The FDA should split up. That's the common refrain from a diverse body of observers, and now drug industry representatives are chiming in. Citing the recent nationwide salmonella outbreak, advocates say a split will improve safety on both fronts and create a new drug division that can more efficiently review and quickly approve new drugs.
For a specialty like dermatology that has seen relatively few new drug compounds approved recently, a streamlined review and approval process is attractive. But recommendations to speed the approval process are always tempered by demands that drug reviews become more intensive in order to avoid embarrassing episodes such as the Vioxx debacle and to establish extra layers of protection for patients.
Three worldwide PML infections among patients treated with efalizumab—the European Medicine's Agency called for removal of the drug, while the FDA issued new warnings about the rare brain infection already highlighted in a black box—make safety prominent in dermatologists' minds.
For their part, some patients seem to be adopting more realistic attitudes toward drug development and marketing. Recognizing that some degree of risk is inherent in pharmacologic therapy, they meaningfully discuss treatment decisions with physicians. A team of researchers from Dartmouth Medical School has even proposed to the FDA a new drug labeling system, modeled on the "Nutrition Facts" panel on food. Just as the food label lists a product's fat, calories, fiber, and nutrient content in a standard format, the drug label would provide comparative risk and benefit data that, according to results of a small trial, helps would-be patients make better drug choices.
Sadly, many patients may not read about drug facts or know how to interpret them. Consider that in the 15 years since the Nutrition Panel was mandated, obesity rates have risen dramatically. In 1995, no state in the US reported that 20 percent or more of its citizens had a BMI of 30 or greater. Ten years later the bulk of states reported 20 to 29 percent of individuals at or over a BMI of 30. Three states were in the "30 percent or greater" zone.
Improvements to the initial drug review process and better patient education efforts are necessary and welcome. Physicians and regulators must work together to teach patients how to analyze and assess safety facts. Most sorely needed, though, is a standard process for meaningfully synthesizing and acting on safety data that FDA collects for already-approved drugs. Any dermatologist who has allayed a parent's fears of lymphoma associated with a TCI can attest that agency responses are hardly uniform and frequently difficult to understand. Consistency and transparency would go a long way toward restoring credibility.