News Briefs: Study: Two-thirds of new drugs lack novel action
Two-thirds of the prescription drugs approved by the Food and Drug Administration (FDA) between 1989 and 2000 were modified versions of existing medicines or identical to drugs already on the market. About one-third were drugs based on new molecules that often treat diseases in novel ways, a new study claims. And only 15% of drugs approved during the period both used new chemical compounds as their active ingredients and were deemed by the FDA to provide significant improvement over existing medicines.
The study, by the nonprofit National Institute for Health Care Management (NIHCM) Foundation in Washington, DC, also found that the bulk of the increase in spending on new prescription drugs between 1995 and 2000 was on medicines the FDA did not designate as priority for review. The FDA approved 1,035 drugs during the period 1989-2000; 361 (35%) were new molecular entities, the study says. The remaining 674 drugs (65%) contained active ingredients that were already available in previously approved drugs.
Twenty-four percent (244) of the 1,035 drugs the FDA approved between 1989 and 2000 were categorized as priority drugs with promise of significantly improved efficacy and/or safety. Seventy-six percent (791) were categorized as standard drugs.
The Pharmaceutical Research and Manufacturers of America (PhRMA) in Washington, DC, spoke out strongly against the study’s conclusions, calling the NIHCM a "tool of the Blue Cross and Blue Shield companies." "From what we have been told, today’s NIHCM report appears to be little more than a political and financially motivated cheap shot masquerading as science in the public interest," says Richard Smith, PhRMA’s vice president of policy and research. This report, he says, "conveniently ignores many of the basic facts about drug research — not the least of which is that innovation rests in the lives of its beholders."
For more information about the report, visit the web site: www.nihcm.org/innovations.pdf.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content