Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, May 29, 2014
Question of the Day May 29, 2014 How quick will someone file a lawsuit against Texas Attorney General Greg Abbott's position on non disclosure of the compounding pharmacy who makes execution drugs? Will the AG's decision stand up in the Texas Courts? What about in the 5th Circuit (federal) court? Will the U.S. Supreme Court ultimately decide this issue? Does a potental threat to a compounding pharmacy outweight disclosure?
“Serious questions surround this about-face, including why our Attorney General, who once championed transparency, is suddenly now supporting secretive government practices,” Maurie Levin, an attorney for death row inmates, said in a statement.
In a reversal of his previous rulings, Texas Attorney General Greg Abbott on Thursday decided that the Texas prison system can keep secret from the public information about pharmacies that provide execution drugs.
The ruling cited an assessment by the state Department of Public Safety that determined drug suppliers could be subject to “real harm.
In an interview with The Texas Tribune, DPS Director Steve McCraw confirmed Thursday that his agency has investigated threats made to pharmacies about lethal drugs provided to the state prison system’s execution.
“We did review threats that were made to pharmacies,” McCraw said. “It did have to do with execution drugs and it was information provided to us and that we looked at.”
Abbott, in his ruling, said that the DPS “threat assessment” was the proof needed to keep private information about suppliers of lethal drugs used by the Texas Department of Criminal Justice. The ruling allowing secrecy is noteworthy because it was made in the midst of Abbott's campaign for Texas governor against Democratic Sen. Wendy Davis and because in three prior rulings, Abbott has ruled for transparency when it comes to execution information. Calls to Abbott's state office and his campaign office were not immediately returned Thursday.
In his ruling, Abbott wrote that based on the DPS assessment and his agency's review, "we find the department must withhold the identifying information of the pharmacy and pharmacist."
McCraw declined to say how many threats had been made to pharmacies, how many were investigated or whether they were credible.
“I’m not going to get into that discussion with you,” McCraw said.
continue to read here
The ruling cited an assessment by the state Department of Public Safety that determined drug suppliers could be subject to “real harm.
In an interview with The Texas Tribune, DPS Director Steve McCraw confirmed Thursday that his agency has investigated threats made to pharmacies about lethal drugs provided to the state prison system’s execution.
“We did review threats that were made to pharmacies,” McCraw said. “It did have to do with execution drugs and it was information provided to us and that we looked at.”
Abbott, in his ruling, said that the DPS “threat assessment” was the proof needed to keep private information about suppliers of lethal drugs used by the Texas Department of Criminal Justice. The ruling allowing secrecy is noteworthy because it was made in the midst of Abbott's campaign for Texas governor against Democratic Sen. Wendy Davis and because in three prior rulings, Abbott has ruled for transparency when it comes to execution information. Calls to Abbott's state office and his campaign office were not immediately returned Thursday.
McCraw declined to say how many threats had been made to pharmacies, how many were investigated or whether they were credible.
“I’m not going to get into that discussion with you,” McCraw said.
continue to read here
This Pharmacist Is One of Greg Abbott’s Biggest Donors. Here’s Why.--Massive Conflicts between current job and one of his biggest campaign contributors
Greg Abbott, the Republican attorney general of Texas, has many of the usual suspects funding his gubernatorial campaign: Energy tycoons, construction company magnates, leveraged buyout moguls, sports team owners. But one of his biggest backers hails from an industry not typically known for bankrolling political campaigns. J. Richard “Richie” Ray is the owner of a compounding pharmacy, one of those loosely regulated entities that have been mixing up lethal injection drug cocktails for prisons as these pharmaceuticals have become harder and harder to obtain. According to a new report from the nonprofit Texans for Public Justice, Ray, the owner of Richie’s Specialty Pharmacy in Conroe, Texas, has given Abbott $ 350,000 to help him defeat democratic challenger Wendy Davis.
Ray’s big investment in Abbott comes as death row inmates and good-government groups are trying to force Texas to disclose the supplier of its lethal injection drugs, thought to be a compounding pharmacy. The pharmacies themselves are under fire for selling tainted and mislabled medicine that has killed dozens of people in recent years. During Abbott’s tenure as AG, he has already taken on one Texas compounder, ApotheCure, after three people in Oregon died after taking painkillers from the pharmacy that were eight times more potent than the label indicated. (In 2012, Abbott settled state civil charges against the company.) Last summer, tainted medicine from an Austin compounding pharmacy caused blood infections in 17 people; two deaths are suspected to be related to the products, which are still under investigation.
Abbott is also in the middle of a pitched legal battle over whether the state has to identify the supplier of its lethal injection drugs. Over the past several years, international pharma companies have started refusing to sell execution drugs, including pentobarbital, to US prisons for use in lethal injections, and the EU has banned their export. This has left state prisons desperate to find replacement drugs to continue moving the machinery of death. After several states were caught illegally importing the drugs from abroad, state officials have tried obtaining their execution drugs from compounding pharmacies, which can legally mix them up but that have been plagued with problems like those in Texas. Defense lawyers have argued that their condemned clients have a right to know what they’re going to be injected with to ensure that the executions will not violate the Eighth Amendment ban on cruel and unusual punishment, and they’ve cited the well-documented problems with drugs produced by compounders in their challenges. The botched execution of Clayton Lockett in Oklahoma only reinforced those claims.
In October, in response to a formal request under the state’s open-records law, staff who handle such requests in the AG’s office said Texas law required disclosure of the execution drug supplier, a move that resulted in the exposure of Woodlands Compounding Pharmacy as the state’s lethal injection supplier. Woodlands promptly quit supplying execution drugs. As a result, the state is now fighting disclosure of the name of its new supplier, and Abbott is caught in the middle, with his lawyers arguing in state and federal court that the name of the pharmacy doesn’t have to be disclosed, even as his open-records staff say it does.
In the midst of all this controversy, Richie Ray has become a major donor Abbott’s campaign. He gave $ 100,000 in June 2013, just before the state bought several doses of compounded pentobarbital from a compounding pharmacy. (By comparison, Ray has given only a little more than $ 40,000 to Rick Perry’s campaigns.) Ray’s pharmacy is not supplying execution drugs to the state, according to the Texans for Public Justice report, apparently because his pharmacy isn’t certified as a “sterile” facility. However, Richie’s is a member of the Professional Compounding Centers of America (PCCA), a Houston-based national trade group that not only owns the lab that tested some of the state’s compounded execution drugs for purity but also sold Woodlans the raw materials to make one of the drugs.
Ray himself is active in fighting tougher regulation of compounding pharmacies. He’s the director of the Texas Pharmacy Association PAC and chairman of the International Academy of Compounding Pharmacists’ federal PAC. His employees are the top donors to the campaign of Sen. John Barasso (R-WY), a doctor and the Senate’s leading defender of compounding pharmacies like ApotheCure.
Given the massive conflicts between his current job and one of his biggest campaign contributors, Abbott can only hope that defense lawyers manage to drag out the legal battles over lethal injection long enough for him to get elected in November.
quoted from Mother Jones found here
Ray’s big investment in Abbott comes as death row inmates and good-government groups are trying to force Texas to disclose the supplier of its lethal injection drugs, thought to be a compounding pharmacy. The pharmacies themselves are under fire for selling tainted and mislabled medicine that has killed dozens of people in recent years. During Abbott’s tenure as AG, he has already taken on one Texas compounder, ApotheCure, after three people in Oregon died after taking painkillers from the pharmacy that were eight times more potent than the label indicated. (In 2012, Abbott settled state civil charges against the company.) Last summer, tainted medicine from an Austin compounding pharmacy caused blood infections in 17 people; two deaths are suspected to be related to the products, which are still under investigation.
Abbott is also in the middle of a pitched legal battle over whether the state has to identify the supplier of its lethal injection drugs. Over the past several years, international pharma companies have started refusing to sell execution drugs, including pentobarbital, to US prisons for use in lethal injections, and the EU has banned their export. This has left state prisons desperate to find replacement drugs to continue moving the machinery of death. After several states were caught illegally importing the drugs from abroad, state officials have tried obtaining their execution drugs from compounding pharmacies, which can legally mix them up but that have been plagued with problems like those in Texas. Defense lawyers have argued that their condemned clients have a right to know what they’re going to be injected with to ensure that the executions will not violate the Eighth Amendment ban on cruel and unusual punishment, and they’ve cited the well-documented problems with drugs produced by compounders in their challenges. The botched execution of Clayton Lockett in Oklahoma only reinforced those claims.
In October, in response to a formal request under the state’s open-records law, staff who handle such requests in the AG’s office said Texas law required disclosure of the execution drug supplier, a move that resulted in the exposure of Woodlands Compounding Pharmacy as the state’s lethal injection supplier. Woodlands promptly quit supplying execution drugs. As a result, the state is now fighting disclosure of the name of its new supplier, and Abbott is caught in the middle, with his lawyers arguing in state and federal court that the name of the pharmacy doesn’t have to be disclosed, even as his open-records staff say it does.
In the midst of all this controversy, Richie Ray has become a major donor Abbott’s campaign. He gave $ 100,000 in June 2013, just before the state bought several doses of compounded pentobarbital from a compounding pharmacy. (By comparison, Ray has given only a little more than $ 40,000 to Rick Perry’s campaigns.) Ray’s pharmacy is not supplying execution drugs to the state, according to the Texans for Public Justice report, apparently because his pharmacy isn’t certified as a “sterile” facility. However, Richie’s is a member of the Professional Compounding Centers of America (PCCA), a Houston-based national trade group that not only owns the lab that tested some of the state’s compounded execution drugs for purity but also sold Woodlans the raw materials to make one of the drugs.
Ray himself is active in fighting tougher regulation of compounding pharmacies. He’s the director of the Texas Pharmacy Association PAC and chairman of the International Academy of Compounding Pharmacists’ federal PAC. His employees are the top donors to the campaign of Sen. John Barasso (R-WY), a doctor and the Senate’s leading defender of compounding pharmacies like ApotheCure.
Given the massive conflicts between his current job and one of his biggest campaign contributors, Abbott can only hope that defense lawyers manage to drag out the legal battles over lethal injection long enough for him to get elected in November.
quoted from Mother Jones found here
Missouri Attorney General Pitches Plan To Avoid Botched Lethal Injections
By Carey Gillam
May 29 (Reuters) - Missouri should fund and operate its own drug laboratory to mix lethal injections for executions, a move that could help circumvent the problems it and other states are having obtaining the drugs they need, the state's top prosecutor said on Thursday.
Setting up a state laboratory would take compounding pharmacies out of the system, and eliminate the secrecy about where lethal injections drugs are coming from, said Missouri Attorney General Chris Koster.
"As a matter of policy, Missouri should not be reliant on merchants whose identities must be shielded from public view or who can exercise unacceptable leverage over this profound state act," Koster said in a speech to Bar Association of Metropolitan St. Louis conference.
continue to read here
May 29 (Reuters) - Missouri should fund and operate its own drug laboratory to mix lethal injections for executions, a move that could help circumvent the problems it and other states are having obtaining the drugs they need, the state's top prosecutor said on Thursday.
Setting up a state laboratory would take compounding pharmacies out of the system, and eliminate the secrecy about where lethal injections drugs are coming from, said Missouri Attorney General Chris Koster.
"As a matter of policy, Missouri should not be reliant on merchants whose identities must be shielded from public view or who can exercise unacceptable leverage over this profound state act," Koster said in a speech to Bar Association of Metropolitan St. Louis conference.
continue to read here
Breaking News! Abbott switches mind on death drug secrecy
By Mike Ward
May 29, 2014 | Updated: May 29, 2014 8:33pm
Comments
Share
- Email email_share|article-5514843|article-page-share-menu|1
- Reddit reddit_share|article-5514843|article-page-share-menu|1
- Facebook facebook_share|article-5514843|article-page-share-menu|1
- Twitter twitter_share|article-5514843|article-page-share-menu|1
- Google + google_share|article-5514843|article-page-share-menu|1
- Pinterest pinterest_share|article-5514843|article-page-share-menu|1
- Print this Article
- Jump To Comments
AUSTIN - In a surprise legal about-face, Attorney General Greg Abbott on Thursday ruled that state prison officials no longer have to tell the public where they obtain drugs used to execute condemned criminals.
Abbott's decision falls in line with other states that have sought to keep secret the source of their lethal drugs, to keep death-penalty opponents from pressuring suppliers to quit selling to execution chambers. His decision reversed three rulings since 2010 that had mandated the information about the suppliers be made public.
Abbott, the Republican nominee for governor in the state that operates the nation's busiest death chamber, said in his five-page decision that he was swayed to allow secrecy by a "threat assessment" from Steve McCraw, director of the Texas Department of Public Safety, that disclosure of details could endanger suppliers.
In arguing for the secrecy, officials with the Texas Department of Criminal Justice, which conducts the executions, insisted pharmacies supplying the drug pentobarbital used in executions could be subject to death threats if their identity was known - an assertion an Associated Press investigation could not validate as true.
Opposition raised
Prison officials applauded the ruling, but attorneys for condemned convicts and open-government advocates warned it will unnecessarily shield details of Texas' ultimate punishment and could cover up mistakes in executions.
"It is deeply disturbing and frankly quite shocking that the highest law enforcement official in the state has suddenly reversed his position on disclosure when it comes to lethal injection, particularly considering the horrifically botched execution in Oklahoma last month that was the direct result of secrecy surrounding the process," said attorney Maurie Levin, who has challenged the secrecy in recent months in representing execution-bound convicts.
An Oklahoma convict did not die after the lethal drugs were administered, possibly because of a vein problem, and died of a heart attack. An investigation continues.
Levin and other attorneys have tried unsuccessfully to get access to drug information so they can validate the purity of the drugs many states, including Texas, are buying from so-called compounding pharmacies. These manufacturers are more lightly regulated than major pharmaceutical companies.
Drugs unavailable
In recent years, most of these manufacturers have stopped supplying drugs used in executions because of public pressure or because they are based in Europe, where the death penalty is not used.
continue to read here
Abbott's decision falls in line with other states that have sought to keep secret the source of their lethal drugs, to keep death-penalty opponents from pressuring suppliers to quit selling to execution chambers. His decision reversed three rulings since 2010 that had mandated the information about the suppliers be made public.
In arguing for the secrecy, officials with the Texas Department of Criminal Justice, which conducts the executions, insisted pharmacies supplying the drug pentobarbital used in executions could be subject to death threats if their identity was known - an assertion an Associated Press investigation could not validate as true.
Opposition raised
Prison officials applauded the ruling, but attorneys for condemned convicts and open-government advocates warned it will unnecessarily shield details of Texas' ultimate punishment and could cover up mistakes in executions.
"It is deeply disturbing and frankly quite shocking that the highest law enforcement official in the state has suddenly reversed his position on disclosure when it comes to lethal injection, particularly considering the horrifically botched execution in Oklahoma last month that was the direct result of secrecy surrounding the process," said attorney Maurie Levin, who has challenged the secrecy in recent months in representing execution-bound convicts.
An Oklahoma convict did not die after the lethal drugs were administered, possibly because of a vein problem, and died of a heart attack. An investigation continues.
Levin and other attorneys have tried unsuccessfully to get access to drug information so they can validate the purity of the drugs many states, including Texas, are buying from so-called compounding pharmacies. These manufacturers are more lightly regulated than major pharmaceutical companies.
Drugs unavailable
In recent years, most of these manufacturers have stopped supplying drugs used in executions because of public pressure or because they are based in Europe, where the death penalty is not used.
continue to read here
House Committee Report would increase FDA monies for compounding activities by $12,000,000
Pharmacy Compounding.—The Committee provides an increase of $12,000,000 for pharmacy compounding activities specified in the Drug Quality and Security Act (DQSA). The Committee urges FDA to complete inspections of compounding facilities that clearly fall within the agency’s jurisdiction and take all necessary enforcement actions needed to promote the safety of the drug supply chain. For those pharmacies unaffected by DQSA, state boards of pharmacy are the proper regulator of state licensed pharmacies and should remain so. The Committee will continue to monitor FDA spending and oversight over compounding pharmacies to ensure the intent of both funding and legislation approved by Congress is observed. (Additional information here.)
quoted from FDA Law blog found here
quoted from FDA Law blog found here
Must Read! FDA Law Blog--As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List Grows
By Kurt R. Karst –
On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along with an accompanying report. The House Appropriations Committee vote follows a May 22nd mark-up session by the U.S. Senate Committee on Appropriations of its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389). The Senate Committee approved that measure by a 16-14 vote, along with an accompanying report, and they will go on to the full Senate for consideration. As is typical of FDA appropriations bills and reports, lawmakers heap on various recommendations and directives. We’ve gone ahead an extracted those items from each of the documents and added some links to background information. We’re not going to get into all of the appropriations funding numbers. Instead, we’ll leave that to the folks over at the Alliance for a Stronger FDA (see here).
House Fiscal Year 2015 FDA Appropriations Bill & Report
In what seems to be an effort to strongarm FDA into action on finalizing a guidance document on abuse deterrence opioid development (see our previous post here), Section 734 of the House bill provides:
continue to read here
On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along with an accompanying report. The House Appropriations Committee vote follows a May 22nd mark-up session by the U.S. Senate Committee on Appropriations of its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389). The Senate Committee approved that measure by a 16-14 vote, along with an accompanying report, and they will go on to the full Senate for consideration. As is typical of FDA appropriations bills and reports, lawmakers heap on various recommendations and directives. We’ve gone ahead an extracted those items from each of the documents and added some links to background information. We’re not going to get into all of the appropriations funding numbers. Instead, we’ll leave that to the folks over at the Alliance for a Stronger FDA (see here).
House Fiscal Year 2015 FDA Appropriations Bill & Report
In what seems to be an effort to strongarm FDA into action on finalizing a guidance document on abuse deterrence opioid development (see our previous post here), Section 734 of the House bill provides:
continue to read here
Subscribe to:
Posts (Atom)