Researchers at Stanford University, the University of Illinois-Chicago and the University of Chicago have proposed 14 widely prescribed medications they say most urgently need additional study to determine how effective and safe they are for off-label uses.

Staff physicians and scientists described by congressional investigators as "a large group" in the FDA's medical device center have complained to commissioner Andrew von Eschenbach that their attempts to use sound science in evaluating medical devices have been thwarted by non-scientific center managers and executives.

The Bush administration's Council of Advisors on Science and Technology said in November that the FDA needs to implement a more transparent, systematic and iterative approach to regulating genomics-based molecular diagnostics.

There is a "rising tide of skepticism" about generic drugs' therapeutic equivalence and CDER efforts to address this has become a top priority, the FDA's director of drug evaluation and research, Janet Woodcock, told a Generic Pharmaceutical Association conference recently.

With the FDA flailing and everyone impressing upon the Obama transition team how important their choice for commissioner will be, few acknowledge how impotent this post has become over the years.

Two consumer-directed pharmacy printouts and a professionally directed labeling piece for Boehringer-Ingelheim's Mirapex were considered misleading, according to a warning letter from FDA's DDMAC.

The American Association for Justice said federal agency documents it obtained through Freedom of Information Act requests show that former FDA chief counsel Daniel Troy was responsible for the Bush administration's efforts to pre-empt state liability claims in many federal agencies.

Ortho-McNeil/Janssen said a Public Citizen petition to the FDA calling for removal of the Ortho Evra contraceptive patch from the market for safety reasons "presents no new information or scientific evidence showing that Ortho Evra is unsafe, ineffective or unnecessary" and should be denied.

The FDA's director of drug evaluation and research, Janet Woodcock, denied in October that an increased focus on drug safety in recent years, fueled by public and congressional criticism of the agency's safety oversight, has made her Center more "conservative."

As the Obama transition team focuses on the nation's highest priorities, don't think for a moment that drug marketing issues will get a pass come Inauguration Day.