Editor's Message

Many industries have found opportunities in the aging of Baby Boomers. Now the consumer electronics industry is targeting older Americans, and neurologists may applaud some of their efforts. According to a recent National Public Radio (NPR) report on the annual Consumer Electronics Show held in Las Vegas last month, enterprising tech developers have introduced memory-challenging video games and other health products. There's even a pill box armed with a remote alarm that can signal far away family members if an elderly patient fails to take a dose of medication.

Of course, the marriage of technology and healthcare is nothing new. If he has his way, President Obama will significantly expand the use of electronic medical records and e-prescribing in efforts to streamline healthcare costs and minimize errors. (Ironically, Mr. Obama will have to abandon his trusty BlackBerry, due to concerns about security.)

Whether for patients or physicians, new technologies represent something that physicians can keep careful tabs on in the coming months—much as they used to anticipate and follow drug approvals. With the total number of approved drugs in 2008 at a paltry 24 (that's actually up from the two years prior) and no indication that the FDA will ramp up the approval process any time soon, keeping an eye on the pipeline has become a decidedly unstimulating pastime.

Observers, supporters, and critics all agree that the FDA has adopted a relatively cautious mien in recent years, in light of Vioxx fallout, the Fen-phen debacle, and other high-profile gaffs. Despite simultaneous calls for a more efficient approval process, as criticism of the agency increases, decision makers will probably be even less inclined to hasten approvals.

No stranger to criticism, the FDA took a particularly hard blow this month when several of its own employees drafted a letter to the incoming Obama administration charging, according to the Associated Press, that the agency is "fundamentally broken." The letter, which claims that high-ranking officials have ordered that certain data be ignored or not fully investigated, specifically emphasizes problems in the device approvals process. The letter suggests a need for restructuring throughout the agency. (See pp. 4-5)

If and how the Obama administration, including Secretary of Health and Human Services designee Tom Daschle, and Congress will be able to overhaul the FDA remains to be seen. If nothing else, it seems the agency must reinvent the approval process so that it is more thorough and transparent in its analysis of data without becoming more laborious and time-consuming. Thoroughness and fairness can coexist with timeliness.