WIKIMEDIA COMMONS, TOM VARCO
While many doctors, researchers, and investors believe that the European Medical Agency approves new cancer drugs before the US Food and Drug Administration, that assumption is simply not true, according to a study published last week in Health Affairs. In fact, all 23 new oncology meds approved in Europe and the United States between 2003 and 2010 hit the US market before they become available to European patients, the study revealed. Drugmakers tended to submit their treatments for approval to the FDA before the EMA, and the average review period in the United States took only about 6 months, compared to nearly a year in Europe.
"To patients battling cancer, with no treatment options, access to new medicines five-and-a-half months sooner is a very important and potentially life-saving difference," Ellen Sigal, who chairs and founded the nonprofit advocacy group Friends of Cancer Research, told Reuters...
After recent criticisms that its regulatory practices are too stringent, the FDA can take some solace in the findings, which "reflect FDA's commitment to foster access to effective therapies in a responsive and timely manner," FDA Commissioner Margaret Hamburg said in a statement. Though the agency is "not in a race with other regulatory agencies," added Janet Woodcock, the FDA's top drug official, the study could help dispel the "urban myth" that Europe is leading cancer drug approvals.
Interested in reading more?
Become a Member of
