FDA Reverses Its Decision to Show Anything is Possible with Negotiation
​​[Posted on: Thursday, April 19, 2018]

This week FDA rescinded a previous decision to refuse-to-file (RTF) an NDA from Alkermes for a depression drug without the company addressing any of the deficiencies and additional data requirements listed by FDA at the time of the RTF. The company released a statement claiming that the reversal of the FDA’s decision came about due to “productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission”, which in layman’s terms means the company was able to negotiate with FDA to take a rare action. It is very confusing for the industry when FDA makes such seemingly arbitrary decisions which are at odds with well established practices and precedence. These are events when industry watchers can claim evidence of the black-box phenomena where it is impossible for others to understand the genesis of such decisions by the Agency. Conventionally such RTF issues should have been discussed at the pre-NDA meeting, and if there was some confusion at the FDA that needed “clarifications” by the applicant, why were they not done before issuing an RTF? Does it mean that every time a company has an RTF, it should try to argue against it? Did Alkermes escalate the issue to senior management at FDA or threaten legal action to get this reversal? The reversal happened within 15 days. How was Alkermes able to arrange a meeting with FDA to have such extensive discussions that led to the “unprecedented” action by FDA in such a short notice? Does FDA realize how devastating such arbitrary decisions are for the rest of the industry where practically everyone who ever received a RTF is having second thoughts if they could have a similar outcome? Alkermes is known for successful out-of-the-box legal strategies, so is this an example of a company with strong legal teams to bully the mighty FDA to change its course? The list of additional studies required by FDA in the RTF decision was quite descriptive of all the issues FDA had with the quality of the data. It is hard to imagine that before making such harsh judgment to the initial application, FDA did not at least give the company a chance to clarify the issues. And if FDA was so sloppy, are there other times, they made the same sloppy decision but got away because the company did not challenge the decision. There are many unanswered questions, which we hope will come to light when FDA makes a final decision on this drug and releases the correspondence with the approval package. But one thing should be evident to everyone; challenge every negative decision by FDA to the fullest extent and try to negotiate. You never know what you may uncover that may change the course of your product. Three words would define all strategies going forward – negotiate, negotiate, negotiate.