Comparative Effectiveness Between Drugs Nearer

Labeling information on prescription drugs and medical devices should be expanded to include comparative effectiveness, according to a perspective article published in the New England Journal of Medicine.

"New technologies, including prescription drugs and medical devices, are a major driver of increases in U.S. health care expenditures, which have grown by an estimated 71% since 2000," write Randall S. Stafford, MD, PhD, from the Stanford Prevention Research Center at Stanford University in Palo Alto, California, and colleagues. 

The authors explain that despite the potential usefulness of labeling information for controlling the unnecessary growth of expenditures, the US Food and Drug Administration (FDA) does not currently require the inclusion of statements regarding a product's comparative effectiveness. As a result, drug labels may create confusion "as manufacturers strive to insulate their products from price competition through differentiation that is unrelated to health outcomes." 

The authors write that if FDA labels were required to indicate what is and is not known about a product's superiority to other treatments, "then clinicians, patients, and payers would be less willing to pay more for a new treatment without proof that it improved health outcomes. In addition, manufacturers would have an incentive to conduct much-needed active-comparator superiority trials." 

They add, "Drug and device manufacturers [currently] benefit from an unacknowledged information gap that develops as more and more products are tested against placebo, but not each other." This has led to the current regulatory climate, which favors the creation of products that do not differ significantly from existing therapies. 

"As the more recently approved selective serotonin-reuptake inhibitors have shown, me-too drugs can be highly profitable even when older drugs may be better choices," Dr. Stafford and colleagues point out. 

The researchers recommend that in the absence of comparative data, new drug and device labels should include a statement indicating that there is no evidence of the product's superiority to other products. "If payers could readily identify clinically equivalent products, they could treat them as commodities and negotiate on price," the authors write. 

While some may argue that comparative-effectiveness labeling is outside the FDA's expertise -- which has focused primarily on informing the public of drug and device safety issues -- the researchers write that the FDA has considerable expertise in food labeling, which is widely accepted by both manufacturers and consumers. In addition, "Developing more informative [drug and medical device] labels is consistent with the FDA's function as a public health agency." 

N Engl J Med. published online August 12, 2009.