INDUSTRY CONCERNED OVER FDA PLAN TO POST UNVALIDATED SAFETY DATA

The pharmaceutical industry is ratcheting up its concerns over the FDA's plan to communicate emerging drug-safety information before it has been fully vetted.

Communication of premature and unvalidated safety observations not only has the potential to confuse healthcare professionals, but it could also unintentionally disrupt beneficial treatment, according to Alan Goldhammer, associate vice president of regulatory affairs at PhRMA.

"Well-founded clinical decisions may be compromised as a patient is moved off of one therapy to a second whose therapeutic risk-benefit profile is less favorable," Goldhammer told a committee of the National Academies' Institute of Medicine (IOM), which has been charged with making recommendations to improve the FDA's oversight system for marketed drugs.

Without describing it by name, Goldhammer was referring to the FDA's proposed Drug Watch website, which the agency plans to use to alert the public about drugs it is actively evaluating for safety problems. The Drug Watch was announced in February as part of an FDA initiative to improve its oversight of drug safety and promote a culture of openness at the agency after a series of high-profile drug-safety concerns.

Consideration must be given to the problems that will arise if this preliminary information turns out not to be valid, Goldhammer said at the IOM meeting. Goldhammer's comments echo recent warnings by Pfizer CEO Hank McKinnell, who noted the website could generate news reports that sensationalize the risks of some medicines. McKinnell said the Drug Watch warnings would be correct in some instances, but many times, once more data is available, they would be wrong.