Stay of Execution of Smulls Vacated; Compounding Problem Remains

 

 

Last night, shortly after the State of the Union address, Justice Samuel Alito spared Herbert Smulls' life. Unfortunately, the mercy was short-lived, and he will be executed, likely some time before midnight tonight.
Why was the stay granted initially, and what is so troubling about his execution? The issues are not novel: an all-white jury, plus execution drugs made in secret by a compounding pharmacy. The latter issue, though not dealt with today, is repeating itself across the country and raises important issues of cruel and unusual punishment.

Stay Granted
Smulls' counsel, Cheryl Pilate, filed two last-minute challenges to his execution, after the U.S. District Court in Kansas City and the 8th Circuit Court of Appeals both denied relief. According to the Associated Press, Gov. Jay Nixon denied clemency on Tuesday evening as well.
That left the conservative Justice Samuel Alito as his last hope. A stay was issued last night, about two hours before his scheduled execution at 12:01 a.m., though the stay did not specify the grounds for the temporary relief. The Court's website notes that both challenges were linked on the docket.
Compounded Drugs
As we saw with Warren Lee Hill, thanks to manufacturers' refusals to supply drugs for executions, states are increasingly and controversially turning to compounding pharmacies for execution drugs. And much like Georgia, Missouri refuses to disclose the name of the compounding pharmacy, arguing that the pharmacist is part of the execution team, and its name cannot be released to the public.
The issues with compounding pharmacies are numerous. For one, a mistake in manufacturing can mean a torturous end, and cruel and unusual punishment for a prisoner. These pharmacies produce custom orders of drugs and are not overseen by the Food and Drug Administration. Plus, according to The Associated Press, the state stores the drug at room temperatures, which can reduce the drug's potency.
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FDA Law Blog Industry Challenges Hydrocodone Combination Reclassification in Citizen Petition January 29, 2014

By Delia A. Deschaine –

 

Various members of industry recently joined together in filing a citizen petition with FDA.  Citizen Petition, Docket No. FDA-2013-P-1711 (hereinafter “Citizen Petition”). The Citizen Petition responds to a statement made by CDER Director, Janet Woodcock, M.D. in October 2013 that FDA intends to issue a scientific and medical evaluation and recommendation that DEA reschedule all hydrocodone combination products from their current placement in Schedule III to Schedule II.  The petitioners argue that reclassifying all combination hydrocodone products is inappropriate for myriad of public policy reasons.  Thus they request that FDA instead recommend DEA reclassify only hydrocodone combination products that contain hydrocodone bitartrate in a strength of 5 mg or higher.  Citizen Petition at 2.  While the petition is brief, it touches on several critical points that FDA and DEA will likely consider in determining whether to move forward with the rescheduling.

FDA List of Registered Outsourcing Facilities under 503B is Growing--There are now 23 Compounding Pharmacies on the List

Registered Outsourcing Facilities

Firms Registered As Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Updated as of 1/24/14

 

Information Concerning Outsourcing Facility Registration

 

 

Firm Name	Date of Registration as an Outsourcing Facility1	End Date of Last FDA Inspection Related to Compounding2	Was a Form FDA-483 issued?3	Other FDA Action, if Any, Based on Last Inspection4,5	Compounds Sterile Drugs From Bulk Drug Substances6
Allergy Laboratories, Inc., Oklahoma City, OK	12/30/2013	4/26/2013	Yes1	Warning Letter - 9/4/20132	Yes
Banner Health, Chandler, AZ	12/26/2013	Not yet inspected	N/A	N/A	No
Cantrell Drug Company, Litte Rock, AR	12/16/2013	11/4/2013	Yes3	Open	Yes
Kings Park Slope, Inc., Brooklyn, NY	12/23/2013	Not yet inspected	N/A	N/A	Yes
KRS Global Biotechnology, Inc., Boca Raton, FL	12/15/2013	Not yet inspected	N/A	N/A	Yes
Marlborough Hospital, Marlborough, MA	12/26/2013	Not yet inspected	N/A	N/A	Yes
Medi-Fare Drug & Home Health Center, Inc., Blacksburg SC	12/17/2013	1/18/2013	Yes4	Warning Letter – 3/7/20135	Yes
PharMedium Services, LLC, Memphis, TN	12/11/2013	3/22/2013	Yes6	Open	No
PharMedium Services, LLC, Edison, NJ	12/11/2013	2/28/2013	Yes7	Open	No
PharMedium Services, LLC, Cleveland, MS	12/11/2013	2/22/2013	Yes8	Open	No
PharMedium Services, LLC, Sugarland, TX	12/11/2013	2/27/2013	Yes9	Open	No
Region Care, Inc., Great Neck, NY	12/24/2013	Not yet inspected	N/A	N/A	Yes
SCA Pharmaceuticals, Little Rock, AR	12/13/2013	Not yet inspected	N/A	N/A	Yes
US Compounding, Inc., Conway, AR	12/20/2013	Not yet inspected	N/A	N/A	Yes
Pharmagen Laboratories Inc., Stamford, CT	1/21/2014	8/23/2013	Yes10	Open	Yes
JCB Laboratories, North Wichita, KS	1/21/2014	2/27/2013	Yes11	Open	Yes
Pharmakon Pharmaceuticals, Inc., Carmel, IN	1/23/2014	Not Yet Inspected	N/A	N/A	No
Edge Pharmacy Services LLC, Colchester, VT	1/21/2014	Not Yet Inspected	N/A	N/A	Yes
Triangle Compounding Pharmacy Inc., Cary, NC	1/24/2014	3/1/2013	Yes12	Warning Letter - 1/14/201413	Yes
Infusion Options, Brooklyn, NY	1/24/2014	Not Yet Inspected	N/A	N/A	No
Advanced Pharma, Inc., Houston, TX	1/22/2014	5/3/2006	No	No	No
Unique Pharmaceuticals, Ltd., Temple TX	1/24/2014	5/19/2004	No	No	Yes

 

 

Supreme Court denies last-minute request to halt Missouri execution

Mary Beth Marklein, USA TODAY 7:12 p.m. EST January 29, 2014

The U.S. Supreme Court has denied last-minute requests to halt the execution of a Missouri man convicted of killing a local jeweler two decades ago.
The high court issued a temporary stay less than three hours before Herbert Smulls was scheduled to be executed at 12:01 a.m. Wednesday.
But the court lifted the stay without explanation late Wednesday afternoon, meaning the execution can move forward.
The ruling could signal how much information states must disclose regarding the drugs they use for lethal injections in death-penalty executions.
Witnesses to the execution were told to report to the Bonne Terre prison by noon Wednesday and await further instruction from the high court.
The execution had been scheduled for 12:01 a.m. Wednesday, but that changed late Tuesday night after his lawyer, Cheryl Pilate, made last-minute pleas to spare his life.
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U.S. Supreme Court denies convicted Missouri killer's appeals--Supreme Court Stay Has been Lifted

KANSAS CITY, Mo., Jan 29 (Reuters) - The U.S. Supreme Court on Wednesday lifted a temporary stay of execution for a Missouri man convicted of killing a jewelry store owner during a 1991 robbery, denying last-minute appeals that in part challenged the drug to be used.
But there was no immediate word on whether Herbert Smulls, 56, would be executed before a death warrant expires at midnight, thanks to another stay his lawyer said remained in effect at the Eighth Circuit U.S. Court of Appeals.
Smulls was convicted of shooting jewelry-store owner Stephen Honickman to death while robbing his store in July 1991. Honickman's wife, Florence Honickman, was also shot during the attack and sustained permanent injuries.
Lawyers for Smulls have sought to block his execution on multiple grounds, arguing in part that the compounded pentobarbital Missouri plans to use may not be pure and as potent as it should be and could cause undue suffering.
Missouri and several other states have turned to compounding pharmacies, which are not regulated by the U.S. Food and Drug Administration, to acquire drugs for executions after an increasing number of pharmaceutical manufacturers objected to their drugs being used in capital punishment.
The increasing use of compounded drugs and untested drug mixes has brought renewed debate over the death penalty in the United States.
In Oklahoma, an inmate said he felt burning through his body when the lethal drugs were injected during an execution in early January. Later in the month, an Ohio man gasped and convulsed during his execution with a two-drug mix never before used in the United States.
In the Smulls case, the Eighth Circuit found on Friday that his lawyers did not propose a feasible or more humane alternative than the compounded pentobarbital or show that Missouri sought to cause him unnecessary pain by using the drug.
The Eighth Circuit separately granted a stay until the U.S. Supreme Court decides whether to hear the case. Missouri on Wednesday night asked the Supreme Court to lift that appeals court stay and allow the execution to proceed.
The Supreme Court granted Smulls the temporary stay late Tuesday, hours before his execution was to be carried out, to consider his lawyer's arguments that prosecutors had improperly eliminated a black woman as a possible juror, leaving him with an all-white jury at trial.
On Wednesday afternoon, the Supreme Court vacated the temporary stay and denied the request for a stay or to hear the appeal on the jury selection issue.
If the execution is carried out, Smulls would be the sixth person executed in the United States in 2014 and the third in Missouri since November. (Reporting by Carey Gillam and Kevin Murphy in Kansas City, Lawrence Hurley in Washington and Heide Brandes in Oklahoma City; Writing by David Bailey; Editing by Cynthia Johnston, Prudence Crowther and Mohammad Zargham).

quoted from here

AVMA Uniform horse-racing rules gaining momentum with 10 jurisdictions signing on to national reform

 Uniform horse-racing rules gaining momentum

​10 jurisdictions have signed on to national reforms

By Malinda Larkin

Posted Jan. 29, 2014 

Odds are good that the horse-racing industry will implement its own uniform medication rules in the near future.

The National Thoroughbred Racing Association sent a letter dated Sept. 30, 2013, to pari-mutuel regulators for the 38 U.S. horse-racing commissions urging them to adopt uniform national reforms involving medication regulation and enforcement, including laboratory testing. The letter was co-signed by more than 50 racetrack and industry organization leaders. The American Association of Equine Practitioners signaled its support on Dec. 6, 2013.

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January 29, 2014 SCOTUS grants stay of Missouri execution because . . . ? Sentencing Law and Policy Blog suggests that compounded drugs may not be reason for

For stay.  Read hereJanuary 29, 2014 SCOTUS grants stay of Missouri execution because . . . ?

Clayton, Dubilier & Rice Completes Investment in PharMEDium Healthcare Corporation

PR Newswire

NEW YORK, Jan. 29, 2014

NEW YORK, Jan. 29, 2014 /PRNewswire/ -- Clayton, Dubilier & Rice ("CD&R") today announced the close of an investment in PharMEDium Healthcare Corporation ("PharMEDium" or the "Company"), the leading national provider of hospital pharmacy-outsourced sterile compounding services.  Terms of the transaction were not disclosed.

PharMEDium's outsourced sterile compounding services are used by hospitals primarily to facilitate ready-to-use intravenous drug therapy to patients; it is one of the first companies to  voluntarily register with the U.S. Food and Drug Administration's (FDA) as an Outsourcing Facility and to comply with guidelines under the newly created section 503B of the Drug Quality and Security Act. Using only FDA-approved drugs, diluents and containers, the Company creates compounded sterile preparations ("CSPs"), which are not otherwise commercially available in the marketplace. PharMEDium provides CSPs in ready-to-use presentation with enhanced safety, labeling, sterility and shelf life, typically exceeding what hospital pharmacies can produce themselves.  The Company's CSPs are primarily used in: (i) intravenous pain management and anesthesia associated with surgical procedures and post-operative care, (ii) the intensive care unit (CSPs including analgesics, antibiotics, anticoagulants and electrolytes), and (iii) labor and delivery (epidurals and oxytocin).

Based in Lake Forest, Illinois, PharMEDium serves more than 2,600 acute-care hospitals, including integrated delivery systems, academic medical centers, hospital groups, and standalone urban, suburban and rural hospitals.

About Clayton, Dubilier & RiceFounded in 1978, Clayton, Dubilier & Rice is a private equity firm with an investment strategy predicated on producing financial returns through building stronger, more profitable businesses. Since inception, CD&R has managed the investment of $19 billion in 59 businesses representing a broad range of industries with an aggregate transaction value of approximately $90 billion. The Firm has offices in New York and London. For more information, please visit www.cdr-inc.com.

Excellus BlueCross BlueShield Policy on Compounded Drugs

Here

FDA’s first two warning letters since draft compounding guidances may be another way to encourage outsourcer registration.

Compounding Warning Letter Format Unchanged Since Legislation

By Derrick Gingery / Email the Author / View Full Issue
Word Count: 828 / Article # 14140128005 / Posted: January 29 2014 5:00 PM

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Executive Summary

FDA’s first two warning letters since draft compounding guidances may be another way to encourage outsourcer registration.

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