November 27, 2012

Compounding, Again

FDA • Tags: CDC, Compounded Drugs, Compounding Pharmacies, Congress, Contaminated Injections, Drug Manufacturer, Drugs, FDA Compliance, Food Drug and Cosmetic Act, Jon Weinrieb, Margaret Hamburg, Marketing, Meningitis Outbreak, Pharmacies, Tish Pahl

By Tish Eggleston Pahl

The election is over, cabinet re-shuffling has begun, and hopefully you properly prepared and stored your food and avoided poisoning family and friends over the Thanksgiving holiday.  As you can imagine, food preparation at a food and drug law firm is a very serious business.  We regularly swap favorite turkey brining and stuffing recipes and remind each other about safe thawing practices.  I personally recommend America’s Test Kitchen’s vodka pie crust and the Pioneer Woman’s butternut squash puree.

Moving from foods to drugs, we continue to follow the ongoing investigation into the New England Compounding Company (NECC).  As my partner, Jon Weinrieb, wrote, FDA Commissioner Margaret Hamburg testified on November 14 and 15 before the House Energy and Commerce Subcommittee on Oversight and Investigations and the Senate Committee on Health, Education, Labor and Pensions.  The FDA has been seeking to define the line between the traditional practice of pharmacy (in theory regulated by State Boards of Pharmacy) and drug manufacturing (which FDA should regulate).  Today, the FDA announced plans for a public meeting on the matter. It will also accept comments to explore these issues.

The public meeting will take place on December 19 and will be webcast.  The notice states that onsite registration begins at 2 p.m. on December 19 on a first-come, first-served basis and that the meeting will be from 3 to 5 p.m.  I’ve covered lots of FDA public meetings over the years (the ones in the wireless dead zone of the NHTSA hearing room below L’Enfant Plaza were especially memorable), and I’ve never seen one lasting only 2 hours.  Fortunately, FDA is also accepting public comments until January 18, 2013.

Echoing some of Commissioner Hamburg’s earlier remarks, the agency is focusing upon defining “traditional pharmacy compounding that should be primarily overseen by the States and higher risk non-traditional pharmacy compounding that would require compliance with Federal standards. . . .  In recognition of the States’ role, the FDA has also reached out to its State partners by inviting representatives from all 50 States to an intergovernmental meeting.”  The two-hour public meeting will follow the State intergovernmental meeting.

The agency seeks comment on three questions:

• Given existing authorities and resources, are the States currently able to provide the needed oversight of pharmacy compounding and consumer protection?

• What should the Federal role be in regulating higher risk pharmacy compounding such as compounding high-volumes of drugs for interstate distribution?  Is there a way to re-balance Federal and State participation in the regulation of pharmacy compounding that would better protect the public health?  What strategies should be developed to further strengthen Federal/State communications?

• Do you see a role for the States in enforcing a Federal standard for “non-traditional” compounding?  If so, what role?  What factors would affect a decision by your State to take on such responsibility?

Given the breadth and complexity of these questions and the short, 2-hour time frame, any thoughtful response should be submitted in written comments.  We’ll be watching the public meeting and live-tweeting i

Compounding, Again

November 27, 2012

By Tish Eggleston Pahl

The election is over, cabinet re-shuffling has begun, and hopefully you properly prepared and stored your food and avoided poisoning family and friends over the Thanksgiving holiday.  As you can imagine, food preparation at a food and drug law firm is a very serious business.  We regularly swap favorite turkey brining and stuffing recipes and remind each other about safe thawing practices.  I personally recommend America’s Test Kitchen’s vodka pie crust and the Pioneer Woman’s butternut squash puree.

Moving from foods to drugs, we continue to follow the ongoing investigation into the New England Compounding Company (NECC).  As my partner, Jon Weinrieb, wrote, FDA Commissioner Margaret Hamburg testified on November 14 and 15 before the House Energy and Commerce Subcommittee on Oversight and Investigations and the Senate Committee on Health, Education, Labor and Pensions.  The FDA has been seeking to define the line between the traditional practice of pharmacy (in theory regulated by State Boards of Pharmacy) and drug manufacturing (which FDA should regulate).  Today, the FDA announced plans for a public meeting on the matter. It will also accept comments to explore these issues.

The public meeting will take place on December 19 and will be webcast.  The notice states that onsite registration begins at 2 p.m. on December 19 on a first-come, first-served basis and that the meeting will be from 3 to 5 p.m.  I’ve covered lots of FDA public meetings over the years (the ones in the wireless dead zone of the NHTSA hearing room below L’Enfant Plaza were especially memorable), and I’ve never seen one lasting only 2 hours.  Fortunately, FDA is also accepting public comments until January 18, 2013.

Echoing some of Commissioner Hamburg’s earlier remarks, the agency is focusing upon defining “traditional pharmacy compounding that should be primarily overseen by the States and higher risk non-traditional pharmacy compounding that would require compliance with Federal standards. . . .  In recognition of the States’ role, the FDA has also reached out to its State partners by inviting representatives from all 50 States to an intergovernmental meeting.”  The two-hour public meeting will follow the State intergovernmental meeting.

The agency seeks comment on three questions:

• Given existing authorities and resources, are the States currently able to provide the needed oversight of pharmacy compounding and consumer protection?

• What should the Federal role be in regulating higher risk pharmacy compounding such as compounding high-volumes of drugs for interstate distribution?  Is there a way to re-balance Federal and State participation in the regulation of pharmacy compounding that would better protect the public health?  What strategies should be developed to further strengthen Federal/State communications?

• Do you see a role for the States in enforcing a Federal standard for “non-traditional” compounding?  If so, what role?  What factors would affect a decision by your State to take on such responsibility?

Given the breadth and complexity of these questions and the short, 2-hour time frame, any thoughtful response should be submitted in written comments.  We’ll be watching the public meeting and live-tweeting it!

Source found here

Hospital Pharmacies Step Up Compounding Efforts In Wake Of Meningitis Outbreak

By Fred Bever November 28, 2012 Updated Nov 28, 9:11 am

BOSTON — Physicians and hospitals are scrambling for the specialty compounds produced by the New England Compounding Center in Framingham and a related company, Ameridose. Both companies closed following the national meningitis outbreak caused by contaminated steroids made by NECC that killed 36 people and sickened 510.

Some hospitals in Massachusetts are responding in ways that could be better for patients.

MGH Pharmacy Goes 24/7

Patients at Massachusetts General Hospital take some 400,000 doses of medication every month — 4.8 million a year. And until two months ago, close to a million of them were compounded by third-party vendors, such as NECC and, even more, Ameridose. Now, most of that work has been brought in house to MGH’s central pharmacy.

It’s a clinical beehive where technicians in varying surgical outfits fill IV bags and sort syringes. Behind air-locked doors, more workers sit under high-tech bays — or “hoods” — compounding sterile medications.

Just outside this “clean room,” lead technician Meghan Federico sorts test tubes.

“It’s what we put our samples in, specimen samples, to test for sterility,” Federico said.

No doubt this was a busy place before Ameridose was closed. But now, this lab is really humming.

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Malpractice bills spawn rift over meningitis settlement

Nov. 27, 2012  

An attorney for meningitis victims worries that lame-duck Michigan legislators will enact a series of medical malpractice bills that would make it harder for clients to recover damages.

Supporters of the legislation say the bills won't impact meningitis cases.

The bills would expand immunity for medical professionals and place limits on damages plaintiffs could receive.

"Any changes to malpractice standards will make it more difficult for steroid patients to bring a case," said Marc Lipton, who is representing Howell meningitis victim Brenda Bansale.

The bills have awaited action by the Senate Insurance Committee for several months.

State Sen. Joe Hune, the committee chairman, said the bills "wouldn't involve the meningitis cases."

"We've been meeting with trial lawyers and members of the medical profession," said Hune, R-Hamburg Township. "Hopefully, we'll be coming to some kind of consensus."

At least two of four bills could be released as soon as today with floor debate and a potential vote coming as soon as Thursday, Hune said.

A spokeswoman for Senate Majority Leader Randy Richardville, R-Monroe, said it was hoped they would all come to the floor before the Senate adjourns for the year.

"There is a desire to see it happen," Richardville spokeswoman Amber McCann said. "There's a laundry list of items awaiting action, and medical malpractice is on that list."

Of the four bills, S.B. 1116 would exempt medical professionals from liability if they acted with "reasonable good faith" based on medical practices and patients' best interest.

While this is considered the centerpiece of malpractice reform, Hune said the bill "probably wouldn't be released" from committee today.

Another bill, S.B. 1115, would place limits on damages issued for the loss of household services. That bill caused a particular concern for Lipton.

"My client has been disabled for three months. That means she doesn't do things that she normally does like cooking, cleaning and balancing the checkbook. There's an economic value to that," Lipton said.

Among the other bills, S.B. 1117, tightens requirements for expert witnesses in malpractice cases while S.B. 1118 limits the time frame for interest on damages.

A fifth bill, dealing with emergency room cases, has yet to be debated by the committee.

Bansale is among those seeking damages from New England Compounding Pharmacy Inc. Health officials believe the contaminated steroids were mixed at the now-closed Massachusetts facility. Congress is debating whether to expand the U.S. Food and Drug Administration's ability to regulate similar facilities.

Michigan law restricts victims of defective FDA-approved drugs from suing drug manufacturers, though legal professionals believe the compounding facility can be sued because its products are exempt from FDA review.

Hune earlier joined Gov. Rick Snyder and Attorney General Bill Schuette in calling for the Bureau of Health Professionals to suspend the compounding pharmacy's license, which would prevent it from marketing any more products in Michigan.

The Michigan Department of Community Health has linked four deaths in Livingston County to the meningitis outbreak. In all, the department says 178 cases, including 10 deaths, have been connected to the outbreak in Michigan.

Contact Daily Press & Argus reporter Wayne Peal at (517) 548-7081 or at wpeal@gannett.com.

Source found here