Accelerated FDA approval and pricey drugs make a rotten combo, doctors argue

Fierce Pharma ------ Should drugs that win FDA approval on an accelerated path—often without strong evidence of efficacy—command the same high prices as products that undergo the full menu of agency scrutiny? Not necessarily, two doctors contend in a new journal article. And they have some ideas for bringing the costs of those drugs way down, at least until their makers can prove they really work.The ideas—which include lower prices until drugs prove themselves out in confirmatory trials—come amid an unprecedented debate over the price tags on drugs in the U.S. Over the past 18 months and more, controversy after controversy have prompted politicians and the public to call for some sort of action to hold down drug costs. Accelerated approval is a problem because it forces Medicare and Medicaid to pay for drugs that can cost hundreds of thousands of dollars and yet may not work for many patients, argue Walid Gellad, associate professor of medicine at the University of Pittsburgh, and Aaron Kesselheim, associate professor of medicine at Brigham & Women’s, in an editorial in the New England Journal of Medicine. To learn more click on the picture below to read the article.