Regulatory

Sep 01, 2006
Pharmaceutical Executive
Public revulsion at animal-rights extremists is damaging their cause. The majority of people deem the worst offenders to be terrorists.
Sep 01, 2006
Pharmaceutical Executive
The world according to New Hampshire: Doctors prescribe expensive drugs because pharma reps sell them. Interfere with the selling, and you'll cut down on the prescribing. It's a plan. But for what?
Dec 01, 2005
Pharmaceutical Executive
Despite 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.
Dec 01, 2005
Pharmaceutical Executive
FDA may be receiving fewer new drug applications for truly innovative products, but it has been overwhelmed this year with 800 abbreviated NDAs for generic drugs and thousands of supplements.
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.
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