Pharmaceutical Executive-12-01-2005

Medicare Part D launches. $23 billion worth of patents expire. FDA wrestles with safety issues. Pharma prepares for unprecedented cost cutting and restructuring. 2006 promises to be banner year-if you like roller coasters.

Some people are infected by HIV strains that are already resistant to FDA-approved drugs because they were transmitted by someone who developed resistance while receiving antiretroviral therapy. As a result, these patients often fail therapy.

Sanofi-Aventis' campaign for Taxotere elicits an emotional response from oncologists.

Dry? Not quite. Instead of 1990s-style blockbusters, pharma's new molecules are niche drugs, cancer treatments and-at last-innovative mechanisms for troublesome targets.

PharmExec's 2005 Pharma Knowledge Quiz

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?

The biggest threat to the success of polio eradication is Nigeria, where the immunization program was suspended on religious grounds in some parts of the country in 2003 and 2004.

Find out how you did on our December 2005 quiz.

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.

In an article for the New York Times, reporter Damien Cave pointed out how few heroes have been publicly recognized by the Administration in the current war. Despite the fact that there have been incredible acts of heroism and gutsy leadership on the ground of this Iraq war, the powers that be, for the most part, are calling no attention to it-at least no prime-time attention. Damien's most damning example came from Major Bruce Norton, a military historian and author of Encyclopedia of American Military Heroes, who recounted how a Marine recently received his Navy Cross, the second-highest military honor-not with ceremony and honor, but in the mail.

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.