September 28, 2013 From Sentencing Law and Policy--Could execution drug difficulties and switches result in real public health problems? , headlined "Use of drug for execution might cut supply: Missouri plans on using common anesthetic in October to kill convicted murderer."

The question in the title of this post is prompted by this AP article, headlined "Use of drug for execution might cut supply: Missouri plans on using common anesthetic in October to kill convicted murderer." Here are excerpts:

The planned use of a common anesthetic in a Missouri execution is raising concerns that the anti-death penalty European Union could limit export of the drug, endangering the supply of a vital medication used every day in thousands of American hospitals and clinics.

The execution scheduled for Oct. 23 would be the first to use propofol, which is by far the nation’s most popular anesthetic. About 50 million vials are administered annually in some 15,000 locations.  That’s about four-fifths of all anesthetic procedures, according to the American Society of Anesthesiologists.  Propofol is popular because it works quickly and patients wake up faster with fewer side effects such as post-operative nausea.

Roughly 85 percent of the U.S. supply of propofol is made in Europe, where capital punishment is outlawed, by the German company Fresenius Kabi.  Export is controlled by the European Union, which prohibits trade in goods that could be used for executions.  The EU is reviewing whether to subject propofol to that rule.

If it is added to the regulation, propofol would be subject to export controls, not a complete ban, EU spokeswoman Maja Kocijancic said. Still, any change in export practices could have a drastic effect on propofol’s availability in the U.S., said Matt Kuhn, a spokesman for Fresenius Kabi USA. “It’s a real concern,” Kuhn said Friday. “And it could have enormous public health implications.”

Fresenius Kabi has launched a website specifically to address the ramifications of using propofol in a U.S. execution, http://propofol-info.com. The Food and Drug Administration is worried about any move that could affect access to propofol. FDA spokeswoman Erica Jefferson said the agency is weighing how to reach out to European officials to ensure the drug remains readily available. “We do consider this a critical need,” Jefferson said. “Without the drug, we’re concerned that surgeries would be delayed and patients would be at risk.”

Until recently, Missouri and other states with the death penalty used virtually the same three-drug protocol. That changed in recent years as drug makers stopped selling the traditional execution drugs to prison officials because they didn’t want them used for lethal injections.

Last year, the Missouri Department of Corrections turned to propofol, which made headlines in 2009 when pop star Michael Jackson died after overdosing on the drug. So far, Missouri is the only state to adopt propofol for executions, though it has not yet put anyone to death with the drug.

At one point, the shortage of execution drugs was so concerning in the state that Attorney General Chris Koster hinted that use of the gas chamber was a possible alternative. Missouri used gas for executions in the early 1900s but no longer has a working chamber.

PCCA responds to the new “Drug Quality and Security Act”--They Decided o Be Neutral!

SEPTEMBER 28, 2013 BY PROTECT MY COMPOUNDS

September 27, 2013

A bipartisan, bicameral agreement on compounding has been linked to the track-and-trace bill, known as the “Drug Quality and Security Act” (HR 3204). Leaders from the House Energy & Commerce Committee and Senate Health, Education, Labor & Pensions Committee made the announcement September 25, and released bill language late that night. Revisions to the bill were made the following day. Proponents in the House are trying to pass the bill under “suspension of the rules”, meaning they need two-thirds of the House to support the track and trace/compounding compromise.  We expect this could happen as soon as tomorrow, Saturday September 28.

In conversations with key legislators, PCCA was able to get clarification in the bill which allows compounding pharmacies to elect to become “outsourcing facilities” on a voluntary basis. This is an important change as the first draft of the bill was ambiguous on this point. With the voluntary election provision, the bill paints a clear picture as to why a pharmacy may elect to become an outsourcing facility and, more importantly, shows that the FDA cannot force a pharmacy to become an outsourcing facility because of some arbitrary rule the FDA would feel it could enforce.

There are some additional improvements made to this bill over the Senate Bill 959. HR 3204 does not provide exemptions for certain types of pharmacy practice nor does it require pharmacies practicing under 503(A) to report their compound activities to the FDA when compounding for drug shortages. PCCA would have hoped for additional revisions to 503(A) to modernize a fifteen year old piece of legislation to reflect the current state of pharmacy compounding. If the current legislation is signed into law, we will continuediscussions with our legislators about this issue.

After carefully reviewing the legislative options, we believe the bill could still have unintended consequences, however, we also believe opposing or delaying the bill would give other interests the opportunity to negatively influence the bill even further.   Therefore, PCCA has decided to be neutral regarding the “Drug Quality and Security Act”.

PCCA is committed to remaining an active participant in legislative issues and continue to represent our members and their patients to ensure access to compounded medications.

Sincerely,

Dave Sparks
CEO
PCCA

update from iacp-bill goes back to senate next week

The Compromise Compounding Bill passed via voice vote, today. It goes back to the Senate this coming week. IACP is continuing to meet with Senate offices to address language we believe does nothing for quality standards and instead jeopardizes patients' access to the compounded medications on which they depend. You can still do something about this! Go to http://lnkd.in/bMyJv98 and let your congressional contacts know why this Bill does not help you the patient. Thanks for supporting compounding pharmacists!  

breaking news

House Passes Bill That Would Add Scrutiny to Drug Makers
Read here

Comment from Dr. Kenneth Woliner

Congress often operates on the principle of "Half a loaf is better than none." IACP is opposing the bill because they don't want any FDA involvement, even if it is a "voluntary registration". As a patient, I'd be concerned because how the heck am I going to know if my doctor is injecting me with a medicine produced by a compounder that did register? As a physician, I don't see any special benefit from using a registered facility. No immunity from lawsuits caused by tainted drugs, for example. And the anti-aging clinics run by businessmen (not physicians), will still pick the cheapest supplier, not the one that registers. This bill is similar to Vietnam, where the U.S. "declared victory and left.". The Congress will pass this bill to say they did something, hoping another tragedy doesn't happen before the next election cycle. When another tragedy does happen (actually, a few more tragic events in a row), then, and only then would this do-nothing Congress actually do something on Question of the Day September 27, 2013 How can a voluntary federal law covering compounding pharmacies possibly work? Wouldn't that be like saying the Controlled Dangerous Substance Act is now voluntary?

Federal government should take wise approach to compounding regulations | Drug Store News

Federal government should take wise approach to compounding regulations | Drug Store News

NCPA Urges Passage of Compounding Reform, Drug Security Bill

NCPA Urges Passage of Compounding Reform, Drug Security Bill

My two cents: If this federal compounding legislation it will be an attorney's dream.... I would think there would be a lot of litigation resulting from it."

Public Citizen Group points out that drug manufacturers will be allowed to compound drugs if new legislation is passed to give FDA federal jurisdiction over compounding pharmacies that elect to be "outsouring facilities"

The consumer interest group Public Citizen on Friday warned that the measure could allow compounding plants to label themselves “outsourcing facilities” and escape any FDA regulation at all.

“This means even drug manufacturers that currently make FDA-approved drugs would, under this measure, have the ability to make and sell drugs to meet shortages and ‘clinical needs’ without seeking premarket approval,” Michael Carome, the director of the group’s health research group, said in a statement.

“Such approval is a critically important requirement under existing law that has helped to ensure the safety and quality of drugs for more than half a century.” 

Read more: http://thehill.com/blogs/regwatch/legislation/325249-drug-public-interest-groups-split-on-compounding-bill-#ixzz2gCMgxO3z 
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Compromise would put pharmaceutical compounders under FDA scrutiny, but make it voluntary

Robert Miller

romiller@dallasnews.com

Published: 27 September 2013 01:26 PM

Updated: 27 September 2013 01:31 PMA compromise bill that would increase federal regulation of pharmaceutical compounders has been agreed to by sponsors in the House and Senate, and could face a key vote as soon as tomorrow in the House energy and commerce committee.

Its fate, hanging in the balance over the next few days, underscores how difficult it can be to craft new regulations for businesses well-armed to fend off what they see as needless federal intrusion and costly red tape, even if safety advocates say the changes are needed to keep patients safe from deadly mistakes.

Earlier this week we looked at mounting pressure to bring compounders under tighter federal scrutiny in the wake of last year's disastrous meningitis outbreak that left dozens dead after contaminated steroids were injected in patients across the country.

Two versions had been put forth - a tougher bill that had passed a senate committee and a draft bill in the House that had drawn lighter opposition from the industry.

The compromise essentially would create a class of compounders called "outsourcing facilities" that would be regulated and inspected by the U.S. Food and Drug Administration. But the compounders would have the choice of designating themselves as outsourcing facilities, making the tougher scrutiny voluntary. In return, they'd be offered a kind of FDA seal of approval that competitors who don't submit to the scrutiny wouldn't have.

A committee report on the key provisions of the bill reads:

SEC. 102. OUTSOURCING FACILITIES. This section would add a new section 503B to the Food, Drug, and Cosmetic Act (FFDCA) allowing a facility that is engaged in the compounding of sterile drug products to register with the FDA as an outsourcing facility. Such facilities would be inspected by the FDA on a risk-based schedule and required to follow current good manufacturing practices (cGMPs) in addition to having to meet other standards and requirements. SEC. 103. PENALTIES. This section would add several prohibited acts associated with compounded drugs, including the intentional falsification of prescriptions for such products. SEC. 104. REGULATIONS. This section would require the Secretary to follow the formal rulemaking process when promulgating regulations to implement this title. SEC. 105. ENHANCED COMMUNICATION. This section would require the Secretary to facilitate meaningful communication between the agency and the State boards of pharmacy about concerns raised, or actions taken, against compounding pharmacies.

But The Houston-based International Academy of Compounding Pharmacists opposed the initial Senate bill and continues to have "many concerns" about the compromise, according to a post to members on its website.

I've got calls into several Texans who serve on the Energy and Commerce Committee, and will update this post when I hear back about who is supporting what.In a sign that the compromise has the support of the GOP leadership, the committee posted a link to more than a dozen letters sent by supporters of the compromise bill.