PHARMACY

NCPA responds to congressional members’ concerns over short-term cycle dispensing rule

BY Allison Cerra

ALEXANDRIA, Va. — Ten members of Congress expressed concerns over a provision in the Patient Protection and Affordable Care Act that is said to reduce Medicare program costs, according to the Centers for Medicare and Medicaid Services.

In a letter sent to CMS administrator Donald Berwick on Friday, the congressional members — Reps. Peter Roskam, R-Ill.; Aaron Schock, R-Ill.; John Barrow, D-Ga.; Adam Kinzinger, R-Ill.; Lloyd Doggett, D-Texas; Paul Gosar, R-Ariz.; Shelley Capito, R-W.Va.; Geoff Davis, R-Ky.; Sam Graves, R-Mo.; and Nan Hayworth, R-N.Y. — said they were unsure what was motivating CMS’ plan to move ahead with the Notice of Proposed Rulemaking provision, which would limit short-cycle dispensing of brand-name drugs for long-term care facilities. The representatives addressed the lack of evidence that could support the idea that shorter dispensing cycles would save money. In the letter, the representatives urged CMS to delay the implementation.

In response, the National Community Pharmacists Association’s EVP and CEO, Kathleen Jaeger, said she appreciated the representatives speaking up on behalf of pharmacists and patients in long-term care facilities. “While we all share the goal of eliminating waste in programs like Medicare Part D, there is scant evidence substantiating that a move to shorter dispensing cycles would actually reduce costs," Jaeger said. “More importantly, the requirement is very burdensome for pharmacies, which may have to invest significant resources in order to comply with the regulation."

"Before CMS moves forward with implementation, we hope it will conduct a thorough, fact-finding study to determine what is the wisest course of action," Jaeger continued. "Plowing ahead without that data could have unintended consequences, such as higher costs to Medicare or fewer pharmacies providing LTC services. Those are outcomes nobody should want."

The NCPA operates a division that focuses on LTCs, Jaeger pointed out, and said that, “[our] association’s staff and membership will continue working with like-minded organizations to engage Congress, CMS and others on this issue for a positive resolution that benefits patients, payers and pharmacists.”

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PHARMACY

Biodel discloses accelerated development plan for diabetes drugs

BY Allison Cerra

DANBURY, Conn. — A drug maker focused on development and commercialization of diabetes treatments unveiled its accelerating clinical development plans of two drug candidates.

Biodel said BIOD-105 and BIOD-107, known as ultra rapid-acting insulins, are designed to result in more rapid insulin action, compared with currently marketed mealtime insulin analogs.

The company said it is initiating a phase-1 trial in third quarter 2011, which will examine the efficacy of the drugs in Type 1 diabetes patients, and will be followed by a phase-2 trial in fourth quarter 2011 if the initial phase is successful. The phase-2 study is intended to follow the same overall design that would be implemented in phase-3 studies, which would commence in 2012 and include two separate pivotal trials — one in patients with Type 1 diabetes and the other in patients with Type 2 diabetes.

Biodel said it recently received initial guidance from the Food and Drug Administration on the design of two pivotal phase-3 clinical trials. "We have identified two new formulations with commercial target product profiles that appear to be superior to any of our previous ultra rapid-acting human insulin drug candidates," said Errol De Souza, president and CEO of Biodel. "We have accelerated the clinical development program of these formulations and plan to initiate phase-1 clinical testing this month and could initiate phase-3 testing before the end of 2012."

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’60 Minutes’ examines counterfeit drug problem

BY Rob Eder

NEW YORK — "Fake drugs are a big threat and an exploding threat," Kumar Kibble, deputy director of Immigration and Customs Enforcement, told the news program "60 Minutes" in a segment that appeared Sunday night.

Kibble, who tracks counterfeit drugs from their source in clandestine labs around the world to the United States, where they’re typically sold online through rogue pharmacy sites, told "60 Minutes" that increasingly, traditional criminal groups, including many once involved in illegal drug trafficking, are shifting operations to take advantage of the low-risk/high-reward economics of the counterfeit drug trade — a $75 billion-a-year industry, according to estimates.

The segment opened with an early morning raid on a Peruvian counterfeit pill operation run out of an indoor market and a shabby one-room, makeshift lab, where knock-off Pfizer products were being crudely manufactured. Peruvian law enforcement was tipped off about the operation by Pfizer’s John Clark, who heads the company’s global security team, which is comprised of former Federal Bureau of Investigation, Homeland Security and Drug Enforcement Administration agents. The group works with local law enforcement to identify and prosecute international drug counterfeiters.

Timing of the segment was impeccable, as the retail pharmacy industry gathered for the annual National Association of Chain Drug Stores Supply Chain and Logistics Conference this week, March 13 to 15, in San Diego. Shutting down the flow of counterfeit drugs into the United States and preserving the integrity of the nation’s drug supply system has long been a focus of pharmacy industry leaders, and the conference this year featured important educational sessions focused on the topic, as well as demonstrations of new technologies and information system-based solutions aimed at protecting the supply chain.

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