Results matching “FDA ”

News Scan

Killer Juul: An article by CNBC reports that the Federal Prosecutors in California are issuing a criminal investigation against Juul, a high selling vaping company. Juul is a company that heavily advertises to teenagers and it is now coming into light as the death toll for Juul related illness rises. Statistics in this article indicate that "in 2016, more than 2 million U.S. middle school and high school students used e-cigarettes over a 30 day period", this is incredibly harmful to young children because it may stunt their brain development. This issue requires immediate attention because there is no way of knowing exactly what is in these Juul products that are causing lung illness and resulting in death. In a supporting article by CNBC, Mitch Zeller, director of the FDA center for tobacco products states, "there's no one compound, ingredient, constituent, including vitamin E acetate that is showing up in all of the samples" with this statement it is safe to say that all Juul products should be avoided until further information is released on what these products contain.

Oklahoma Court Upholds Death Sentence:  The Associated Press reports that Oklahoma's highest criminal court upheld the death sentence of Donnie Harris, who murdered his estranged girlfriend in 2012.  The Court's unanimous decision indicated that Harris and 25-year-old Kristi Ferguson had been in a tumultuous relationship when, late on February 18, 2012, the residents of a neighbor's home heard screaming on their front porch.  They found Ferguson nearly naked with severe burns over her body screaming in pain and Harris telling her to shut up.  First responders testified that Harris tried to keep Ferguson from telling them what happened, but she managed to say, "He did this to me. ... He threw kerosene on me and set me on fire."  Ferguson died 19 days later from second and third degree burns over 50% of her body.  Doctors testified that the pain associated with Ferguson's injuries would have been unimaginable.  Overwhelming evidence convinced the jury to find Harris guilty of pouring gasoline over the girl's body and setting her on fire, and unanimously recommend a death sentence.  Harris argued that he had not received a fair trial.   

Be Careful What You Ask For

In 2011, a group of death row inmates sued the FDA to block the importation of sodium thiopental, a barbiturate that is highly effective in ensuring that lethal injection executions are nearly painless. Among the plaintiffs was Stephen Michael West.

As reported by The Tennessean:

West was sentenced to death for the 1986 stabbing deaths of Wanda Romines, 51, and her 15-year-old daughter, Sheila Romines, in their East Tennessee home. He also was convicted of raping Sheila.

Investigators say the women had been tortured in front of one another before they died.

Price Executed, Finally

Alabama yesterday finally achieved justice for the murder of Bill Lynn. Previously, the Supreme Court had effectively given murderer Christopher Price a stay by waiting too long to vacate the stays erroneously granted by lower federal courts. See prior posts here and here.

Justice Breyer wrote a dissent more notable for what it does not say than what it says.

News Scan

Justice: FDA Cannot Screen Execution Drugs:  In a legal opinion announced earlier this month, the Justice Department's Office of Legal Counsel announced that despite a 2012 Federal Court injunction, the FDA does not have the authority to regulate drugs used for lethal injection.  Laurie McGinley and Mark Berman of the Washington Post report that the former head of the FDA wanted to maintain control over state access to execution drugs, but the story misses the fact that in Cook v. FDA, the agency opposed a federal district judge's 2012 injunction requiring that it perform that task.  The DOJ opinion provides support for a 2017 lawsuit by the state of Texas claiming that the FDA is preventing the state from enforcing the law.  If the injunction is lifted states would be able to import the most effective lethal injection drugs without having to win approval from the FDA.  

Faux Pas Act Up for Senate Vote

The bill titled the First Step Act is coming up for a vote in the Senate as early as the end of this week, Natalie Andrews reports for the WSJ. As I explained in this post in August, the version that passed the House would more appropriately have been called the Faux Pas Act. The Senate version is no better.

As explained in more detail in my July letter to Senator Cotton, the claim that this bill requires participation in "evidence-based" rehabilitation activities to earn credits is a shameless fraud. The definition of "evidence based" is so loose as to be wide open to junk science, and then on top of that the bill allows credits for "productive activities" in the alternative, which can be practically anything the Bureau of Prisons says.

The Senate version also includes some cutting back on mandatory sentencing provisions. I will leave commentary on that to others.

Paul Mirengoff has this post at PowerLine. See also Daniel Horowitz at Conservative Review.

From the WSJ story:
In an impromptu statement October 27 on the Pittsburgh synagogue shootings, President Trump said:
I think one thing we should is we should do is stiffen up our laws in terms of the death penalty. When people do this, they should get the death penalty, and they shouldn't have to wait years and years. Now, the lawyers will get involved, and everybody is going to get involved, and we'll be 10 years down the line. And I think they should stiffen up laws, and I think they should very much bring the death penalty into vogue. Anybody that does a thing like this to innocent people that are in temple or in church -- we had so many incidents with churches -- they should be -- they should really suffer the ultimate price. They should pay the ultimate price. I've felt that way for a long time. Some people disagree with me. I can't imagine why. But this has to stop.

I've felt that way for a long time, too, Mr. President. Now what are you going to do about it? It's been almost two years since your election, and you haven't done anything at all yet, as far as I can tell.

Peter Loftus reports for the WSJ:

An advisory panel to the Food and Drug Administration recommended the agency approve what could become the first prescription drug in the U.S. derived from the marijuana plant, as a treatment for people with rare forms of epilepsy.
*      *      *
The FDA is expected to decide by the end of June whether to approve the drug for sale. The agency isn't required to follow the advice of its advisory committees but usually does. GW Pharmaceuticals proposes to call the drug by the brand name Epidiolex.
Is removal of marijuana from Schedule I likely to happen this year?
Joe Palazzolo reports for the WSJ (emphasis added):

A Johnson & Johnson company opposes plans by Florida authorities to use one of its drugs in an upcoming execution, marking the first time the world's largest pharmaceutical manufacturer has waded into the death penalty debate.

Earlier this year, Florida amended its lethal injection protocol to include etomidate, an anesthetic agent that has never been used in executions, after exhausting its supply of the sedative midazolam.

Florida authorities are slated to use the updated protocol for the first time on Thursday in the execution of Mark Asay, who was sentenced to death for the 1987 killings of Robert Lee Booker and Robert McDowell in Jacksonville, Fla.

Scientists at Johnson & Johnson's Janssen Pharmaceuticals NV created etomidate in the 1960s. The company no longer distributes the drug, which is still used in hospitals.
Excuse me, J&J, but if you no longer make or distribute this drug, and if the patent expired long ago, how exactly is this any of your damn business?

News Scan

New Hampshire Decriminalizes Pot:  New Hampshire Governor Chris Sununu signed a bill into law which reduces the penalty for possession of 3/4 oz. or less of marijuana or 5 grams of hash and converts it to a civil offense.  The Associated Press reports that a person caught with these amounts of pot or hash would face a fine of up to $100.  New Hampshire joins 20 other states which have decriminalized possession of marijuana.   

More Arrests in NY Gang Killings:  Suffolk County, NY, police officials announced Wednesday that at least four additional MS-13 members had been arrested for the April murders of four young men at a Long Island park.  Liz Robbins of the NY Times reports that with the recent arrests, 15 members of the gang will be facing charges in the quadruple homicide, while a total of 17 members face federal murder charges for at least 12 murders and other crimes.  The crackdown began in March when MS-13 members were arrested for the brutal April 2016 machete/baseball bat murders of two teen-aged girls in Brentwood.  After the bodies of the four Long Island victims were discovered, Attorney General Jeff Sessions said in a statement to MS-13 members, "We are targeting you, we are coming after you."   
Attorney General Jeff Sessions just held a news conference at which he confirmed that his answers about Russia contacts during his confirmation hearings were true answers to the questions as he understood them -- about contacts concerning the campaign or as a spokesman for the campaign and not unrelated contacts in his capacity as Senator.  However, he will recuse himself from any matters involving the Trump campaign.

Now the Senate Judiciary Committee and the full Senate need to get moving on the Deputy Attorney General nomination.  We have already seen what can happen when important decisions are made by Obama holdovers.

The WSJ has a stub of a story here, which says it will be updated as the story develops.

News Scan

Georgia DA Seeks Death for Alleged Cop Killer: In Byron county GA, the district attorney intends to seek the death penalty for the suspected murderer of two Georgia police officers. Fox News reports that District Attorney David Cooke announced Thursday that his office will seek the death penalty against 57-year-old Ralph Stanley Elrod Jr. A grand jury indicted Elrod this week on the charges of aggravated assault and murder of Deputy Daryl Smallwood,39, and Sgt. Patrick Sondron, 41. The officers were reportedly responding to a call about the suspect making threats with a rifle when the officers were shot.

Indiana Murderer May Have Forfeited Review:  The Indiana Supreme Court is set to consider if a murderer's refusal to sign court documents for post-conviction relief will end further review of his case. Dan Carden at the NWI Times reports that Kevin Isom, 51, was convicted of the 2007 murders of his wife and two stepchildren and was given the death penalty for the crimes. After the state Supreme Court upheld his conviction and sentence on direct review, Isom refused to sign the required documents for post conviction (habeas corpus) review until he was given an attorney he likes.  The Superior Court ruled that if Isom would not sign, his right to further review was forfeited.  Isom's attorneys, apparently without his permission, have appealed that holding. The state's brief in the case is here

Parolee Charged With Murder After an Car Accident:  A parolee in Indio, CA. has being charged with murder for gunning down a man who ran into his SUV.  As reported by CBS news James "Chip" Milton Nathaniel, 30, in addition to being charged with murder, he also faces charges of being a felon in possession of a firearm.  Nathaniel was released from prison on parole 2014 for shooting a man in 2005.  Nathaniel is now facing trial for murder for reportedly firing multiple rounds into the 35-year-old victim following a collision between the vehicles of the two men in 2015. 

News Scan

OH Plans January Execution Using 3-Drug Combo:  Representatives for Ohio announced Monday of the state's plans to resume executions in January with a new three-drug combination, following a three-year moratorium brought on by drug shortages and legal challenges.  Andrew Welsh-Huggins of the AP reports that the drugs intended for use by the state are midazolam, which renders sleep, recuronium bromide, which causes paralysis, and potassium chloride, which stops the heart.  The drugs have been approved by the FDA and are not compounded, says Thomas Madden of the Ohio attorney general's office.  The last time Ohio carried out a death sentence was January 2014, when Dennis McGuire was put to death in a procedure that took 26 minutes using a two-drug combo that had never been tried.  It was McGuire's execution which led to several complicating legal problems and changes to the state's death penalty system.  There are over two dozen inmates on Ohio's death row with firm execution dates, some of which are scheduled as far out as October 2019.  The next inmate in line to be executed is Ronald Phillips, who raped and murdered his girlfriend's three-year-old daughter in 1993. 

Video Shows Mob Attacking CHP Patrol Car with Officer Inside:  A newly released video taken on Sept. 25 in Fresno, Calif., shows a police officer who responded to several calls about illegal street racing and reckless driving become surrounded by a mob of people yelling at him and kicking his vehicle while he sat inside.  Kristine Guerra of the WaPo reports that the crowd of 30 to 40 people shouted, "F the police, we run the streets," as they violently kicked the sides of the officer's SUV and recorded the incident on their phones.  The officer, whose name has not been released, drove away unharmed, while his patrol car sustained $12,000 worth of damage.  Police have arrested three men in connection with the incident, two of whom are members of the Bulldog gang, and more suspects are being sought.  Fresno Police Chief Jerry Dyer said during a Friday news conference that he believes this incident is a symptom of the current environment of riots and targeted attacks on police officers across the nation.

NY Community Reeling from Violent Impact of Immigration Policies: 
A violence-plagued Long Island, N.Y., community is pointing a critical finger at federal and local immigration policies that have allowed illegal immigrants to flood Suffolk County and gangs to thrive.  Joseph J. Kolb of Fox News reports that over the past four years, 225,725 unaccompanied Central American children entered the U.S., 3,500 of them placed in Suffolk County between October 2013 and July 2016.  A federal policy allowing Central American children apprehended at the border to be placed with illegal immigrant sponsors has enticed thousands of unaccompanied minors to journey to the U.S., where they are often placed in homes with little supervision and government monitoring.  The HHS website indicates that in FY 2015, only 1,895 home visits were conducted out of 33,726 referrals made by DHS.  This means that young migrants are even easier to target for gang recruitment by the MS-13, a notorious El Salvadorian gang that is thriving under Suffolk County's sanctuary city policies.  Last month, two 15-year-old girls were brutally murdered and the skeletal remains of two teenage boys were discovered, all allegedly connected to MS-13. 
One of the ploys that opponents of the death penalty use to try to block it -- given that the American people are solidly against their real position -- is to drag out the appeals process for decades and then claim that it is cruel to keep people on death row for decades.

This is called the Lackey claim for Justice Stevens's solo opinion in Lackey v. Texas, 514 U.S. 1045 (1995).  After Justice Stevens retired, Justice Breyer took up the cause.  He reiterated his position last night in the last minute appeal of Georgia murderer John Wayne Conner.  But he is still alone.  No other justice joined his dissent.

Conner was executed at 12:29 a.m. Friday with the single-drug method using pentobarbital, Rhonda Cook reports for the Atlanta Journal-Constitution.  Georgia can apparently still get pentobarbital, the preferred drug for this purpose, though most states cannot.

The lethal injection drug shortage is entirely artificial and due in large part to the misinterpretation of the Food, Drug, and Cosmetic Act by the D.C. Circuit in Cook v. FDA, 733 F.3d 1 (2013).  Congress can and should correct that misinterpretation with a simple fix.

5 Reasons Marijuana Is Not Medicine

Bertha Madras, professor of psychobiology at McLean Hospital and Harvard Medical School, has this article in the WaPo with the above title.

Data from 2015 indicate that 30 percent of current cannabis users harbor a use disorder -- more Americans are dependent on cannabis than on any other illicit drug. Yet marijuana advocates have relentlessly pressured the federal government to shift marijuana from Schedule I -- the most restrictive category of drug -- to another schedule or to de-schedule it completely. Their rationale? "States have already approved medical marijuana"; "rescheduling will open the floodgates for research"; and "many people claim that marijuana alone alleviates their symptoms."

Yet unlike drugs approved by the Food and Drug Administration, "dispensary marijuana" has no quality control, no standardized composition or dosage for specific medical conditions. It has no prescribing information or no high-quality studies of effectiveness or long-term safety. While the FDA is not averse to approving cannabinoids as medicines and has approved two cannabinoid medications, the decision to keep marijuana in Schedule I was reaffirmed in a 2015 federal court ruling. That ruling was correct.
The President, the Attorney General, and a great deal of the political establishment in Washington vocally back legislation to provide mass, and retroactive, sentencing reduction for federal felons.  Drug traffickers lead the list of intended beneficiaries. The establishment politicians call their proposed reductions sentencing "reform," in a somewhat half-hearted attempt to disguise what they're actually up to.  

It's simply beyond sensible argument that such "reform" would mean more crime faster, the federal recidivism rate being at about 50%.  "Reformers" like to fuzz over this fact, but the numbers don't lie.  "Reformers" think that paying the price in increased crime (which they either deny, minimize or garble) is worth it because America has just gone overboard with incarceration, or should adopt a medical model of crime, or is a racist pigsty, or some mix of the three.  Some also believe, or say they believe, that prison costs too much, although none has yet taken my bet the the DOJ budget will increase whether this legislation passes or not.  At some level, they know that "reform" will not save the taxpayers a single dime; the money will just get spent on different DOJ projects.

Career Assistant US Attorneys  --  the non-political, line prosecutors who have to deal with reality rather than indulge Al Sharpton's ideological fantasies  --  are sounding the alarm.  It take guts to do so.  No one wants to be on the outs with the boss, particularly when the boss is the Attorney General.

No AUSA has been more outspoken, or more courageous, than the head of the National Association of Assistant US Attorneys, Steve Cook.  Although I have never met Steve, I am proud to have corresponded with him and to have benefited often from his knowledge.

Congressional Quarterly (link regrettably unavailable) has taken grudging note of Steve's courage and impact.  I reproduce its April 4 article about him after the break.
Astrid Galvan and Justin Pitchard report for Association Press:

Compounding the nation's severe shortage of execution drugs, federal authorities have confiscated shipments of a lethal-injection chemical that Arizona and Texas tried to bring in from abroad, saying such imports are illegal.

The Food and Drug Administration said Friday that it impounded orders of sodium thiopental, an anesthetic that has been used in past executions in combination with drugs that paralyze the muscles and stop the heart. It currently has no legal uses in the U.S.
Multiple errors in the story here. Thiopental has also been used alone.  When Ohio pioneered the single-drug method, it used thiopental.  The drug was used in medical treatment for decades, and there is no prohibition against using it.  No company ever went through the FDA approval process for it, probably because it has been around since before such approvals were required. 

"Courts have concluded that sodium thiopental for the injection in humans is an unapproved drug and may not be imported into the country," FDA spokesman Jeff Ventura said in a statement.
Actually there is only one case.  The "courts," plural, are the District Court and Court of Appeals in that one case, Cook v. FDA

That case was wrongly decided, in my opinion.  The Supreme Court 30 years ago decided in Heckler v. Chaney that the FDA has discretion to not enforce the restrictions of the Food, Drug, and Cosmetic Act in a context where it was never meant to apply and where its requirements make no sense.  What is "safe and effective" for an execution drug?  Effective for this purpose is necessarily the ultimate unsafe.  However, the Cook court (the same court the Supreme Court reversed in Heckler) thought the importation law was distinguishable from the domestic use law at issue in Heckler.

The state have partly themselves to blame for not fighting that decision.  Now they need to vigorously take this up to the Supreme Court to have Cook overruled or get Congress to abrogate it by statute.  Prohibiting the importation of the drug that is clearly superior to the midazolam approved in Glossip is just crazy.

For the full background and a legislative proposal, see this paper.

California's New Death Row -- Virginia

The title of this post is taken from Debra Saunders' spot-on and mind-bendingly ironic column in today's SF Gate. As Ms. Saunders notes:

California has a new Death Row -- it's called Virginia. Death penalty opponents, federal judges and defense attorneys have been so successful at blocking capital punishment in California that a San Quentin Death Row inmate has more to fear from being extradited for a capital murder to another state than seeing his sentence carried out here. There has been no execution in California since a federal judge effectively halted the practice in 2006.

There is undoubtedly someone more deserving of execution than the killer facing his imminent punishment in Virginia, but it's hard to think of one off-hand:

Take serial killer Alfredo Prieto. In 2005, Prieto was on San Quentin's Death Row for the 1990 rape and murder of 15-year-old Yvette Woodruff in Riverside County, when DNA evidence linked him to three 1988 murders in Virginia. Under Gov. Arnold Schwarzenegger, California sent Prieto to Virginia, where killers sentenced to death actually face the likelihood of execution. (Authorities say evidence links Prieto to nine murders.) In 2010, a Virginia jury sentenced Prieto to death for the murder of Rachel Raver and Warren Fulton, both 22. Prieto is scheduled for lethal injection at the Greensville Correctional Center in Virginia Thursday night. Just 13 inmates have been executed in California since the death penalty resumed in 1978. Prieto will become the second√ California Death Row prisoner to be executed in another state.

We will probably never know how many innocent people are dead because Prieto wasn't executed before now.

Euthanasia in Europe

Charles Lane has this opinion article in the WaPo, headlined, "Europe's sinister expansion of euthanasia."  CJLF takes no position on the issue, and I won't volunteer my personal opinion, at least not today, but I thought I would note this paragraph:

Frank van den Bleeken, imprisoned for 30 years for rape and murder, sought euthanasia from Distelmans, citing his incurable violent impulses and the misery of life behind bars. Belgian officials and Distelmans initially agreed; a lethal injection the murderer might have gotten as punishment in the United States would be supplied as therapy in anti-death penalty Europe.
And what do Belgian doctors prescribe for a painless death?  Sodium thiopental, the drug we are blocked from importing by the D.C. Circuit's dubious decision in Cook v. FDA.

How Dylann Roof Got the Murder Weapon

Scott Johnson reports:

After Dylann Roof murdered nine pastors and churchgoers in the course of Bible study in Charleston, President Obama couldn't wait to use the occasion for his narrow political purposes. "Let's be clear," he said with urgency in his voice. "At some point we as a country will have to reckon with the fact that this type of mass violence ... doesn't happen in other places with this kind of frequency. And it is in our power to do something about it." The implication, of course, was that additional gun control legislation was required but that his political opponents refused to see the light.

Now we learn in whose power it was to do something about it, and it wasn't anyone Obama was talking about. The Washington Post reports: "Dylann Roof, who is accused of killing nine people at a church in South Carolina three weeks ago, was only able to purchase the gun used in the attack because of breakdowns in the FBI's background-check system, FBI Director James B. Comey said Friday." The White House, of course, declines to comment.

I said at the time of his nomination that Jim Comey was a man of integrity.  I feel vindicated today.  As to his boss, I have as much comment as the White House.

Sanctuary Cities and Blood

Miriam Jordan and Zusha Elinson report for the WSJ:

The fatal shooting of a woman in San Francisco last week, allegedly by an illegal immigrant man convicted of seven felonies and previously deported to Mexico, has sparked a debate about the extent to which local law enforcement and federal immigration authorities should cooperate.

At issue is the Department of Homeland Security's practice of seeking to identify potentially deportable individuals in jails or prisons nationwide by issuing a "detainer," a request rather than an order to extend the individual's detention.

Kathryn Steinle, 32 years old, was walking with her father along Pier 14 on the evening of July 1 when she was shot in her upper torso, police said. She later died at a hospital.

*                               *                             *

On March 26, [the suspect, Francisco] Sanchez was booked into the San Francisco County Jail on a local drug-related warrant after serving a federal prison term, the city's sheriff's office said. The next day, Mr. Sanchez appeared in San Francisco Superior Court and the drug charges were dismissed.

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