Testimony in MA that NECC was an accident waiting to happen and the compounding industry is rife with potential conflicts of interest

Montigny misses mark

January 28, 2013

Sen. Mark Montigny (D-New Bedford), who often targets Big Pharma and its lobbying efforts in his perpetual search for bad guys, may have actually found a better target in Little Pharma — those compounding pharmacies that have grown and grown and yet remained under the radar screen.

That is until 44 people died and 678 were sickened by fungal meningitis traced to the New England Compounding Center, which went virtually unregulated and uninspected until it was too late.

So last week Montigny chaired a meeting of the Senate Post Audit and Oversight Committee at which Dr. Sarah Sellers, a former compounding pharmacist and former Food and Drug Administration official testified that the NECC case was “an accident waiting to happen” and that the compounding industry is rife with potential conflicts of interest.

Montigny, of course, chose not to focus on the obvious — that the state Board of Registration in Pharmacy was itself rife with such conflicts and failed in its responsibility to regulate compounding pharmacies here. No, he chose to zero in on his favorite bete noir:

“When we allow special interests to ply their trade so successfully in Washington and in state capitols, the outcome is inevitable, and in this case deadly,” he insisted.

Yes it’s all about the lobbyists — really!

How about public officials who weren’t doing their jobs? How about greedy owners who even as people were dying and NECC was in bankruptcy proceedings were looting its treasury, according to their bankruptcy court filings?

It’s all shameful, but as usual the senator misses the point.

Source found here

American Society of Pharmacy Law Track and Annual Business Meeting: Mark the Date

ASPL Pharmacy Law Track and Annual Business Meeting

American Society for Pharmacy Law Track
ASPL will once again be sponsoring a series of sessions on Pharmacy Law at APhA 2013 in Los Angeles, CA March 1-4.  For more information about the APhA 2013 annual meeting, go to www.aphameeting.org.

Pharmacy Law Track:

• Case Law Update
• Legislative & Regulatory Update
• Hot Law Topics
• Warning: What You Don't Know Can Hurt You — Understanding the Consequences of State Board of Pharmacy Actions
• FDA Update
• HIPAA and HITECH: New Requirements for Privacy and Security
• Mitigating Your Legal Risk: Challenges to Compliance in the Current Regulatory Framework
• Pharmacy Social Media Boot Camp: Legal Issues

ASPL Annual Business Meeting
Please join us for the Annual Business Meeting and Reception to be held on Saturday, March 2, 2013, at 6:00 pm at the JW Marriott Hotel.

Florida State Surgeon General Tours Compounding Pharmacy

Contact: DOH Communications
(850) 245- 4111

STATE SURGEON GENERAL TOURS COMPOUNDING PHARMACY IN PENSACOLA
~Representative Clay Ingram tours Pensacola Apothecary with Dr. Armstrong~

TALLAHASSEE- Florida Surgeon General and Secretary of Health Dr. John Armstrong was recently joined by Representative Clay Ingram, R-Pensacola, in a tour of Pensacola Apothecary, a compounding pharmacy in Pensacola, Fla. The local pharmacy provides services to Northwest Florida physicians and specializes in formulating and customizing medications to meet the special health needs of patients and to assist where certain medications are not available. With recent discussions regarding compounding practices in the state and across the nation, this tour presented a unique opportunity to gain first-hand knowledge of the practice and to work with the Board of Pharmacy in its ongoing discussions of changes to best protect all Floridians.

“Pensacola Apothecary serves as an industry standard for quality of service and safe practices,” said Dr. Armstrong. “These strict quality standards should be the benchmark for all compounding pharmacies so that patients in Florida receive safe compounded medications.”

Supervising pharmacist Christopher Schulte manages Pensacola Apothecary, a community and special parenteral and enteral pharmacy. A parenteral and enteral pharmacy is licensed to compound sterile medications such as intravenous “IV” therapy and nutrition, irrigation solutions, feeding tubes and other sterile products such as eye drops. Pensacola Apothecary opened its doors in 2003 and is Northwest Florida’s only Pharmacy Compounding Accreditation Board (PCAB) accredited pharmacy, the highest quality and safety standards in the profession.

“Pensacola is fortunate to be served by one of the state’s leaders in safe, high-quality compounding,” said Rep. Clay Ingram. “I personally saw the extraordinary measures taken by Pensacola Apothecary to ensure that patients are protected, and that kind of commitment to safety sets a wonderful example for other compounding pharmacies in Florida.”

National conversations have emerged regarding the safety of compounded medications as the result of the fungal meningitis caused by contaminated injectable products compounded at the New England Compounding Center in Framingham, Mass. The Florida Department of Health, along with the Florida Board of Pharmacy will continue to review current regulation of Florida’s pharmacies to identify measures for improvement. Results from a mandatory compounding practice survey have recently been released and will serve as a guide to future rulemaking in order to protect patients without creating unduly burdensome regulation.

DOH protects, promotes and improves the health of all people in Florida through integrated state, county and community efforts.

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Aren't We All In This Boat Together And All Looking For the Right Solution? APhA's Position is Refreshing.

One of my favorite times to write is late at night when the house is quite.  Actually it is a habit.  While working at the U.S. Attorney's Office most nights  I had to stay up and work after everyone else at my house had gone to bed.  Deadlines come fast and furious in the federal government's legal world.  Long hours are the norm.   Attorneys do their best not to miss deadlines for a number of reasons--there are the ethical reasons--sanctions from the court, causing your side to lose, etc.  As AUSA(Assistant United States Attorneys)  there was another reason.  When you are sworn in as an AUSA you take an oath of office--this is after all the background checks and security clearances-deeming you worthy of these positions.  The oath is a pledge that you will represent and defend the United States of America.  Most AUSAs, if not all,  take this oath extremely serious.  After all isn't it extremely serious to represent and defend  one's country.   Does that, however, make one pro-government?  I suppose that depends on what one means by the use of the word pro-government?  Does pro-government always mean that you believe in more, bigger government?  No. It does not.  Pro-government can also mean you believe in your government--the United States of America-and that you will represent and defend it as necessary.
At times as an AUSA you might be asked to defend a law that you personally did not believe in.  That was the job you were paid to do. A lot of times you are required to advocate a position that is not your personal belief, but again that is what you are required to do even when you thought it made you look disingenuous.

Likewise, does anti-government mean you hate government of any kind?  Does it mean you prefer state government over the federal government to regulate certain areas?  Does it mean government can be big as long as it is state government doing the regulating and not the federal government?  Again, I think different people have different ideas of what these terms mean.  I know I have been labeled by some as pro-government because I spent a great part of my legal career representing the United States of America and defending the Constitution and the rights it provides.  I took my job very, very seriously as an AUSA, and I tried to honor the oath I swore to,  I also represented the great state of Oklahoma as an Assistant Attorney General and took an oath there also.  People don't seem to focus on that job.  Does that job make me pro-state government?  How do you mesh the two and come up with the right label for me if you are simply basing it on where I worked and nothing else?  Is it really fair to label me at all simply because I have a background in federal and state jurisdiction and understand the legal ins and outs and some of the legal challenges of both?

There are both sound arguments for and against the FDA taking over all or a bigger part of regulating compounding.  Similarly, there are sound arguments for and against the states continuing to regulate compounding.  APhA's position announced on the blog earlier today was refreshing.  It was refreshing to see thatAPhA's is considering options even though it involves change. It is refreshing that APhA wishes to continue the dialogue with the FDA and work to find the best solution.

The point of this blog is and always has been to educate, inform and open up the dialogue regarding issues in the compounding world.  Is this blog meant to be negative toward compounding? Absolutely not, but it is meant to present multiple sides and views.  The recent events of NECC have caused a negative spin on compounding. That may be unfortunate, but it is the reality. On a recent post when I asked readers to comment on the positive of compounding, I got no responses despite the post being well read.  I still welcome any and all positive stories that readers want to share about compounding.
I hope that others will be open to new ideas and solutions to make the compounding world a better safer place no matter who ultimately is in charge of regulating it.