From the Editor: No Substitutes
October 1st 2005In an opinion piece in the September 8 New England Journal of Medicine, Harvard medical professor and long-time industry critic Jerry Avorn takes a whack at FDA, accusing the agency of practicing a level of science that wouldn’t pass muster anywhere else in research-science that’s only "good enough for government work.";
From the Editor: Incorporating Compliance
October 1st 2005Think of the role compliance plays in your job. Now imagine that level of concern increased by 25 percent, 50, or even more. That's what pharma has to look forward to in the next few years, as the effects of old regulatory initiatives, such as 21 CFR Part 11 and Sarbanes Oxley, start fully kicking in-and as we experience the as-yet-unknown regulatory fallout of the new concern with drug safety. It's no surprise that a great portion of this volume of Pharm Exec's Successful Product Manager's Handbook series is given over to compliance.
Thought Leader: Room for Improvement
October 1st 2005When you have a workable technology, the question becomes ‘To what do you apply this technology?’ and ‘Where do you spend your time?’ We really believed we would be most successful by spending a lot of time figuring out which drugs to work on and then working assiduously on those few products with huge potential.
Whose Afraid of Authorized Generics
October 1st 2005No brand manufacturers plan to market generic versions of their own product, at least not until the patent expires. And why would they? As long as the branded version enjoys patent protection, marketing a cut-rate product would eat away profit margin during the years when a drug makes the most money.
Formulary Additions: The Big Picture
October 1st 2005To get along with the CFO, drug companies need to express more data in units that a health plan can integrate into its own internal actuarial analysis. The financial decision makers at a health plan want to know how a new drug affects the value of expected claims on the whole.
Sampling: Crimes in the Closet
October 1st 2005The 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.