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Judy Huth met Bill Cosby when she was still a teenager, she has recounted in court papers. It was the mid-1970s, and Mr. Cosby had already had his breakthrough on the TV series I Spy and become a movie star, but was still years away from his huge success on The Cosby Show. Ms. Huth and a friend spotted him on a film set in a park in San Marino, Calif., and ended up meeting him in person, according to her court filings.

Days later, she asserts in the filings, she went to Mr. Cosbys tennis club at his invitation, where he gave her and her friend alcohol before taking them to the Playboy Mansion in Los Angeles, where she accuses him of forcing her to perform a sex act on him in a bedroom. Mr. Cosby has described her account as a fabrication since the case was first filed in 2014.

This week the job of deciding who is credible will fall to a jury in Los Angeles Superior Court, as the civil trial of Mr. Cosby on Ms. Huths accusations that he sexually assaulted her is scheduled to get underway.

Ms. Huths recollection regarding when the encounter occurred has changed. She initially said that it had happened in 1974, when she was 15. But more recently she concluded that it was actually in 1975, when she was 16, according to court papers. Since the beginning, she has said in court papers that she recalled Mr. Cosby telling her and her friend to claim they were both 19 if asked at the mansion.

The change of dates has led Mr. Cosbys team to further dispute her account. Andrew Wyatt, a spokesman for Mr. Cosby, said in a statement that Ms. Huth had made inconsistent statements since the inception of filing this civil suit against Mr. Cosby. Ms. Huth has said that recently released information supplied by Mr. Cosbys team had led her to reconsider what year it occurred.

The civil case, one of the last unsettled lawsuits against Mr. Cosby, was largely put on hold while prosecutors in Pennsylvania pursued the criminal case that resulted in his 2018 conviction on charges of drugging and sexually assaulting Andrea Constand. But the conviction was overturned, and Mr. Cosby was released from prison last year when an appellate panel found that his due process rights had been violated when prosecutors ignored an assurance from a prior district attorney that Mr. Cosby would not be prosecuted.

With the criminal case overturned, the significance of Ms. Huths suit has risen in the minds of some of the many women who have accused Mr. Cosby of being a sexual predator.

I think that Judys trial may be our last stand for justice and seeing accountability come to fruition in our stand against Bill Cosby, Victoria Valentino, who says Mr. Cosby drugged and raped her in Los Angeles in 1969, said in a text. (Mr. Cosby has denied all allegations of sexual assault, and said any encounters were consensual.) She said she plans to attend part of the trial, which, barring a last-minute settlement, is set to begin with jury selection this week and opening arguments expected June 1.

Patricia Steuer, who accused Mr. Cosby of drugging and assaulting her in 1978 and 1980, said that she saw the Huth civil trial as a chance to get a measure of justice. There is no other recourse at the moment, she said. It probably is the only avenue available.

Mr. Cosby, now 84, has already faced multiple other civil cases filed against him by women, many of whom sued him for defamation after his legal team dismissed as fictions their accusations of sexual misconduct by him. Eleven civil cases ended in settlements, with 10 of the settlements having been agreed to by Mr. Cosbys former insurance company over his objections, according to his spokesman.

Ms. Huths lawsuit is poised to become the first civil case accusing Mr. Cosby of sexual assault to reach trial. In court papers, Ms. Huth says that in a bedroom at the Playboy Mansion, Mr. Cosby tried to put his hand down her pants and then forced her to fondle him.

Ms. Huth filed her suit in December 2014, at a time when Mr. Cosby was facing allegations by many women who said he had drugged and sexually assaulted them, in incidents spanning several decades.

She also reported her accusation to the police, but the Los Angeles County District Attorneys Office declined to file criminal charges because the statute of limitations had passed.

Her lawyers argued that the period for a civil claim had not expired, however, because in California it is extended for adults who say they were victims of sexual abuse as minors but repressed the experience. The deadline to file such a suit is determined in part by when the person, as an adult, becomes aware of the severe psychological effect of the abuse, her lawyers said.

In 2020, California law was amended to further extend the statute of limitations for sexual assault filings in civil court.

Ms. Huths revised timeline, which says Mr. Cosby assaulted her when she was 16 rather than 15, should not affect her ability to pursue the suit since the law views a 16-year-old as a minor, Ms. Huths lawyer, Gloria Allred, said.

Mr. Cosbys lawyers argued in legal papers that they felt ambushed by the sudden change in Ms. Huths account. They said that their research had been geared toward establishing Mr. Cosbys and Ms. Huths whereabouts in 1974, and said they had prepared evidence to show that the entertainer was not at the Playboy Mansion in the period she suggested in 1974.

Log books from the Playboy Mansion for 1974 do not list either Ms. Huth or her friend as having visited, according to Mr. Cosbys lawyers.

At a hearing last week, the judge asked Playboy to produce records for 1975 and agreed that Ms. Huth and the friend who accompanied her should sit for a further deposition before the trial begins.

Mr. Cosbys lawyers have also questioned whether she had only remembered the alleged abuse a short time before filing the suit because, they said, she had contacted a tabloid about it 10 years earlier.

Mr. Wyatt, the spokesman for Mr. Cosby, said in the statement, We feel confident that the Playboy records along with Ms. Huth changing her timeline of events from 1974 to 1975 in the 11th hour will vindicate Mr. Cosby.

Mr. Cosby acknowledged meeting with Ms. Huth at the Playboy Mansion, and Ms. Huth has produced photographs of them together that she said were taken there, according to court papers. But he has denied that she was a minor when they met.

While defendant does not deny that he socialized with plaintiff at the Playboy Mansion, as he did other women and men who frequented the club, his lawyers said in court papers, defendant vehemently denies that plaintiff was underage.

Ms. Huth has said that she changed the timeline of her account in part because she only recently realized, as a result of documents put forward by Mr. Cosby, that the filming of the movie Lets Do It Again, where she says they met, took place later than she had recalled.

The trial is expected to last two weeks, and Ms. Huth, who is seeking damages from Mr. Cosby, is expected to testify, along with the friend who accompanied her to the Playboy Mansion. Mr. Cosby has invoked his Fifth Amendment privilege against self-incrimination and will not testify. He will not attend the trial, Mr. Wyatt said.

During pretrial hearings, Ms. Huth had asked for a bench trial, but the trial will be in front of a 12-person jury, with at least 9 of 12 votes needed for a verdict.

Mr. Cosby settled a civil case Ms. Constand brought against him in 2006 for $3.4 million. The other civil cases were settled for undisclosed terms by the insurance carried on Mr. Cosbys home policy, which provided personal injury coverage in a range of circumstances, including lawsuits that accused the policy holder of defamation.

The other ongoing civil case against Mr. Cosby was filed last year by Lili Bernard, an actor and visual artist, who accused him of drugging and sexually assaulting her at a hotel in Atlantic City in 1990, when she was 26. She was able to file the suit, which is still in its early stages, because in 2019 New Jersey overhauled its laws on the statute of limitations for sexual assault cases, extending the time limit for filing suits and creating a special two-year window allowing people to bring cases regardless of how long ago the alleged assaults might have occurred.

Original post:
Lawsuit Accusing Bill Cosby of Sexual Assault Heads to Trial - The New York Times

MARY REICHARD, HOST:Good morning!

Police officers must read your Miranda rights to you if they intend to interrogate you. But what are the limits to asserting that right?

NICK EICHER, HOST:Thats ahead on Legal Docket.

Also today the Monday Moneybeat, well talk about a stock market that is on the brink of a bear market.

Plus the WORLD History Book. 25 years ago this week, a pilot completes Amelia Earharts journey.

REICHARD:Its Monday, May 23rd. This is The World and Everything in It from listener-supported WORLD Radio. Im Mary Reichard.

EICHER:And Im Nick Eicher. Good morning!

REICHARD:Up next, Kent Covington with todays news.

KENT COVINGTON, NEWS ANCHOR:U.S. military flies emergency baby formula supplies from Europe U.S. Military planes usually carry emergency supplies out of the country to other nations in need, but this time, its the other way around.

A cargo plane carrying baby formula from Germany arrived in Indianapolis on Sunday.

Secretary of Agriculture Tom Vilsack:

VILSACK: The reason why we are doing this is obviously the critical need that is out there. It would take approximately two weeks for the normal commercial process to work. As a result of the United States militarys involvement, were going to get this here in a matter of days.

The C-17 cargo plane carried enough formula to fill more than a half-million bottles. The flight brought 15 percent of the specialty medical grade formula needed in the United States.

It was the first of several flights expected from Europe aimed at easing the nationwide formula shortage.

Brian Deese, director of the White House National Economic Council said people should see more formula in stores starting as early as this week.

Contamination forced a shutdown of the nations largest baby formula plant. That has fueled much of the nations shortage.

Biden wraps up South Korea trip, plans to announce economic plan in Japan President Biden wrapped up a visit to South Korea on Sunday. In remarks at Osan Air Base, Biden told service members monitoring the North Korean nuclear threat

BIDEN: You are on the front line of everything were concerned about. You represent the commitment [that] our two countries made to each other and the strength of the U.S.-ROK alliance.

He wrapped up his three-day trip to South Korea by showcasing Hyundai's pledge to invest at least $10 billion in the United States.

BIDEN: The new facility should be rolling out the latest electric vehicles and batteries to power them by 2025.

He said that will create thousands of jobs in the state of Georgia.

This morning, the president is in Japan where hes planning to announce an economic plan to counter Beijing in the Indo-Pacific region.

President Biden approves Ukraine aid While in South Korea over the weekend, President Biden signed into law a massive new aid package for Ukraine. WORLDs Josh Schumacher has more.

JOSH SCHUMACHER, REPORTER: The legislation passed Congress with big bipartisan majorities. It will provide $40 billion in military and economic aid.

It is intended to support Ukraine through September, and it dwarfs an earlier emergency measure that granted roughly thirteen-and-a-half billion.

The new legislation provides $20 billion in military assistance. That will ensure that advanced weapons continue to flow to Ukraine to help blunt Russias advances.

It also gives a billion dollars to help refugees$8 billion in economic support and $5 billion to fight global food shortages brought on by Russias invasion.

Reporting for WORLD, Im Josh Schumacher.

W.H.O. chief: The pandemic isnt over The head of the World Health Organization, Tedros Ghebreyesus, warned on Sunday that were nowhere near being out of the woods with COVID-19.

GHEBREYESUS: No, its most certainly not over. I know thats not the message you want to hear, and its definitely not the message I want to deliver.

He said cases are now on the rise in almost 70 countries in all regions, and this is in a world in which testing rates have plummeted.

He added that this virus has surprised us at every turn.

GHEBREYESUS: A storm that has torn though communities again and again, and we still cant predict its path or its intensity.

Cases continue to rise in the United States. Thats been the case for nearly two months now. That increase has been somewhat slow and steadynothing like the huge omicron spike in December and January.

Still, U.S. cases have more than tripled since Marchfrom about 29,000 infections per day to nearly 100,000 per day. But deaths have continued to slowly decline.

White House virus response coordinator Dr. Ashish Jha told ABCs This Weekthat Congress must step up with more pandemic funding now.

JHA: If they dont, we will go into the fall and winter without that next generation of vaccines, without treatments and diagnostics. Thats going to make it much, much harder for us to take care of and protect Americans.

Jha also recommended Americans continue toor return towearing masks indoors in public.

Im Kent Covington.Straight ahead: a Supreme Court oral argument lightning round.

Plus, a rock-n-roll hit makes its debut.

This is The World and Everything in It.

MARY REICHARD, HOST:Its Monday, May 23rd and youre listening to The World and Everything in It from WORLD Radio. Good morning! Im Mary Reichard.

NICK EICHER, HOST:And Im Nick Eicher. Its time for Legal Docket.

The current Supreme Court term ends next month and that means a slew of opinions will be handed down between now and then. Big issues like abortion, gun rights, and prayer still to be decided.

Last week, two opinions came down.

The first one is a win for a sitting United States senator. Ted Cruz of Texas challenged an aspect of the campaign finance law known as McCain-Feingold. That law capped the amount of personal loan money candidates can reimburse themselves using funds collected after election day.

A 6-3 decision said that rule violates the right to free speech. But the liberal justices criticized the majority opinionfor in their view ignoring the intent of the law which is to curb corruption.

Over the years, a few other provisions of McCain-Feingold already have been struck down as unconstitutional.

REICHARD:The second decision concerns immigration. A 5-4 ruling says regular courts cannot review factual findings made by judges in immigration courts.

This is bad news for a man from India in the United States for 30 years under a work visa. He didnt go through the formal inspection process when he arrived in 1992. And he checked a box on an application for a drivers license in 2008 that said US citizen when he was not.

Those things triggered deportation proceedings. The majority justices found such facts are not reviewable by a court.

EICHER:Okay, on to oral arguments.

Hang on to your seats, though, because we will hit highlights in five cases today, but within our usual time constraints. Were going to go fast, so here we go:

Dispute Number One relates to the 1966 Supreme Court decision that gave us whats been known ever since as Miranda rights. That ruling required police to advise suspects of their right to remain silent while in police custody and to obtain a lawyer before theyre interrogated.

Lets flash back to February 1966. Heres lawyer John Flynn. He represented Ernesto Miranda:

FLYNN:I believe the record indicates that at no time during the interrogation and prior to his oral confession was he advised either of his rights to remain silent, his right to counsel, or of his right to consult with counsel; nor, indeed, was such the practice in Arizona at that time, as admitted by the officers in their testimony. The defendant was then asked to sign a confession, to which he agreed.

A split court agreed that procedural safeguards are necessary to protect Fifth Amendment rights; people should be advised of their rights in order to assert those rights.

Fast forward 56 years to the question before the high court now: Just how far does Miranda go?

The facts are straightforward. Terence Tekoh worked at a medical facility in Los Angeles. Police officer Carlos Vega arrested him on suspicion of sexual assault of a patientbut Officer Vega didnt issue Tekoh his Miranda rights.

Later on, a jury acquitted Tekoh of sexual assault.

Case closed? Not quite.

Tekoh then sued Vega for that failure to issue Miranda rights to him.

But is that failure by itself a sufficient basis for a federal lawsuit?

EICHER:It is notto hear the lawyer for the federal government argue. Have a listen to this exchange between Assistant to the Solicitor General Vivek Suri and a more skeptical Justice Clarence Thomas.

SURI:Miranda recognized a constitutional right, but it's a trial right concerning the exclusion of evidence at a criminal trial. It isn't a substantive right to receive the Miranda warnings themselves. A police officer who fails to provide the Miranda warnings accordingly doesn't himself violate the constitutional right, and he also isn't legally responsible for any violation that might occur later at the trial. The Ninth Circuit's contrary decision should be reversed.

THOMAS:What if the police officer purposely lies in order to convince the prosecutor to use the statement?

SURI:We would still say that there is no Miranda claim, but I have to be clear that that issue is not properly presented in this case.

REICHARD:What stood out to me in this and several other arguments this term are comments from the justices about the role of the Supreme Court.

Listen to Justice Elena Kagan address the attorney for the police officer. She refers to what Miranda and subsequent case law has come to mean to Americans.

KAGAN:that it, you know, was sort of central to people's understanding of the law and that if you overturned it or undermined it or denigrated it, it would be -- you know, it had -- would have a kind of unsettling effect not only on people's understanding of the criminal justice system but on people's understanding of the Court itself and the legitimacy of the Court and the way the Court operates and the way the Court sticks to what it says, you know, not just in a kind of technical stare decisis sense but in a more profound sense about the Court as an institution and the role it plays in society.

Alright, cases two and three both involve questions of procedure.

In one case, a man convicted of drug and firearm offenses appealed and lost. Then he tried to have the sentence vacated on the basis that he had a lousy lawyer.

But the crux of this case is based upon whether the judge was lousy, too: specifically, a mistake by the judge who found that the man missed a filing deadline, but in fact he really didnt miss it.

So now the question is whether the Federal Rules of Civil Procedure allow courts to fix that problem.

Sounds straightforward. But it isnt.

Listen to Justice Amy Coney Barrett opine that maybe both sides have this wrong.

BARRETT:You have the difficulty of distinguishing between fact and law, and then you also have the difficulty in identifying whose error was it? I mean, I think the government makes a good point, that it can be difficult to figure out if a legal error was by the litigant or by the court.It could be categorized as the counsels error. It could be categorized as the courts error.

Justice Stephen Breyer acknowledged human error.

BREYER:Look, the judges do make mistakes. Give them a quick chance to do it, even if its one of law. Call it to their attention. Six of one, half dozen of the other because we have problems both ways.

The other procedural dispute involves two companies fighting over alleged fraud in a business transaction. Theyd each signed an arbitration agreement to settle problems before an arbitration board in Germany.

But before arbitration can proceed, one company seeks discovery, that is, relevant documents and testimony, and wants a federal district court to compel the other party to provide it.

The question is whether federal district courts even have authority to make such an order.

Justice Kagan doubted one sides interpretation of the law:

KAGAN:I mean, it all depends, right? And I guess my broader question is, like, really, what can you take from this language? I'm all for, you know, being serious about language when there's something to be serious about, but I don't know

On to our fourth argument, a case captioned United States v Washington.

This one asks how state laws around workers compensation apply when federal contractors are involved.

Heres the situation. The Department of Energy oversees cleanup of a nuclear waste site in the state of Washington. Its expected to take 60 years! Some of those doing the work are federal contractors.

An old state law presumes health problems like cancer and lung disease will occur as a result of doing this kind of work. The law says thatll trigger workers compensation benefits. The federal government contests that aspect.

After the Supreme Court took the case, Washington state changed that law, so now theres an additional question of whether the case is now moot.

This dispute involves a doctrine called intergovernmental immunity. That prevents the federal government and state governments from intruding on each others sovereignty.

Lawyer for the state of Washington argued all this doesnt matter anymore because the new law resolves the old problems.

But Justice Breyer wasnt so sure about that.

BREYER:if its a real problem, then I cant say its moot.

OK, fifth and final argument today, this one about Chapter 11 bankruptcy and quirky laws governing bankruptcy in Alabama and North Carolina.

Those two states oversee corporate bankruptcies by the Judicial Conference and leave the appointment of trustees to handle the cases to the bankruptcy judges.

Thats different from the rest of the country. The US Trustees Office oversees Chapter 11 proceedings for the 48 other states.

Therere reasons for that. Too in the weeds for our purposes here, so Ill spare you.

This is the point, though: The law requires payment to Trustees to come from the debtors estate.

A few years ago, Congress raised those fees up to $250,000. But that fee increase didnt apply to Alabama and North Carolina.

Chief Justice John Roberts:

See the original post:
The World and Everything in It - May 23, 2022 - WORLD News Group

This article by Natasha Sumner was originally published on Microdose and appears here with permission.

A growing body of research into the therapeutic use of psychedelics, including MDMA, psilocybin, LSD, ketamine, and DMT, are delivering promising results to treat a wide range of conditions such as post-traumatic stress disorder (PTSD), depression, end-of-life anxiety, eating disorders, stroke, and chronic pain. Robin Carhart-Harris, head of theCentre for Psychedelic Researchat Imperial College London,wrote forThe Guardian, we can no longer ignore the potential of psychedelic drugspsychedelics appear to increase brain plasticity, which, broadly speaking, implies an accelerated ability to change.

This article provides a brief overview of the Food and Drug Administrations (FDA) regulatory scheme around drug development, future clinical research of psychedelics, andlegal challenges in this emerging area.

The FDA regulates all drugs sold in the United States, which includes research pertaining to psychedelics. Typically, once a new molecule has been screened for pharmacological activity and acute toxicity potential in animals, the FDAs role begins and the legal status of the molecule changes to a new drug subject to specific regulatory requirements. The Multidisciplinary Association for Psychedelic Studies (MAPS) conducted Phase 2 clinical trials from 2004 to 2017 studying the effects of MDMA on PTSD.[1] Six randomized, double-blind, controlled clinical trials at five study sites were conducted. Active doses of MDMA (75125mg) or placebo/control doses (040mg) were administered to individuals with PTSD during psychotherapy sessions in two or three eight-hour sessions spaced a month apart. Three non-drug 90-minute therapy sessions preceded the first MDMA exposure, and three to four followed each experimental session. After two blinded experimental sessions, the active group had significantly greater reductions in CAPS-IV[2]total scores from baseline than the control group. Depression symptom improvement was greatest for the active group compared to the control group.

In May 2021, MAPS released the results of its Phase 3 trial.[3] MDMA-assisted therapy reported a significant reduction in PTSD symptoms compared to those who received placebo with therapy. This is thefirst Phase 3 trial of any psychedelic-assistedtherapy.These are incredibly important findings because although SSRIs are associated with an overall response rate of approximately 60% in patients with PTSD, only 20% to 30% of patients achieve complete remission.[4]

In aPhase 2 study comparing psilocybin to an SSRI, the psilocybin group did not show a statistically significant difference in Quick Inventory of Depressive Symptomatology-Self-Report scores compared with the SSRI after six weeks. However, the psilocybin group showed significantly larger reductions in suicidality, anhedonia, and standard psychological scores for depression. In November 2021,COMPASSPathway completeda phase IIb clinical trial on psilocybin and depression that demonstrateda highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with a rapid and durable treatment response.

In 2016,Johns Hopkins conducted a small double-blind studylooking at the effects of psilocybin on end-of-life anxiety. Researchers reported that a substantial majority of people suffering cancer-related anxiety ordepressionfound considerable relief for up to six months from a single large dose of psilocybin.

The FDA has numerous expedited processes that are designed to speed up the development and review of drugs that are intended to treat a serious condition and psychedelics are no exception to receiving such designations.The first psychedelic drug to gain FDA Breakthrough Therapy designation wasJohnson & Johnsons esketamine nasal sprayfor treatment-resistant depressionin 2013 and then again in 2016.MDMA was designated as Breakthrough Therapy in 2017 for PTSDandpsilocybin in 2018 for treatment resistant depression.

In addition to these expedited programs, the FDA has an expanded access program, sometimes called compassionate use, which is a potential pathway for a patient with animmediately life-threatening condition or serious disease or conditionto gain access to aninvestigational medical productfor treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.TheRight to Try Actis another way for patients diagnosed with life-threatening diseases who have exhausted all approved treatment options and are unable to participate in aclinical trialto gain access to certain unapproved treatments. However, the Schedule 1 status of psychedelics has been a hurdle to terminally ill patients being provided with these drugs.

The psychedelic arena has also sought orphan drug status. In February 2021, PharmaDrug Inc., a pharmaceutical company focused on the research, development and commercialization of controlled-substances, natural medicines such as psychedelics, cannabis and naturally-derived approved drugsfiled an application with theFDA to receiveOrphan Drug Designationfor N,N-Dimethyltryptamine (DMT)in the treatment of acute ischemic stroke patients presenting for emergency medical assistance within 3-hours of symptom onset and for the prevention of ischemia reperfusion injury in patients undergoing kidney transplantation. An orphan drug designation allows for seven years of market exclusivity, a great incentive to find treatments for rare diseases or conditions.

FDA-approved clinical trials are key to psychedelics being approved for use in mental health and other treatments. Below is a list of current and upcoming psychedelic research:

There are numerous issues that have and will arise in the context of clinical research and drug development of psychedelics such as findinga source of a Schedule 1 drug that will pass regulatorymuster.In addition to regulating importation of drugs, the Drug Enforcement Agency (DEA) restricts who and howa researcher can study Schedule 1drugs. Furthermore, there are difficulties inusinga placebofor biascontrol in a psychedelic trial because of the strong physical and psychological effects these drugs have; in other words, both the participant and the researcher would know whether or not the participant was given the active compound versus the placebo.

Because clinical trials are showing high efficacy and safety, at least in certain settings, some of the psychedelic drugs may be rescheduled in the near future. That may create issues with exclusivity periods. When the DEA seeks toschedulea new drug under the Controlled Substances Act, itmust request recommendations from theFDA. Because theFDArequires applicants for approval of new drugs to commit not to market those drugs until after the DEA makes itsschedulingdetermination, theschedulingprocess can delay the entry of new drugs into the market, sometimes by more than a year after theirFDAapproval. The central issue inEisai, Inc. v. United States Food and Drug Administration(US Dist. Ct, D.C., 2015) waswhether and under what circumstances the period of time drug manufacturers spend waiting for a final DEAschedulingdetermination counts against the five-year exclusivity period.[5]

Because many psychedelic research companies are located outside of the Unites States,John Doe v. DEA(2017) is an interesting and relevant case addressing importation and bioequivalence in the context of generic drug approval. A drug manufacturer wanted to market a generic version of the drugMarinol, an FDA-approved drug containing the same active ingredient as marijuana and used to treat nausea and loss of appetite incancerand AIDS patients. To get approval to market its generic alternative, the plaintiff was required to successfully complete bioequivalency studies.Id. At 563. The FDA, after extensive testing and research, approvedMarinoldescribing it as [d]ronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsulefor treatment of nausea associated withcancerpatients and anorexia associated with weight loss in AIDS patients.Id. At 564. The DEA eventually assigned dronabinol(synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product to schedule III.Ibid. All other mixtures, compounds and preparations containingdronabinolremain[ed] in Schedule I.Ibid. In practical effect, only the brand name drug Marinol was rescheduled.Ibid.

The plaintiff sought to import over half a million capsules of its drug from its overseas manufacturing partner.Id. at 563. When the DEA learned that the substance plaintiff sought to import was notMarinol, the DEA denied plaintiffs permit application.Id. At 564. Because plaintiffs drug containing dronabinol has not been approved for marketing by the FDA, the DEA classified the drug as falling within the general category of dronabinol in schedule I, not schedule IIIs narrow description of [d]ronabinol in a U.S. Food and Drug Administration approved product.21 C.F.R. 1308.13(g)(1)(emphasis added).Ibid. Thus, the plaintiff found itself in a catch22: while it sought to import its drug under schedule III so it could conduct testing necessary to obtain FDA approval, the DEAs interpretation of its regulatory provision effectively prohibits importation of a drug containing dronabinol under schedule III until the drug is FDA approved. Ibid. The DEA interpreted its schedule III regulatory languageDronabinol(synthetic)in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product,21 C.F.R. 1308.13(g)(1)as not encompassing Does dronabinol drug, because plaintiffs drug is not FDA approved for marketing.Id. at 570-71. The plaintiff argued that this interpretation was contrary to law, arbitrary and capricious, and violated the due process clause of the Fifth Amendment.Ibid.In disagreeing with plaintiff, the court noted that plaintiff had options: (1) petition to have its dronabinol drug rescheduled, or (2) obtaining schedule I registration.Id. at 573. The court also noted that it was not unsympathetic to plaintiffs predicament. The DEAs interpretation obviously does make it harder (and costlier) for plaintiff to obtain final FDA approval to market its generic drug. As plaintiff has pointed out, this result runs counter to Congresss purpose manifested in the so-called HatchWaxman Amendments,Pub. L. No. 98417, 98 Stat. 1585 (1984), to make available more low cost generic drugs.Ibid. (citations omitted). The court concluded by noting that to the extent the DEAs interpretation is bad policy, that must be addressed by the agency or Congress.Ibid

A sign that the federal government is changing its purview of psychedelics is theMay 2021 DEA decisionto allow Wake Network to legally import psilocybin for research. Furthermore, theDEA recently increased the legal production quotasof MDMA, DMT, and psilocybin for use in research.

The importance of these cases and recent DEA actions to the area of medicinal use of psychedelics is manifold. The courts decision inJohn Doeeffectively meant that Marinol would have a much longer hold on the market absent any competition from a generic version. Additionally, the cases referenced above illustrate the importance of where the DEA places a drug on the schedule and how the FDA describes the approved drug in terms of importation, research, and ultimately commercial viability of a drug.

Psychedelic research is here to stay. How that research progresses largely depends on whether psychedelic drugs get rescheduled, whether and how patents are issued, and state laws. In the next article, I will further discuss paths to drug development specific to psychedelics and some of the legal issues that will likely arise including whether the drug is novel that would dictate the pathway to approval and ultimately the length of time to potential commercial availability.

See the article here:
The Trials And Tribulations Of Psychedelic Research - Benzinga - Benzinga

Former Trump administration Attorney General Bill Barr is in talks to cooperate with the House select committee investigating the January 6 attack on the U.S. Capitol, according to an individual close to Barr.

Committee chair Rep. Bennie Thompson told "Face the Nation" in January that the select committee "had conversations with the former attorney general already," and an individual close to the Barr confirmed the panel contacted him for what was described as an informal conversation to see whether he had information related to the Capitol attack or the actions of former Justice Department official Jeffrey Clark.

When asked about a draft executive orderobtained by Politicothat was given to former President Donald Trump directing the Defense Department to seize voting machines after he lost the 2020 election, Thompson, a Democrat from Mississippi, said, "we've had conversations with the former attorney general already. We have talked to Department of Defense individuals."

At that time, Barr said he did not have any visibility into the events of January or Clarke's work and did not feel he had much information that could be useful to the select committee. Barr resigned from his post as attorney general in December 2020 and ended his tenure at the department on December 23.

Clark, a key figure in raising doubts about the integrity of the election with Trump, attempted to use Justice Department resources to delay certification of the 2020 election results, according to a report from the Senate Judiciary Committee. Clark was in contact with Mr. Trump in the days leading up to January 6, according to the Senate Judiciary committee's report.

The select committee issued a subpoena for his testimony in October. The committee had moved to hold Clark in contempt late last year when he failed to appear but granted him a reprieve after he indicated he would appear for a deposition and invoke the Fifth Amendment.

While Barr was considered a defender of Trump while he led the Justice Department, their relationship soured in the wake of the 2020 presidential election after Barr told the Associated Press that federal investigators had not found evidence of widespread voter fraud, as Trump claimed.

A source familiar with the situation confirmed to CBS News in October that former acting Attorney General Jeffrey Rosen sat for an interview with the committee. It lasted around 8 hours.

The committee is winding down its investigations ahead of planned public hearings, set to start on June 9. Thompson said earlier this week that he didn't expect the committee would call Trump as a witness.

Thompson said earlier this week the first hearing will "more or less" show what the committee has learned over the past year.

The House select committee was created last year by Speaker Nancy Pelosi to investigate the January 6 attack, when thousands of Trump supporters descended on the Capitol as Congress counted the electoral votes, a largely ceremonial final step affirming Mr. Biden's victory. Lawmakers were sent fleeing amid the riot, which led to the deaths of five people and the arrests of hundreds more. Trump, who encouraged his supporters to "walk down" to the Capitol during the rally at the Ellipse before the electoral vote count, was impeached by the House one week later for inciting the riot but was later acquitted by the Senate.

The committee has issued dozens of subpoenas, including ones to Trump's allies, former White House officials, campaign aides and individuals involved in the planning of the rally outside the White House before the Capitol building came under siege. Two top Trump allies, Steve Bannon and former White House chief of staff Mark Meadows, have been held in contempt of Congress for refusing to comply with subpoenas, and the Justice Department has charged Bannon. Both said they are following instructions from Trump, who has claimed executive privilege.

Rebecca Kaplan, Zak Hudak and Ellis Kim contributed to this report.

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Trump Attorney General Bill Barr in talks to cooperate with January 6 committee, source says - CBS News

As long as the muscle-flexing current Supreme Court majority purports to be bound by the constitutional language adopted in the first years of our Republic, honesty and consistency should compel them actually to look to that text.

Here is the Ninth Amendment (1791) in full: The enumeration in the Constitution of certain rights, shall not be construed to deny or disparage others retained by the people.

The justices may not like the Ninth Amendment, but it directly demonstrates how deeply rooted and explicit was the Framers intention to include rights not specifically mentioned.

Roe v. Wade identified such a right, but that decision hardly stood alone. Justice Samuel Alitos leaked draft is disingenuous at best in its search for a particular word in the Constitution.

In Marbury v. Madison (1803), for instance, Chief Justice John Marshall and a unanimous Court established the Courts power to declare government actions unconstitutional. This judicial review power cannot be found anywhere within the constitutional text. Indeed, the Marbury court also proclaimed again without any textual anchor that William Marbury had a vested individual right to his judicial commission.

Similarly, no constitutional text applies equal protection to the federal government. When the court unanimously held in Brown v. Board of Education (1954) that state public schools segregated by race were unconstitutional, the justices applied that holding to a companion federal case, Bolling v. Sharpe (1954). It was unthinkable, Chief Justice Earl Warrens opinion held that this constitutional right might not apply to the District of Columbia schools. Perhaps Justice Alito would have to concede that the unanimous Bolling decision was not grounded in specific language in the Constitution.

Nor has creative judicial interpolation only been the bailiwick of liberal Justices. For example, the Eleventh Amendments text protected states from lawsuits brought against one of the United States by citizens of another State, or by Citizens or Subjects of any Foreign State. The Court simply ignored this textual limitation when it shielded railroads and the towns that sold bonds to attract them from suits brought by citizens of their home states. Indeed, state governments and state officials continue to enjoy a kind of defensive superpower shield; it is entirely judicial innovation that enables local police officers to defeat federal civil rights claims through the judge-made doctrine of qualified immunity.

In addition, there is growing judicial receptivity to claims by local property owners that state regulations take their property without compensation. Beginning in the 1890s, the court established a purported Fourteenth Amendment basis for such claims by invoking natural equity. This overcame a major textual problem: the early court had held that the Fifth Amendments textual protection applied only to federal takings, and not to those done by states. Nonetheless, after the Civil War, the Fourteenth Amendment omitted the Fifth Amendment takings language entirely as it otherwise directly quoted the rest of the Fifth Amendments due process language. The Court itself later plugged this textual hole through the vagaries of what it termed due protection, and this takings doctrine addition continues to expand.

With luck, Justice Alito may turn out to be writing a concurrence. As a matter of constitutional text and history, his draft surely is unworthy of a majority vote. Recent New York Times columns by Linda Greenhouse and Emily Bazelon underscore how completely Alitos draft ignores the actual impact his decision would have on womens lives. Yet it also bizarrely assumes that, because of progress since 1973, a womans right to choose an abortion somehow is no longer salient.

Unfortunately, Alitos extremely selective brand of textualism makes it now seem realistic to fear that Loving v. Virginia (1967) which struck down state laws against interracial marriage could be on the chopping block; certainly it makes same-sex marriage seem shaky at best. In fact, one vainly searches the Constitution for words such as marriage, and privacy. Missing also are references to contraception or parental authority. Nor is there any mention of campaign funding, for that matter.

The current courts blatant manipulation of its shadow docket indicates no principled limits regarding which precedents will fall away. But the Constitutions structure and the longstanding recognition of implicit constitutional rights should matter much more than any narrow word search seeking a desired result. There is great wisdom in the idea that the past has a vote, but it does not have a veto.

Aviam Soiferserved 17 years as dean of the William S. Richardson School of Law at the University of Hawaii, after five years as dean of the Boston College Law School.He has been teaching and writing about constitutional law and legal history for over 40 years, often focusing on the post-Civil War period.

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The Supreme Courts text mess - The Hill