Comparative-effectiveness data was available for only about half of new drugs approved by the Food and Drug Administration during the past 10 years. That's according to a new study, published in the May 4 issue of the Journal of the American Medical Association, which examined data about alternative treatment options available at the time of drugs' approval.
Many new drugs lacked comparative-effectiveness data at time of approval
Of 197 drug products approved by the FDA between 2000 and 2010, only 100 had comparative-effectiveness data, researchers found. Whether or not such information was available depended on several factors, including the existence of an alternative treatment and research ethics, the authors wrote.
Additionally, the availability of comparative-effectiveness data varied based on treatment area, with proportions reaching up to nearly 90% for diabetes medications but only 33% for hormones and contraceptives.
“Strategies are needed to enhance the accessibility of, and ultimately the use of, this information, particularly in the early marketing experience, when comparative-effectiveness data from other sources are scarce or nonexistent,” according to the study.
The American Recovery and Reinvestment Act of 2009 allocated $1.1 billion to boost comparative-effectiveness research efforts.
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