Durata Looks Beyond FDA: Reimbursement Changes May Offer Opening for Long-Acting Anti-infective
This article was originally published in RPM Report
Is the FDA regulatory climate getting better for anti-infective development? One clear “yes” emerges from the approach being taken by Durata Therapeutics in a series of recent investor presentations: Durata is focusing beyond FDA on the next challenge – finding the right commercial opening for long-acting anti-infectives.
You may also be interested in...
Pharma companies are building long-term value propositions that should appeal to Accountable Care Organizations into some go-to-market strategies for new drugs and to repositioning efforts of already marketed drugs that have hit snags. The rationale might seem straightforward—for example, more convenient dosing that improves compliance and cuts down hospitalization rates--but the nuances can be complex. Moreover, even when their products appear to have compelling cases for value, companies have not by and large made ACOs a distinct target for their commercial operations.
With the FDA bottleneck for new anti-infectives showing signs of improvement, the next concern is whether providers will pay high premiums for new anti-infectives and the related challenge of finding the right patients to make high-cost treatments make sense.
In less than two years, FDA has moved from requiring unrealistic approval standards for antibiotics to exploring innovative ways to shorten the pathway for the most-needed drugs. And, surprise: Congress is on board too. After 15 years, there is finally real momentum on antibiotic drug policy. But is it all enough to get companies back in the game?