September 6th 2024
Boruzu is the first ready-to-use version of bortezomib for subcutaneous and intravenous administration in the treatment of multiple myeloma and mantle cell lymphoma.
Inside DDMAC: A Conversation with Thomas Abrams
December 1st 2005Despite heightened scrutiny from industry advocates and the beginnings of self-imposed regulation, pharma companies' violations of DTC regulations have been getting worse, says Tom Abrams, director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). Abrams has been on all sides of drug marketing, from receiving promotions as a pharmacist to creating promotions as a member of industry to regulating promotions as the head of DDMAC. As such, he's in good position to see the big picture.
Are We Aligned Yet? A Medicare Part D Roundtable
November 1st 2005The 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.
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.
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.