Parallel universe

An FDA/CMS proposal to conduct parallel reviews for marketing approval and Medicare coverage is being framed by the agencies as a voluntary exercise that expedites payment coverage by starting the Medicare decision-making process while FDA is still conducting its pre-market review.

Although FDA and CMS have stated the so-called parallel review would not change approval standards, both agencies have also said it could change pre-market trial designs, which critics of the idea warn will shift the focus from a safety and efficacy hurdle to demonstrating comparative effectiveness and affordability...