Illnesses Fuel Scrutiny of Pharmacies

By JONATHAN D. ROCKOFF and TIMOTHY W. MARTIN

A meningitis outbreak that has now killed five patients and sickened 35 is focusing renewed attention on the little-regulated world of drug-mixing pharmacies, after injections made by a Massachusetts facility were tied to the illnesses.

The New England Compounding Center surrendered its state license to operate on Wednesday, the state health department said. Officials urged doctors and hospitals to avoid the pharmacy, which prepared steroid injections for lower back pain that are being investigated for possible contamination.

Officials at the pharmacy couldn't be reached for comment.

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Board probed pharmacy tied to meningitis

Board probed pharmacy tied to meningitis

Is it a Question of Oversight?

In a Drug Linked to a Deadly Meningitis Outbreak, a Question of Oversight

The growing outbreak of meningitis was a calamity waiting to happen — the result of a lightly regulated type of drug production that had a troubled past colliding with a popular treatment.http://www.nytimes.com/2012/10/05/health/news-analysis-a-question-of-oversight-on-compounding-pharmacies.html?smid=pl-share

List of 23 States that Received Compounded Injection from New England Compounding Center

Twenty-three states have received medication from NECC among the three recalled lots: California, Connecticut,  Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas and West Virginia.

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The International Academy of Compounding Pharmacists Responds to Meningitis Outbreak Tied to Compounding Pharmacy

The International Academy of Compounding Pharmacists Responds to Meningitis Outbreak Tied to Compounding Pharmacy

FDA: Avoid drugs from company tied to meningitis

MIKE STOBBE, AP Medical Writer

Updated 1:38 p.m., Thursday, October 4, 2012EW YORK (AP) — U.S. health officials ramped up warnings Thursday about a Massachusetts specialty pharmacy linked to a widening outbreak of a rare kind of meningitis, urging doctors and hospitals not to use any products from the company.

Investigators this week found contamination in a sealed vial of the steroid at the New England Compounding Center in Framingham, Mass., according to Food and Drug Administration officials.

Tests are under way to determine if it is the same fungus blamed in the outbreak that has sickened 35 people in six states. Five of them have died. All received steroid shots for back pain.

"Out of an abundance of caution, we advise all health care practitioners not to use any product" from the company, said Ilisa Bernstein, director of compliance for the FDA's Center for Drug Evaluation and Research.

The company recalled the steroid medication last week and has shut down operations. The recalled steroid had been shipped to facilities in 23 states since July.

The type of fungal meningitis involved is not contagious like the more common forms. 

Read more: http://www.sfgate.com/news/article/FDA-Avoid-drugs-from-company-tied-to-meningitis-3916606.php#ixzz28Mt2uvJ6

Regulators scrutinize arcane realm of pet drug sales

October 3, 2012
By: Jennifer Fiala
For The VIN News Service 
The markup on pet medications sold in Dr. Link Welborn’s Tampa-area veterinary practices is half of what it was three years ago due to price cuts compelled by competition for drug sales.

Still, Welborn writes prescriptions daily in hopes that owners who save money on medications might spend more on needed medical care. He’d rather run blood work to help identify the cause of a patient’s illness than merely sell an antibiotic to treat some mystery infection.

“Virtually every veterinary visit includes two conversations: one about care and one about costs,” Welborn said Tuesday at Federal Trade Commission (FTC) offices in Washington, D.C. “Veterinarians help pet-owning consumers spend their money wisely every day.”

Welborn’s insight culminated eight hours of panel talks to explore whether government action is needed to ensure that consumers can price shop for pet medications. Traditionally, veterinarians both prescribe and sell drugs — a system that some consider a conflict of interest. With online pharmacies and retailers seeking a slice of the pet medications market, competitors want to require veterinarians to provide prescriptions automatically to pet owners, whether requested or not. 
In response, FTC officials are eyeing the pet product distribution landscape, anticipating that the passage of a bill in Congress will require the agency to promulgate rules related to veterinary prescriptions.

The Fairness to Pet Owners Act of 2011, or HR 1406, is buried in a House subcommittee where it’s unlikely to emerge for a vote this year. Nevertheless, the FTC is paying attention. Charged with protecting consumers, agency officials called for Tuesday’s workshop to determine how pet owners are impacted by a convoluted distribution system characterized by exclusionary sales policies and clandestine transactions. 
Drug company officials, antitrust lawyers, online pharmacy representatives, leaders with the American Veterinary Medical Association (AVMA) and a former Wal-Mart insider are among those who gathered to debate the issues. While some accused veterinarians of engaging in anticompetitive behavior by discouraging clients from shopping outside their practices, many pointed the finger at manufacturers that have policies to limit product sales to practicing veterinarians. 
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Press Announcements FDA takes action against thousands of illegal Internet pharmacies

Press Announcements FDA takes action against thousands of illegal Internet pharmacies

Outbreak spotlights risks from custom-mixed drugs

Outbreak spotlights risks from custom-mixed drugs

FDA cracks down on thousands of websites for selling bad drugs

(Reuters) - The U.S. Food and Drug Administration on Thursday said it has cracked down on thousands of online pharmacies for selling potentially unsafe, unapproved or fake pharmaceuticals, including the erectile dysfunction drug Viagra and antiviral Tamiflu.

The FDA, working with international regulatory and law enforcement agencies from about 100 countries, said it took action against more than 4,100 Internet pharmacies, bring civil and criminal charges, removing offending websites and seizing drugs worldwide.

The move was part of the fifth annual International Internet Week of Action, a global effort to fight the online sale and distribution of potentially counterfeit and illegal medicine.

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