Regulatory

Dec 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
The public is focused on drug safety, but the real issue isn't approval standards. It's the way drugs expand to unapproved new indications. Are you listening, Acomplia?
Nov 01, 2005
Pharmaceutical Executive
Medicare's Competitive Acquisition Program takes a shot at reforming Part B drug distribution. But the new rules evoke a vast and complicated Rube Goldberg machine, where nobody gains much—except CMS.
Nov 01, 2005
Pharmaceutical Executive
Under one bill, states could license patented drugs to generics companies, paying patent holders a royalty.
Nov 01, 2005
Pharmaceutical Executive
Genentech and Biogen's MabThera has been awaiting NICE appraisal for three years. Merck KGaA's Erbitux has waited two-and-a-half years. A ruling on AstraZeneca's Arimidex isn't expected for more than a year.
Nov 01, 2005
Pharmaceutical Executive
The circumstances of Crawford's departure may complicate the process of securing a permanent FDA leader. Congress and HHS are investigating whether his confirmation process failed to uncover important facts.
Nov 01, 2005
Pharmaceutical Executive
The most salient feature of the Medicare prescription drug benefit is its uncertainties. That was perhaps the key insight at a roundtable conducted by Pharmaceutical Executive in conjunction with the executive summit "Medicare Part D: Can There Be Alignment Between Government Goals and Industry Opportunity?" cosponsored by this magazine and Model N, a revenue management-solution provider. With a panel that included representatives from pharma, the legal community, prescription benefit managers, and data and service providers, the roundtable looked at the goals of Part D, the threats and opportunities it presents to stakeholders, the skills companies need to develop, and the way the playing field is likely to change over the next few years. What follows is an edited version of the conversation.
Oct 01, 2005
Pharmaceutical Executive
The pharmaceutical industry devotes more of its promotional budget to samples than anything else, unless you count the army of sales representatives that delivers them. This year, the average wholesale price of samples passed out to doctors will approach $15 billion—roughly twice the value of samples five years ago. And although few in the industry have come to grips with it, the federal regulations governing this enormous investment have undergone drastic changes.
Oct 01, 2005
Pharmaceutical Executive
The client-agency relationship is a product of its environment. Chock-full of regulatory requirements, scandals, and heightened FDA scrutiny, the current environment leaves much to be desired. But this is hardly news for the pharma industry.
Oct 01, 2005
Pharmaceutical Executive
By Pharmaceutical Executive Editors
UK courts are affirming the belief that medical research and drug development have made a huge contribution to people's quality of life, and that a small but vital part of that work involves the use of animals.
Oct 01, 2005
Pharmaceutical Executive
Product managers would be less disrupted if compliance activities at pharma companies were more anticipatory than reactionary.
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