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FDA to improve drug security with new system

The FDA is developing standards for a system that will help identify and trace certain prescription drugs as they’re distributed within the U.S.


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“The ultimate goal is to identify each individual prescription drug package in a way that will enable rapid and accurate verification of the legitimacy of the product, which will be an important tool in the fight against counterfeit drugs,” explained Ilisa Bernstein, deputy director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in a blog post.

The system will be interoperable, giving different stakeholders in the drug supply chain the ability to communicate and share information about a drug and its location, according to Bernstein.

Under the Drug Supply Chain Security Act, the FDA must issue draft guidance by Nov. 27, 2014, and many stakeholders must establish systems for compliance by Jan. 1, 2015.

The FDA has opened a docket in the Federal Register with questions for stakeholders about the systems they use to exchange information related to prescription drug transactions. The docket is open until April 21.

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FDA Warns NY Rancher About Potentially Harmful Drug Residues

The U.S. Food and Drug Administration has issued a warning letter to the owner of Riverview Ranch and Livestock in New York, after an investigation found that the operation sold an adulterated animal for slaughter for food.

The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) analyzed kidney tissue samples of a bob veal calf the ranch sold in April and found the presence of tulathromycin. FDA has not established a tolerance for residues of the antibiotic in the kidney tissue in preruminating calves.

The letter states that Riverview did not use the tulathromycin as directed by its approved labeling or by a veterinarian, resulting in the illegal drug residue.

In addition, the ranch failed to maintain treatment records of medicated animals that could keep potentially harmful drug residues from entering the food supply.

FDA directed the ranch to “take prompt action to correct the violations” and “establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.”

Food Safety News

Drug Stores Lead September Gains

NEW YORK — Sales at the nation’s drug stores rose 6% in September, leading all retail channels, according to a report Thursday from the International Council of Shopping Centers.

Overall, U.S. chain-store sales posted gains of 4% for the month, compared to year-ago results. Excluding gas, sales were actually up 5.1%.


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“The biggest story line here is that the September performance was led by the drug-store segment, posting its strongest monthly showing since April 2007,” said Michael P. Niemira, vice president of research and chief economist for ICSC. “This seemingly heralds the full recovery of this segment after an extended period of weakness due to several mitigating factors.”

In April 2007 the drug-store segment had a 6.7% sales gain. Apparel was the weakest performing segment in September, posting a 0.1% gain.

For October, ICSC research projects that comparable-store sales will increase between 3% and 4% — although the group cautioned that the federal government shutdown does have the potential to curb spending during the month, “biasing the October expectations to a slightly weaker performance even on the heels of a strong gain in September.”

The ICSC data combines comparable- or same-store sales and total store sales for publicly traded retailers to calculate an index.

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Drug Stores Lead September Gains

NEW YORK — Sales at the nation’s drug stores rose 6% in September, leading all retail channels, according to a report Thursday from the International Council of Shopping Centers.

Overall, U.S. chain-store sales posted gains of 4% for the month, compared to year-ago results. Excluding gas, sales were actually up 5.1%.


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Follow @SN_News for updates throughout the day.


“The biggest story line here is that the September performance was led by the drug-store segment, posting its strongest monthly showing since April 2007,” said Michael P. Niemira, vice president of research and chief economist for ICSC. “This seemingly heralds the full recovery of this segment after an extended period of weakness due to several mitigating factors.”

In April 2007 the drug-store segment had a 6.7% sales gain. Apparel was the weakest performing segment in September, posting a 0.1% gain.

For October, ICSC research projects that comparable-store sales will increase between 3% and 4% — although the group cautioned that the federal government shutdown does have the potential to curb spending during the month, “biasing the October expectations to a slightly weaker performance even on the heels of a strong gain in September.”

The ICSC data combines comparable- or same-store sales and total store sales for publicly traded retailers to calculate an index.

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Ahold Sues Drug Companies

QUINCY, Mass. — Ahold USA has filed suit against the makers of the drug Solodyn, citing “substantial losses” resulting from the drug maker’s attempts to keep the top-selling acne treatment from being available in cheaper generic form.

In a suit filed this week in U.S. District Court in Boston, Ahold alleged that Medicis, the maker of Solodyn, engaged in several illegal tactics to extend its monopoly on its patent for the drug, including paying generic manufacturers to delay introductions. Generic drug manufacturers Impax, Lupin and Teva Pharmaceuticals are named as co-defendants in the suit.

Ahold filed the suit on behalf of itself and a class of plaintiffs that would include any purchaser of Solodyn since Feb. 3, 2009. Plaintiffs, the suit said, “paid artificially inflated prices for minocycline hydrochloride extended release tablets and were deprived of the benefits of earlier and more robust competition from cheaper generic versions.”


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Ahold, which operates Stop & Shop and Giant chains in the U.S., did not specify the amount of damages it was seeking.

Medicis, a division of Valeant Pharmaceuticals, has not yet responded to the compliant.

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Loblaw to Buy Shoppers Drug Chain

TORONTO — Loblaw Cos. here on Monday said it has agreed to acquire Shoppers Drug Mart, Canada’s largest drug store chain, for about $ 11.9 billion (U.S.).

“This transformational partnership changes the retail landscape in Canada. With scale and capability, we will be able to accelerate our momentum and strengthen our position in the increasingly competitive marketplace,” said Galen G. Weston, executive chairman of Loblaw. “This combination creates a compelling new blueprint for the future, positioning us to capitalize on important trends in society, from the emphasis on health, wellness and nutrition, to the imperatives of value and convenience.”


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Loblaw said it would retain the Shoppers name and operate it as a separate division of Loblaw. Shoppers operates 1,242 Shoppers Drug Mart and Pharmaprix stores across Canada, and also also licenses or owns 57 medical clinic pharmacies operating under the name Shoppers Simply Pharmacy (Pharmaprix Simplement Santé in Québec) and six luxury beauty stores operating as Murale. Shoppers also owns and operates 62 Shoppers Home Health Care stores.

Loblaw said the acquisition gives it a “powerful footprint in the important and growing small-urban store sector.” It also said it would expand Shoppers’ offerings to include Loblaw’s private label and convenience food.

“We are delighted to partner with Loblaw to leverage our combined strengths,” said Domenic Pilla, president and chief executive officer of Shoppers Drug Mart. “For our shareholders, this transaction provides significant and immediate value, as well as the ability to benefit from future upside by virtue of their continued ownership of shares in the combined company.”

Loblaw said it would pay $ 33.18 (Canadian) in cash plus 0.5965 Loblaw common shares for each share of Shoppers.

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Survey shows increase in resistance to drug therapies among bovine respiratory disease cases

June 28, 2013 — A survey of records of bovine respiratory disease cases at the Kansas State Veterinary Diagnostic Laboratory showed that drug resistance in one of the primary pathogens that cause BRD, Mannheimia haemolytica, increased over a three-year period.

“We have been seeing an increase in the number of antibiotic resistant bacteria that cause pneumonia (also called BRD) in cattle,” said Brian Lubbers, assistant professor in the diagnostic lab, based at Kansas State University. “Many of these bacteria are resistant to, not one, but almost all of the antibiotics that we use to treat pneumonia in cattle.”

BRD is one of the most important diseases of feedlot cattle, particularly, said Lubbers, adding that the economic toll from the disease has been estimated to approach $ 1 billion annually in the United States alone, if one takes into account drug and labor costs, decreased production, and animal death losses.

Until now, one of the aspects that has not been studied very well is the cost linked to antimicrobial resistance in BRD cases, he said. To take a closer look, he and colleague Gregg Hanzlicek, also an assistant professor in the diagnostic lab, examined records of cases in which specimens of bovine lung tissue were submitted to the diagnostic lab over the three years, 2009 to 2011. Most of the cattle were from Kansas and Nebraska.

They found that over that period, a high percentage of M. haemolytica bacteria recovered from cattle lungs were resistant to several of the drugs typically used to treat that pathogen. The researchers also found, however, that no specimens were resistant to all six antimicrobial drugs.

The study was funded internally by the diagnostic lab.

Using resistance to three or more antimicrobials as the definition of multi-drug resistance, 63 percent of the bacteria would be classified as multidrug resistant in 2011, compared with 46 percent in 2010 and 42 percent in 2009.

The results of the study were published by the Journal of Veterinary Diagnostic Investigation.

“Antimicrobial resistance in veterinary medicine has received a considerable amount of recognition as a potential factor leading to antimicrobial resistance in human medicine,” Lubbers said. “However, the contribution of multidrug resistance to limited or failed therapy in veterinary patients has received much less attention.”

Because there are a limited number of antimicrobial drugs that can be used for treatment of BRD pathogens, Lubbers said, multidrug resistance in those pathogens poses a severe threat to the livestock industry.

“We (KSVDL) consider this type of information to be part of our active ongoing disease surveillance and will continue this work,” Lubbers said. “The questions of how these bacteria develop or where they come from, how widespread they are, and what is the impact on cattle production are still unanswered. We are actively seeking industry partners to investigate these questions.”

ScienceDaily: Agriculture and Food News

Club, Dollar, Drug Channels Pace Retail Growth: Kantar

NEW YORK — Drug stores, dollar stores and membership warehouse clubs will be the fastest-growing retail formats during the next five years, according to a presentation by Kantar Retail here Wednesday.

Those three formats are expected to outpace Kantar’s projected 4.5% pace of overall retail sales growth by 2018. Supermarkets are projected to grow their sales by about 4.4% in the next five years, Kantar projected.

“One reason club stores and dollar stores will be successful is that they both do a good job curating product,” said Bryan Gildenberg, chief knowledge officer, Kantar Retail.

Drug stores, meanwhile, are in a “sweet spot” because of $ 15 billion in projected increases in spending on prescription drugs in 2014 through health care reform. That channel is expected to grow about 4.8% in the next five years.


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Health care reform is also expected to boost business at in-store climics, he said, noting that 30 million more people will be insured started next year, with no real increase in the number of doctors to treat them.

“In-store clinics will become a much bigger deal,” he said.

Brick-and-mortar retail sales overall — excluding online sales — are expected to grow at a 3.5% pace, Gildenberg said.

Kantar projected that retail square footage would grow about 1.5% in the next five years, with 60% of that coming from small-format stores like drug stores, dollar stores and convenience stores.

Online food sales are projected to increase from 1% of total food sales currently to about 5% of food sales by 2020.

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