Pharmaceutical Executive-08-01-2005

BMS' use of investigational toxicology puts it in good stead with FDA, which, under its Critical Path initiative, is pushing for more complete toxicology packages.

Integra v. Merck KGaA supports research by large pharmaceutical companies, but it also opens the door to greater use of compounded materials by all parties. Congress may have to clarify its scope.

Imagine drugs that can detect one particular compound in a patient's body and respond to it by releasing a drug. They're not that far away.

Leadership evolves from the dynamic of particular situations. Without Adolf Hitler, Winston Churchill may have been remembered as a quirky backbencher.

SPCs extend a drug's basic patent protection for up to five years, to take into account the time that may have lapsed between the filing of a patent application and the granting of market authorization.

Manufacturers will have to incorporate Part D–specific messaging into all of their current marketing materials. In addition, they should consider publication plans and CME that specifically address the needs of seniors.

As a result of the rapid innovations in drug technology, and the increasing complexities surrounding drugs' safety, cost, and efficacy, the demand for extensive formulary reviews is growing. To keep pace, Pharmacy & Therapeutics (P&T) committees have been ardently reviewing medications to determine which ones deserve inclusion and preferred placements in health plans and formularies. While there are many factors that influence the committees' decisions, with some carrying more weight than others, pharmaceutical execs complain that there is no accurate way to predict which drugs will make the cut.

Elegant positioning strategies often fail when doctors learn that a prescribed product isn't on a patient's managed care formulary.