Amgen and GSK are competing head-to-head in a new market for a rare blood disorder. The market size is small, but the commercial implications are huge: how will the new regulatory tools imposed by FDA affect competition in the real world?

Signs point to a suppressed market for all aesthetics products for at least the remainder of 2009, but there's some evidence that dermal fillers have escaped the worst effects of the economic downturn. The American Society of Plastic Surgeons reports that while there was a 5% decrease in facelifts in 2008, the use of hyaluronic acid fillers was up by 6%, although dermal filler sales started to take a hit in the final quarter of the year.

Harvey Katzen, MD, has a complaint. As a busy physician running a hematology and oncology practice in suburban Maryland, he's frustrated that two new drugs, both of which were recently approved to combat an unusual blood disorder called chronic ITP, require a lot of extra paperwork before a patient can begin treatment. Welcome to the new reality for pharmaceutical marketing. The paperwork for Amgen's Nplate and GlaxoSmithKline's Promacta is part of a formal Risk Evaluation and Mitigation Strategy, or REMS. The REMS system was created to give FDA greater authority to impose and enforce risk management plans, to address far-ranging concerns about drug safety and the FDA's credibility. Promacta and Nplate are among the first products approved under the new law--and hence provide an early opportunity to see how the new regulatory system plays out in the commercial marketplace.