Study: FDA is Faster than Europe, Canada in Drug Approvals

, former deputy director, Center for Science & Democracy | May 18, 2012, 11:49 am EDT
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In the New England Journal of Medicine this week, scientists from Yale University published research finding that the Food and Drug Administration approves drugs faster than its counterparts in Canada and Europe. (Media coverage is here and here.) The study reinforces the fact that FDA can approve drugs with relative speed while putting the safety of Americans first.

Photo:, higlu

The authors argue that review speed should not be the focus of the Prescription Drug User Fee Act (PDUFA V) legislation Congress is currently debating. The legislation will set the rules for how the FDA approves drugs over the next five years. They write:

“Our analysis of novel therepeutics approved between 2001 and 2010 shows that the FDA has provided more rapid reviews of applications involving novel therepeutics than have the EMA and Health Canada and that the vast majority of the novel therepeutics first received approval for use in the United States…these findings contradict recent criticisms of the speed of review by the FDA and question whether review speed is justified as an emphasis for PDUFA V, particularly since the FDA continues to outpace its European and Canadian Peers.”

Patient safety should be the priority, which can only be achieved through an FDA that is sufficiently independent and able make drug approval decisions based on the best available science. This means retaining standards that reduce and disclose conflicts of interest for those who serve on federal advisory committees. It also means maintaining transparency in approval decisions so that inappropriate commercial influence on the process can be discouraged and weeded out.

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  • Dale M. Heckman, PhD.

    Last week my urologist prescribed a new pharmaceutical for me in preparation for our next appointment. At home, reading the fine print that came with this new drug, I saw the caveats and advice about possible “side effects” stood out boldly and alarmingly. “And these are not all the possible side effects. If you experience other side effects, report them immediately to your doctor.” DUH! Is this unusual splitting headache a side effect from X ? Or from one of the other 5 drugs? And my new onset of Y –Is that from this drug or some other, or simply natural?
    Such fine-print statements from the manufacturer clearly intend only to protect the maker legally against future lawsuits; they protect the maker, not the user. HOW CAN MY F.D.A. pass along this drug for my use with SO MANY UNKNOWNS and UNTESTEDS? O.K., you know how to CYA legally. Now where does that leave me, a consumer / patient? In this particular case, I simply threw the drug away. I’ll not be their sucker!