Pharmaceutical Executive-01-01-2006

Pharmaceutical Executive

Legal: Shifting Perspective on Off-Label Promotion

January 01, 2006

Legal

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The omission of criminal charges for off-label promotion of Serostim is surprising, because the government's earlier plea with Pfizer sent a strong signal that it would criminally charge companies engaged in off-label marketing.

Leadership: 100 Days of Scrutiny

January 01, 2006

Leadership

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Leaders who are new on the job should get out of their nice offices and go sit with their direct reports. Sit with them in their spaces, over lunch or coffee-anyplace but your space. You want them to be completely comfortable.

Opinion: Memo to von Eschenbach

January 01, 2006

Opinion

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Often, post-approval marketing studies don't materialize because drug companies question their value. Independent review of the need for such studies would address pharma's concern that they may be warranted.

What Ever Happened to Critical Path

January 01, 2006

Features

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To Janet Woodcock, Critical Path hasn't been dying, it's been getting work done."People shouldn't underestimate the difficulties of creating new models. A lot of things worth doing can't happen quickly."

Washington Report: PDUFA Blues

January 01, 2006

Washington Report

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FDA wants flexibility to use user-fee revenues to extend drug safety oversight, to review direct-to-consumer advertising before it goes public, and to modernize the ever longer and more complex drug development process.

Thought Leader: Q&A with Cheryl Buxton

January 01, 2006

Thought Leader

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There was a time when Merck was looked upon as the granddaddy of all pharma companies. As the self-proclaimed oldest pharmaceutical and chemical company in the world, people wanted to work at Merck for its sterling reputation, excellent products, and job security.

Global Report: The UK's New Code of Conduct

January 01, 2006

Global Report

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Serious offenders of the new Association of the British Pharmaceutical Industry's Code of Practice can be "named and shamed" with adverts in the trade press. Details of breaches by companies will be posted online.

Patient Assistant Programs and Medicare Part D

January 01, 2006

Features

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Patient-Program Interface Nearly one-third (2.5 million) of the estimated eight million Americans currently enrolled in PAPs are over age 65 and will be eligible to participate in the government's Part D program.

A Fresh Look at Co-morbidity

January 01, 2006

Features

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As americans age, they are likely to suffer from more than one chronic condition at a time. So as the country's population grays, the rate at which patients presenting co-morbid indications will increase, as will the absolute number of patients whose treatment must be adjusted for more than one disease. These are not surprising facts, but they deserve careful consideration by pharma manufacturers and marketers.