Under Markey's Proposed Bill Not Much Would Change

Bill Would Further Involve FDA in Drug Compounding Oversight

By Edward Lamb, About.com GuideNovember 6, 2012

U.S. Rep. Ed Markey, whose Massachusetts district is home to the town where the New England Compounding Center prepared and shipped the tainted steroid injections blamed for causing a deadly fungal meningitis outbreak, has made good on his promise to introduce legislation to give the U.S. Food and Drug Administration additional roles in overseeing drug compounding.

The bill, filed on Nov. 2, 212, is titled the Verifying Authority and Legality in Drug (VALID) Compounding Act,

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No Eye Surgery Infections Yet from Fungal Meningitis Drug Contamination

By Marc Grossman, OD, LAc, November 6th, 2012

There have not been any reported cases so far of eye infection in eye surgery patients who received medications from the New England Compounding Pharmacy (NECC); however, other types of patients have contracted fungal meningitis. Several NECC products were recalled after patients receiving drug injections for back pain became ill. More than 400 people in 15 states developed fungal infections that have been traced to products from NECC, and more than 29 people have died.

The compounding pharmacy is supposed to ship sterile products that are free of bacteria, fungi, viruses, and contaminants. Investigators found contamination that was sometimes even visible to the naked eye. Compounding pharmacies operate in a legal gray area that includes both state and federal laws. Pharmacies are regulated by state pharmacy boards, but the FDA steps in when a significant situation arises. Sometimes the federal courts have decided the FDA overstepped its boundaries in handling problems at compounding pharmacies. The FDA is calling for new laws to make clear the federal governmental roles regarding compound pharmacies. Hearings are scheduled to determine how to prevent such outbreaks in the future.

The vast majority of patients who developed fungal meningitis after receiving NECC products were being treated for back pain. NECC also makes a heart drug called cardioplegic solution that stops the heart during heart surgery. At least one heart patient developed a fungal infection. So far, none of the NECC ophthalmic products used during eye surgery seem to have resulted in infection.

On October 31 2012, Ameridose LLC, which shares ownership with NECC, voluntarily recalled all its products after an on-site investigation by the Food and Drug Administration. The company did not receive any reports of problems, but decided to pull its products to ensure the medications fully conform with the FDA’s recommendations.

NECC produced more than 2,100 different products and the warning applies only to sterile, injectable drugs. The company also produces topical products, eye drops and other items that are exempt from the warning.

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Does Free Speech Cause Meningitis? The New York Times Thinks So

John K. Ross|Nov. 6, 2012 4:32 pm

New York Timescolumnist Linda Greenhouse isn’t directly saying that the Supreme Court's 2002 decision in Thompson v. Western States Medical Center upholding the commercial speech rights of compounding pharmacies caused the national meningitis outbreak that has killed 30 people to date. She can’t say for sure whether the ruling played any role. Except that’s pretty clearly what she's implying.

First, some background: Compounding pharmacies traditionally mix drugs in small doses for individual patients who need products that are not available commercially. Because of the small scale, clinical trials would be prohibitively expensive and pharmacists—and patients who depend on compounded drugs—benefit from an exemption to premarket review.

Demand for compounded drugs has grown, however, and pharmacists have responded by ramping up their operations to the point where some are more like manufacturers than corner druggists. This prompted a 1997 federal law prohibiting pharmacists from speaking truthfully to doctors about the services they provide.

Here’s Greenhouse:

The idea, as the government later explained to the Supreme Court, was that compounding pharmacies could continue to serve their traditional role of filling doctors’ prescriptions for individual patients, but would be limited in their ability to solicit business on a big scale or to engage in large-scale drug production—in other words, to conduct the kind of multi-state business in which the New England Compounding Pharmacy (sic) was engaged before it was shut down in the wake of the meningitis cases tied to its tainted product.

House lawmakers issue subpoena for director of pharmacy tied to meningitis outbreak

By Associated Press, Updated: Tuesday, November 6, 1:50 PM

WASHINGTON — House lawmakers have issued a subpoena for the director of the pharmacy linked to the deadly meningitis outbreak, after he reportedly declined to appear before Congress next week.

The Energy and Commerce Committee says that Barry Cadden, co-founder of New England Compounding Center, indicated through his lawyer that he would not attend a hearing scheduled for Nov. 14. A message sent to Cadden’s lawyer was not immediately returned.

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Workers at drug factory where meningitis outbreak started banned from working in industry Pharmacists and technicians New England Compounding Center are banned from getting similar jobs at other labs Read more: http://www.ktu.com/cc-common/news/sections/newsarticle.html?feed=104667&article=10552699#ixzz2BTT0Z18L

(UPI) -- Pharmacists and technicians at a U.S. drug-compounding firm linked to a meningitis outbreak can't continue to work in the industry, state regulators said.

The Boston Globe obtained a copy of a letter the Massachusetts Board of Registration in Pharmacy sent to all pharmacists and pharmacy technicians employed by the New England Compounding Center in Framingham, Mass.

The letter stated that an investigation of the outbreak had determined the employees "may present an immediate or serious threat to the public health, safety, and welfare and should immediately cease," the Globe reported Tuesday.

Previously the board voted to seek the permanent surrender of the firm's pharmacy license as well as permanent revocation of the licenses of the company's three primary pharmacists, including co-owner Barry Cadden and his wife Lisa Conigliaro Cadden.

New England Compounding closed early last month and recalled all its products after a steroid produced at the company was linked to 30 deaths and 419 fungal meningitis cases.

Read more: http://www.ktu.com/cc-common/news/sections/newsarticle.html?feed=104667&article=10552699#ixzz2BTTEy31a

Meningitis Wrongful Death Lawsuit Filed By Family of Outbreak Victim

By: Irvin Jackson | Published: November 6th, 2012

An Indiana family has filed a wrongful death lawsuit against the compounding pharmacy linked to a nationwide fungal meningitis outbreak, saying that the illness that claimed the life of Daniel Rohrer after he received an epidural steroid injection that was later recalled. 

The complaint is the latest in a number of lawsuits filed over the fungal meningitis outbreak, which involves more than 400 confirmed infections in 19 states, including 30 deaths.

Rohrer’s family filed the meningitis wrongful death lawsuit last week in Elkhart County Court in Indiana, after that the 68 year old died on October 23. The death was allegedly caused by a tainted injection mixed by the New England Compounding Center (NECC), which has been named as the defendant in the family’s lawsuit.

NECC recalled more than 17,000 vials of methylprednisolone acetate epidural injections, which have been directly linked to the outbreak of fungal meningitis. The CDC estimates that about 14,000 people may have received potentially contaminated injections, and the FDA says it has also found fungus in other drugs distributed by the compounding pharmacy.

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FDA Director Spoke to Senate Re: Compounding Pharmacies Long Before Meningitis Outbreak

Posted by Ellen KlepacNovember 06, 2012 11:44 AM

In the wake of the recent fungal meningitis outbreak, it’s worth taking another look at an October 2003 speech by Steven Galston, then-Acting Director of the Food and Drug Administration’s Center for Drug Evaluation and Evaluation. Galston spoke to the Senate Committee on Health, Education, Labor, and Pensions about the FDA’s responsibility regarding compounding pharmacies.

He noted the importance of compounding pharmacies, a growing business at the time, which could tailor FDA-approved drugs to meet the specific need of a patient by altering the drug or mixing it with another.

He also discussed the rise of compounded drugs that were of “substandard quality” and compounding pharmacies that marketed compounded drugs on a large scale or marketed drugs that were mere copies of FDA-approved drugs.

Galston said some pharmacies may lack the equipment or know-how to properly compound a drug and some of the drugs themselves may not be suitable for mixing or altering in any way, which could lead to potential health risks for patients. Though the majority of compounding pharmacies were “well-trained and well-equipped,” those that were not or chose to improperly market a large number of unapproved drugs could pose a threat to a great number of people. Thanks to NECC’s contaminated epidural steroid, this is a chance we are now all too familiar with.

Because compounding pharmacies could potentially wreak havoc if they went beyond what constitutes traditional compounding, the FDA issued guidelines that outlined the sort of behavior that could get pharmacies in trouble, including:

• Compounding drugs (in unreasonably large amounts) before receiving prescription requests for those drugs;
• Sending large amounts of drugs out of state;
• Mixing ingredients that had not been properly approved;
• Using commercial-scale manufacturing facilities; and
• Making and selling copies of FDA-approved drugs.

Though compounding pharmacies do a lot of good for a lot of patients, this year’s fungal meningitis outbreak shows they are also capable of doing a tremendous amount of harm.

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Previous fungal meningitis outbreak a decade ago resulted in no oversight changes

By David Brown,

Nov 06, 2012 02:09 AM EST

The Washington Post

First, David Brannon couldn’t believe it. Then he couldn’t stand hearing about it.
Hundreds of people were ill with fungal meningitis they had contracted after getting pain-killing injections made by a compounding pharmacy in Massachusetts. Dozens were dead, and the numbers were still rising.
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Press Announcements FDA warns Tennessee company that online product claims violate federal law

Press Announcements FDA warns Tennessee company that online product claims violate federal law

Pennsylvania gets its execution drugs from same type of pharmacy as the one responsible for bacterial meningitis outbreak

By DONALD GILLILAND, The Patriot-News The Patriot-News
on November 05, 2012 at 6:47 PM, updated November 05, 2012 at 7:19 PM

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The drugs Pennsylvania Department of Corrections uses for its lethal injection executions are not standard, FDA-approved medications, but rather made-to-order drugs designed by the same kind of pharmacy - a "compounding pharmacy" - that is currently at the center of a nationwide epidemic of bacterial meningitis among people injected with made-to-order steroids.

Compounding pharmacies mix drugs to order on site and are largely free of the federal quality assurance regulation that applies to standardized drugs, being regulated, instead, by state law.

In addition to producing adulterated products, such compounding pharmacies also have a history of producing drugs that are not of the dosage listed on the label.

That could be significant when it comes to the constitutionality of Pennsylvania's lethal injection protocol because the US Supreme Court has found that if the first drug in the three-drug protocol is not administered properly or at the correct dosage, unconstitutional and excruciating pain could result with the administration of the other two drugs.

A federal class action suit is challenging the constitutionality of Pennsylvania's protocol and has the potential to stay all executions in the state for some time.

Compounded drugs are often cheaper than their FDA-approved equivalent.

The DOC fought hard to keep the source of its drugs out of court, snubbing two federal court orders to divulge the source of the drugs last week, finally complying at the last minute after the threat of sanctions.

The Attorney General's office also attempted on Monday to have federal court proceedings in the case closed to the public. Judge Yvette Kane denied that request, saying there were "issues of greater interest to the public" at stake in the case.

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