While I can’t remember how many of these meetings I have attended over my 40 years, so far this rates with the best of them for a couple of reasons. AAM’s new President and CEO, John A. Murphy III, and we got to meet him for the first time. We profiled John in a previous blog (here) shortly after he accepted the position. John came from the branded side of the house to now energize AAM and represent it with gusto. He shared his vision and noted that the industry has a lot to do to impact the continued viability of the generic industry. The race to the bottom in pricing, PBMs, rebates, Medicare Part B, and the pricing pressure of the current system needs to be challenged. He seems like the man to help do it!
The second reason that I was so happy, was that Janet Woodcock, MD who has worked tirelessly at the FDA for over four decades, was recognized by AAM and presented with the Association’s highest award, the Lifetime Achievement Award. Dr. Woodcock thanked AAM and then did a sit- down with the association’s David Gaugh, Executive Vice President for a lively Q & A session. David asked Dr. Woodcock what was her most favorite and least working things while working at FDA. She noted that she loved the people she worked with and led while she was there, as well as the knowledge and learnings from her interactions with them. Her least favorite thing related to the no matter if you did 1000 things really well, if there was a bad thing that happened, then it was like the entire body of good work was wiped away in the news cycle that occurred. You know you can’t get everything right and if you missed something or if a product was found to have a problem, then you were labeled as terrible. And “a bad headline hurts” and terrible sells a lot more papers than being great at what you do. It also has a very negative impact on morale.
She also spoke about having to walk a narrow line regarding the approval of complex generic products. She noted that you don’t want to have a path so narrow that no one can gain approval, but you also don’t want to be too flexible in your approval requirements, so the products are not equivalent in practice. The science needs to drive the ultimate approval decision. That is why it takes a long time for the FDA to reach a decision on what the right balance of requirements are that need to be placed on complex products such that any approval decision will produce a product that works like the product the generic is copying.
Dr. Woodcock noted that physicians are cautious, and they need to trust the decisions that the FDA makes on both complex generics and biosimilars, and that may take education of the practitioners and time for them to see the product does work the same. The same thing occurred at the passage of Hatch-Waxman 40 years ago, it took healthcare practitioners quite a while to become comfortable with substitution. It worked, and now 90% of all prescriptions are filled generically. Her parting word was to aim high on quality even if financially it may seem difficult. You will then have a better chance of meeting success.
There was one other standout of the day and that was a panel on drug shortages, industry perspective. The panel included David Kendall, Senior Fellow for Health and Fiscal Policy, Third Way, Liz Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Health Distribution Alliance (HAD), Thomas Kraus, Vice President, Government Relations ASHP, Polly Webster JD. MPH., Senior Health Counsel, Senate Committee on Finance and Shana Christrup, Senior Director, Policy AAM. The group all acknowledged that the biggest problem impacting drug shortages was the race to the bottom on generic drug pricing. They discussed the complexity of the problem and acknowledged that one tweak here was going to impact another problem or create a potential unintended consequence somewhere else along the supply chain. The group all agreed that there needs to be a proper incentive for firms to improve the resiliency of the supply chain and that reimbursements and prices for generic drugs needed to rise for positive steps that created stronger quality manufacturing. One person on the panel suggested that perhaps the FDA could stop approving ANDAs for the same molecule once a certain number was approved. That, unfortunately, would not be possible without legislation and you need to remember that there are no provisions that would permit the FDA to refuse-to-receive an ANDA, and today it would be a bigger problem now that generic firms must pay a user fee for each application they submit.
The group also agreed that the problem is multifaceted and because of that, a solution which will be acceptable will be complex. However, the more complex any legislation is the more chance that it may be unmanageable to administer.
It was, indeed, a great Day One and others from Lachman will be providing their thoughts and insight on other sessions that were held on the first day.
