Pharmalot reports on the latest new bill introduced in Congress aimed at speeding the FDA approval process. This one -- called Advancing Breakthrough Therapies for Patients Act --will ask the agency to speed the approval of "breakthrough drugs".
Yet Another Bill To Speed FDA Drug Approvals // Pharmalot.
What's a breakthrough drug? One aimed at a serious or life-threatening illness that has demonstrated preliminary clinical efficacy that suggests a substantial improvment over currently available treatments. The bill would let sponsors apply for breakthrough status and the FDA would need to rule Yea or Nay in 60 days.
The drug sponsor could still also apply for fast-track designations, accelerated approval or priority review status as well. Now we have ABTPA, FAST and TREAT all sitting before various parts of the legislature looking to speed drug approvals in the FDA. And, as PDUFA legislation needs to be renewed (lest the FDA run out of its user fee funding), Congress watchers think that at least parts of any or all of these Bills may have a chance to be added to the new PDUFA reauthorization proceedings.
Charge!
Posted by Bruce Lehr Mar 27th 2012.
A breakthrough drug is usually one that is novel that is either treating a new indication or perhaps using a new mechanism to treat an exisiting indication. A me-too is generally a drug that is very similar to one that is already on the market and offers only (at best) incremental advantages to those pre-existing drugs. It uses the same mechanism and goes after existing indications. Not particularly novel.
Posted by: bigredbruce | 06/08/2012 at 11:14 AM
What's exactly a breakthrough drug? Has it anything to do with me too drugs? I'm looking for it's exactly meaning but I'm not sucessful! I'm a law student and I wanna write about patents and me too drugs. Could you help me?
Posted by: Julia | 06/07/2012 at 07:38 PM