David's New Book

Tuesday, October 2, 2018

Musings on the Introduction of New Antibacterials to the Marketplace


I know its been a few weeks since my last blog. A great deal of discussion around antibiotic development and pull incentives is still occurring even though the topic has disappeared underneath the continuing stream of news out of Washington. Scott Gottlieb, our FDA Commissioner, recently gave a speech where he emphasized the importance of pull incentives in revitalizing the antibiotic pipeline. The FDA and the Duke Margolis Center just held a conference on the use of real world data and evidence in regulatory considerations. 

Since our webinar a few weeks ago, I keep circling back to the differences between what we need to accomplish for regulatory approval and what is needed to convince clinicians, patients, hospitals, pharmacists, payers and other stakeholders that our new antibiotic is a valuable and important addition to our therapeutic inventory. To be successful, we must address all of these parties above and beyond any regulatory requirements. While I still believe that in spite of all our best efforts, the antibiotics marketplace is still broken, I also think we could be doing a better job addressing the needs and concerns of our most important partners in health care. We clearly need to do better to convince these stakeholders that polymyxins are never the drug of choice when drugs like ceftazidime-avibactam, meropenem-vaborbactam or ceftolozane-tazobactam are also appropriate options. What steps can we take to ease the cost considerations that make our clinical stakeholders hesitant to stock these drugs for the relatively rare cases that they may encounter where these drugs could replace the polymyxins? Should we be going to multiple local depots where such drugs can be stored such that a hospital can obtain a non-formulary item within hours instead of days?  Is that practical? Should we simply not charge for orders but only for use such that hospitals can return unused product? 
 
What more can we do during our pivotal trials or in post-approval studies to convince stakeholders that our new drug should actually be used instead of the older, less efficacious and more toxic options that are readily available? Will sub-population analyses really help?  Will small, unpowered superiority trials help?  Will real world data gathering such as in prospective observations studies help? I can’t help feeling that we are not doing enough talking with the right stakeholders on these and related topics.  

Are we doing enough to convince stakeholders that our new drug, in spite of its cost, is actually cost effective? Have we learned from the approach of the antiviral community in this regard? What are we getting wrong here?

Finally, what can be done to speed the availability of automated susceptibility tests when our drug is launched? Delays of one year and more are unacceptable.  It is not clear that recent FDA guidance will help in this regard (more on this in a future blog). This problem can probably best be resolved at the level of the test manufacturers. 

I know that all companies attempt to explore all of these questions with a number of stakeholders prior to the launch of their new product.  But I also know that either they are not hearing what they are being told or that they are not being told what they need to hear. 

I think that its time once again to gather all stakeholders beyond the regulators together in an objective setting to explore these and other questions on the introduction of new antibacterials to the marketplace.