The withdrawal of a multiple sclerosis treatment is likely to lead to even longer product approval times for pharmaceutical companies as pressure mounts on the Food and Drug Administration to improve drug safety, experts say. The news Monday that one patient died and another developed a serious disease while taking the MS treatment Tysabri, made by Biogen Idec Inc. and its Irish partner Elan Corp., is the latest in a series of negative revelations about drugs’ safety and effectiveness. “This is just another black eye for the industry and another black eye for the FDA (news - web sites),” said Jason Napodano, an analyst at Zacks Investment Research Inc. “I think we are in for a dramatic slowdown in the approval process as the FDA wants to see more extensive trials and data.” Tysabri was approved under an accelerated review process reserved for drugs that treat patients with especially serious diseases where a lack of other medicines exists. Napodano said the FDA may also be more selective about which drugs get such special treatment. Experts said the slowdown won’t necessarily come through a mandate from FDA officials demanding more data, but could result from independent reviewers working for the agency.
