Healthy Skepticism Library item: 16521

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Stafford RS, Wagner TH, Lavori PW
New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling
NEJM 2009 Sep 24; 361:(13):1230-3 [Epub ahead of print] August 12, 2009 doi: 10.1056/NEJMp0906490
http://healthcarereform.nejm.org/?p=1421

Abstract:

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 2000.1 The U.S. market for drugs and devices is regulated by the Food and Drug Administration (FDA), which scrutinizes clinical trial data for evidence of safety and efficacy. Although the FDA has been criticized for missteps and inefficiencies in its approval process, these are not the causes of increasing health care expenditures. More relevant is FDA oversight of the labeling and promotion of medical products.

Despite the potential usefulness of labeling information for controlling the unnecessary growth of expenditures, the FDA does not 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. If the FDA label 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…