Daily Archives: May 21, 2022

In the Dred Scott decision, Roger B. Taney, led the court in ruling that Black people could never be citizens of the United States and that slavery could not be banned in any state. The Supreme Court in the case of Dobbs, which will overturn Roe v Wade will have the same result.

Red states like Missouri already have plans that other red states will follow to sue doctors in other states that perform abortions on Missouri women. There is talk of charging women who go to another state for an abortion to face criminal charges when she returns to her home state. Such laws will in effect nationalize the ban on abortion, thus enslaving womens bodies throughout America.

Women should not count on a gang of religious zealots on the Supreme Court groomed by the Federalist Society to protect her rights under the privileges and immunities clause of the Constitution or under the Fifth Amendment when she goes to another state.

History rhymes in that black citizens, who sought such protections when traveling from state to state were denied them in the 19th Century. Current red state efforts will become Americas new de facto fugitive slave act, because red states will reach across borders to interfere with women getting an abortion.

Women activists are preparing for the end of Roe v Wade, and efforts are underway to create a new underground railroad that will help women get access to abortion where it is legal, and also to enable women to get necessary contraception and abortion pills as well. But these women will face the same risks of breaking the law that earlier railroaders faced.

The conservative war on women on will continue to not only deny pregnant women abortions, but to ban contraception as well. Women will become secondary citizens in America under patriarchal rule.

George Magakis, Jr., Norristown, Pa.

Continue reading here:
There will be a new version of the Underground Railroad to help women seeking abortions | PennLive letters - PennLive

Now that rent control has made it onto the ballot, I have a couple questions? Why arent gas stations being forced to lower prices? Gas is crazy high. Why arent grocery stores having to keep costs in check? Those prices are skyrocketing. I could go on, but you get the point.

Placing the burden of lowering rents on the shoulders of mom and pop landlords who are having just as difficult a time with inflation as anyone is a veiled taking of private property rights and a violation of the fifth amendment of the US Constitution. Oh, wait, violatingrights seems to be okay these days.

Ive lived in Pasadena for more than 50 years. During that time, I was both a renter and a landlord. Toward the end of my dads life, I was able to move him into a duplex I owned so I could better care for him. If this ordinance had been in place, that might not have been possible. Sorry mom and dad, youre on your own.

I understand renters are angry and hurting. But, blaming and burdening our struggling mom and pop landlords is not the solution.

Pasadena is not doing enough to create much needed affordable housing, but that is no reason to take rights away from individuals who have worked hard to achieve what the City cannot. There are approximately 3,000 mom and pop landlords in the City of Pasadena that are struggling with a worsening economy just like everyone else these individuals did not sign up to do the job that our elected officials willingly agreed to do, yet sadly, are not.

When money is taken from mom and pop landlords, they have less money to make needed repairs and the quality of rental properties goes down.

Thats a fact. But wait, according to the proposed rental ordinance, mom and pop landlords also get penalized for not making the repairs they can no longer afford to make. Hows that going to work out?

Pasadena currently has the high number of rental properties it does because it abides by reasonable State rental laws. Make the rules unreasonable, and people will stop building rental units in Pasadena. How are fewer rental units in Pasadena going to make prices go down?

It isnt.

Simple economics says the answer is to build more affordable units. To disincentivize future rental units will stop new construction. Thats what rent control does. What may help in the present will definitely hurt down the road. It will take a bad situation and make it worse.

Just like we cannot force gas stations to subsidize high gas prices, nor ask grocery stores to artificially keep prices low, we should not force mom and pop landlords to provide subsidized housing. Its not fair, and it is not the answer. We live in a country that does nottake from private individuals without just cause theres that 5th Amendment again. But this ordinance does just that.

If we want a more affordable city, the City needs to require more affordable units in all new construction it also needs to fast-track the building of affordable units on church property, explore creative reuse of existing buildings, make it easier to build affordable units in the City, and any number of things its not doing enough of right now.

Kicking the can down the road by kicking mom and pop landlords and their families is a lose-lose solution. In the long run, it will degrade our precious existing housing stock and hinder the building of new units.

Todd HayesPasadena resident and Realtor

Get all the latest Pasadena news, more than 10 fresh stories daily, 7 days a week at 7 a.m.

Read more here:
Guest Opinion | Todd Hayes: Landlords Have Rights Too. Where Does the Taking of Rights Stop? Pasadena Now - Pasadena Now

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.

See the article here:
The Supreme Courts text mess - The Hill

So I have about 100,000 things I should be doing right now but my little wheels are turning and I figured Id share these thoughtshalf-baked though they arewith TCPAWorld before I forget.

The FTC just issued anNPRM requiring marketers to hold on to recordstons of records. All of the outbound calls theyve made. Copies of consent records (or the lack thereof). Basically anything a PROSECUTOR could ever want to use against a caller in a criminal case.

How is that supposed to make lawful marketers feel? Theyre basically being told to hold onto every record of their activities in case the government wants to come snooping into it one day.

I have to say I view this as a government agency basically just picking on a group of Americans who are politically unpopular right now just because it can. Just because a company engages in direct-to-consumer marketing doesnt mean theyre a criminal enterprise. And Im not sure they should be presumptively treated as one. Especially since I know a lot of these good folks who try their level best to comply with the law while also trying to make a living.

I dont like how this NPRM treats these good folks.I dont like it at all.

And I get it, wrongdoers should be prosecuted. Except that we all have the right to be secure in our possessions against unwarranted searches and seizures. And we have the right to not testify against ourselves. Andmost importantlywe have the rightnot to be treated as wrongdoers until we actually do something wrong.

If the government has probable cause to seize my records because I have committed a crime (or there is probable cause to believe that I have) well, my records are going to get seized. But it cant seize my recordsor, in my viewrequire me to seize my own records for their convenient production on a later datesimply because it thinks I might do something wrong in the future. Or simply because Im engaged in a profession thatotherpeople misuse.

Breaking this down a bit more, the case law is pretty clear that being compelled to produce business records that werevoluntarilycreated is not a fifth amendment issue. A business has no fifth amendment rights (for some reason) and a person cannot (again, for some reason) assert a privilege against business records even where they are in their possession. (Unless the act of production is, itself, testimonialwhich it sometimes can be.)

The limits on the protection against unwarranted searches and seizures are a bit less clear in this context, though. For instance, the warrantless obtaining of cell phone location data was too much for the Supreme Court tohandle back in the oldCarpentercase.The rationale was that if cell phone location data were wide open to government use the government would essentially have a 4 year look back on the whereabouts of every American. It could then pick and choose who to observe, whenever it saw fit to do so.

When I reflect on the FTCs new document retention protocol, this feels a lot likeCarpenterto me. You have the government essentially mandating a hold on every record of outbound callingcompletely lawful conduct, btw. That is unquestionable a form of seizure. The documents must be housed in ready condition for the government to come pick them up on demand. Presumably, the retrieval will require a warrantthat part isnt clear to me yetbut isnt thewarrantlessrequirement that documents remain seized (albeit in someone elses possession)itselfa violation of the fourth amendment?

And when you combine these concerns with the Fifth Amendment protections against self incriminationthat, again, barely exist in this contextit almost feels like the government is intentionally setting up a trap here. Likeeveryonewho engages in telemarketing (including lawful telemarketing) is now going to be subject to intensive/complete government review at any given moment. They areforcedto maintain records, only to beforcedto produce those records at the whim of a government official one day.

Now Im not saying the bad guys should get away. But usually, prosecutors should have to prove their casewithoutrequiring criminals to testify against themselves (including by forcing them to hold on to all of the evidence of their activities over a multi-year period of time so that they can hand it over one day.)

And the thing thatreallybothers me is how direct the FTC is in its approach here. It literally argues that the record retention rules are necessary to assist law enforcement efforts. Theres so subtlety. Its not like theres an argument that theres some other reason that the records should be maintained other than those that might trample constitutional rights. The FTC is literally directing marketers to hold onto their records for theexpress purposeof potentially having to testify against themselves (in the actual non-legal sense of those words) by producing the records to law enforcement down the line.

Essentially its just going to treat all marketers like criminals. And hey, if youre not doing anything wrong youve got nothing to worry about right?

The cry of an authoritarian regime.

I grant you I amonlya nationally-recognized scholar on theFirstAmendment, and not the Fourth or Fifth. So theres probably a bunch of subtlety here Im missing (or perhaps, ignoring because I dont like it.) But theres something to this argument.

Intuitively, the government cant force you to keep all records of your (lawful) conduct and then demand its production later on the off chance you did something wrong. Thats not a free society. Not even close.

At a minimum, the ruling should specify that government officials cannot take possession of records seized.. er, retained by businesses under the rules without a warrant.That has to be in there. It just has to be.

Anyway, I leave this to you TCPAWorld to run with. I cant take the lead on this one. Have too many other projects right now. Go fight the good fight. Thanks.

Excerpt from:
FTC Proposed Rule Could Require Telemarketer to Keep Records of Every Call - The National Law Review

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.

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

Several polls indicate that housing affordability continues to be a major issue across the nation.

As discussed in past blog posts, the Federal and state and local governments continue pushing for changes in zoning regulations to ensure that more housing units are affordable to more people in more areas.

In support of that goal, several communities, including Pittsburgh, are pursuing an approach called inclusionary zoning to ensure that residential developments include a minimum amount of housing units that are affordable to low- or moderate-income residents. The idea behind inclusionary zoning is to create mixed-income developments and neighborhoods. Municipalities are seeking to achieve inclusionary zoning by implementing either voluntary or mandatory zoning regulations.

The voluntary approach typically includes offering a developer one or more carrots (i.e., incentives). For example, in exchange for including a certain amount of affordable housing units in a development, a developer may be permitted the right to increase the developments density, height or coverage, or reduce required parking or setbacks. Other voluntary incentives include expedited approval processes or waiving/reducing fees to reduce time and costs.

While the carrot approach is preferable and usually more accepted, some communities, like Pittsburgh, choose to use the stick (i.e., mandatory) approach. Recently, Pittsburgh City Council voted to expand its mandatory Inclusionary Housing Overlay District (I-ZO) to certain other neighborhoods. The I-ZO requires that for residential developments of 20 or more housing units, at least 10% of the units must be designated as inclusionary units for rent or ownership by eligible households.

For rental inclusionary units, eligible households are those households earning no more than 50% of the areas median income. For owner-occupied inclusionary units, eligible households are those households earning no more than 80% of the areas median income. Inclusionary units must remain affordable for eligible households for an initial term of 35 years. In instances where inclusionary units or the subject property are sold during the initial 35-year term, the term automatically renews for another 35 years.

Other standards for inclusionary units in Pittsburghs I-ZO include providing that such units are: (i) distributed within and throughout the building or development; and (ii) equivalent to market-rate units within the building in all ways, including appliances, finishes and size.

To ensure inclusionary units remain affordable in accordance with these standards, a developer must not only record a deed restriction, but it also must enter into a master lease. Further, where it is not feasible for a developer to provide all of the required inclusionary units on the property, the developer can apply for special exception approval to construct the units at an alternative site. The alternative site must be owned or controlled by the developer and within of a mile of the property. Further, in contrast to the minimum 10% of the units that are required to be inclusionary when located on-site, at least 12% of the units must be designated as inclusionary to construct inclusionary units at an alternative site.

While the intended goal of Pittsburghs I-ZO may be noble, its stick approach has drawn the ire of the Builders Association of Metropolitan Pittsburgh (BAMP). Not surprisingly, BAMP has filed a federal lawsuit challenging Pittsburghs mandatory inclusionary zoning approach on the grounds that it violates the State and Federal constitutions. BAMPs complaint states, in part, as follows:

By way of the Ordinance, the City improperly seeks to shift the burden to fund low- and moderate-income housing from the general public to a select population, namely residential real estate developers. The imposition of this burden on BAMP members constitutes an improper taking of private property without just compensation, in violation of the Takings Clause of the Fifth Amendment, made applicable here by the Fourteenth Amendment, and in violation of the Due Process Clause of the Fourteenth Amendment. As such, the ordinance cannot be permitted to stand.

As more communities look to use zoning to provide for affordable housing, it is expected that there will be an increase in the number of lawsuits, especially in those communities instituting mandatory inclusionary zoning without incentives.

Remember, it is said the way to ones heart is through their stomach. In instances of zoning, carrots certainly taste better and arent as painful as sticks.

See original here:
Inclusionary Zoning: Carrots Taste Better and Arent as Painful as Sticks - JD Supra

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.

Read the original post:
The Trials And Tribulations Of Psychedelic Research - Benzinga - Benzinga