, and DEA and FDA have complementary spheres of authority… But that does not mean that one agency has superseded or interfered with the other’s statutory regime.”
A 2022 amendment to the federal RTT Act created a separate registration process to facilitate cannabis research, DEA noted in its brief, but “this new process still requires that new research projects be ‘reviewed and allowed…by the Secretary of Health and Human Services.’”
“Thus,” the filing says, “even when Congress has acted specifically to enhance research of a Schedule I drug, it has made researcher registration conditional on approval by the Secretary.”
Shortly after the lawsuit was filed, Washington State and eight other jurisdictions—Delaware, Illinois, Michigan, Minnesota, Nevada, Oregon, Pennsylvania and Washington, D.C.—filed an amicus brief in support of the clinic’s position, arguing that CSA doesn’t prohibit the use of controlled substances under RTT. Many of the same states filed an amicus brief in a related 2021 case involving Aggarwal.
“The CSA was intended to combat drug trafficking and abuse,” says the latest filing, led by the office of Washington State Attorney General Bob Ferguson (D).
“It is easy to make sense of both the CSA and the later, more specific RTT Act,” it suggests: “neither law facilitates traffic in illicit substances, both laws emphasize the primacy of states in the regulation of medical practice, and the RTT Act includes broad immunity from liability.”
“It is irrelevant whether a Schedule I substance has a ‘currently accepted medical use’ under the CSA in the context of uses authorized by the RTT Act,” the states’ brief says. “The RTT Act’s purpose is to provide a unique, targeted exemption from such requirements.”
Aggarwal and AIMS have been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care, initially seeking to win permission from regulators under state and federal RTT laws.
When DEA rebuffed that request, Aggarwal sued. But in early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action.
The current Ninth Circuit cases stems from Aggarwal’s responses to that ruling. In February 2022, the doctor filed a formal petition with DEA to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA)—the denial of which is a reviewable action. He also applied for the regulatory waiver to obtain psilocybin.
DEA denied Aggarwal’s petition in September 2022 and rejected the waiver request the next month. The doctor’s Ninth Circuit cases challenge both decisions.
As Aggarwal’s efforts have made its way through the courts, a number of studies have strengthened the case for psilocybin’s legitimate medical use. In response, Congress late last year sent a defense bill to President Joe Biden (D) that contains provisions to fund studies into the therapeutic use of psychedelics such as psilocybin and MDMA for military service members.
A recent clinical trial published by the American Medical Association, meanwhile, found that psilocybin “displayed strong and persistent antidepressant effects” in people with bipolar II disorder, “with no signal of worsening mood instability or increased suicidality.”
In September of last year, researchers at Johns Hopkins and Ohio State universities published a report that linked psilocybin use with “persisting reductions” in depression, anxiety and alcohol misuse, as well as increases in emotional regulation, spiritual wellbeing and extraversion.
Those results were “highly consistent with a growing body of clinical trial, behavioral pharmacology, and epidemiological data on psilocybin,” authors of the study said. “Overall, these data provide an important window into the current resurgence of public interest in classic psychedelics and the outcomes of contemporaneous increases in naturalistic psilocybin use.”
Last August, a separate study from the American Medical Association (AMA) found that people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin.
And a survey by Canadian researchers published in October said psilocybin use can help ease psychological distress in people who had adverse experiences as children. Researchers said psilocybin appeared to offer “particularly strong benefits to those with more severe childhood adversity.”
Canada, for its part, allowed four cancer patients in 2020 to become the nation’s first people in decades to legally possess psilocybin after being granted permission by the country’s health minister to use the substance for end-of-life care. Later that year, some healthcare professionals also gained the ability to legally possess and use psilocybin themselves.
A survey published earlier this year found that roughly 8 in 10 Canadians believe psilocybin is “a reasonable choice” for end-of-life care.
Read the DEA response brief in AIMS v. DEA below:
Second California Senate Committee Approves Bill To Legalize Psychedelic Service Centers
Photo courtesy of Wikimedia/Workman.
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