Labels Should Tell You How Drug Compares With Similar Treatments Say Researchers

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Main Category: Regulatory Affairs / Drug Approvals
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Article Date: 19 Aug 2009 - 0:00 PDT

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Researchers from a leading US medical institution want the US Food and Drug Administration (FDA) to require drug companies to describe on the label how the new product compares with existing ones and suggest that in many cases they would reveal the new one was no better and this would make patients and insurers less likely to pay for newer treatments.

Lead author Dr Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center at Stanford University School of Medicine in Palo Alto, California, and colleagues wrote an essay in the 12 August issue in the New England Journal of Medicine, NEJM that says current drug labelling only tells you what is is already known about the drug and it's about time it also told you about the unknowns.

They also wrote that if the FDA were to require drug companies and device manufacturers to show how a new treatment or device compares with current ones, it would spur them to design more informative clinical trials that tested the new product against exisiting therapies and not just against placebo.

Their paper opens with the observation that:

"New technologies, including prescription drugs and medical devices, are a major driver of increases in US health care expenditures, which have grown by an estimated 71 per cent since 2000."

The authors argue that although the FDA has "been criticized for missteps and inefficiencies in its approval process", it is not this that has driven up health care expenditure.

"More relevant is FDA oversight of the labeling and promotion of medical products," they added.

Stafford said in a separate statement that:

"Drug and device manufacturers benefit from an unacknowledged information gap that develops as more and more products are tested against placebo, but not each other."

At the moment, the FDA does not require drug companies to include statements about how their new product compares with existing treatments. All they required to do is show that it performs better than placebo, without harmful side effects.

Stafford said the problem with this approach is that:

"The public, including physicians, often view FDA approval as constituting more than it does."

"There's an inherent tendency for physicians and patients to want the newest thing and to assume that newer and more expensive means better, although this is often not the case," he added.

That would not be so bad if the new products were the same price as the ones already on the market, wrote the authors, but the new therapy is almost always more expensive, particularly when the existing drugs are also available in generic form.

They suggest that appetite for the newest drug might be curbed if patients could see evidence that newer does not necessarily mean better.

Stafford and colleagues want the FDA to require labels to show statements like:

"Although this drug has been shown to lower blood pressure more effectively than placebo, it has not been shown to be more effective than other members of the same drug class."

Some might argue that requiring the the FDA to do this takes the federal agency away from its main job of informing the public about the safety of drugs and medical products, but Stafford and colleagues believe that insisting on such labels is consistent with the FDA's re-invigorated role as a public health agency.

Stafford's co-authors are Dr Philip Lavori, professor of health research and policy, and Dr Todd Wagner, health economist at the Veterans Affairs Palo Alto Health Care System and consulting assistant professor of health research and policy at the medical school.

"New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling."
Randall S. Stafford, Todd H. Wagner, and Philip W. Lavori.
New England Journal of Medicine, Published online 12 August 2009.
DOI: 10.1056/NEJMp0906490

Source: Stanford School of Medicine.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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