It will be very interesting to see what transpires on the pending ActiPatch application. My take is that FDA will be very careful to review it's previous work and decision on ALLAY and ensure it does not compound the alleged errors onto ActiPatch as well. This may cause a delay in any ActiPatch ruling while they make sure they get it right.
The other potential outcomes are interesting too. Given that the Inspector General for Health is 'on the ALLAY case', as it were, on one side and BIEL and its legal counsel and Senator Mikulski, a highly accomplished health and women's advocate for a few decades are all on it too,on the other side, who would want to stumble next at FDA?
The Director at FDA would have to shoulder all the responsibility / accountability if the technical error on ALLAY alleged by BIEL is repeated and compounded on her watch. What does she say to the IG then? I could give another 50 'what ifs', but it is an interesting political and tactical situation, in my view.
Heads could roll at one extreme, if BIEL is technically correct and FDA missed the boat a second time on ActiPatch in in its analysis, or, FDA could issue a positive decision on ActiPatch and an immediate ALLAY reversal at the other extreme - sort of,"based upon our subsequent further review of the ActiPatch application and accompanying data following the earlier decision on ALLAY, we have conducted a thorough review and comparison of both the ALLAY and ActiPatch applications and our previous decision relating to ALLAY and find that we have determined that there were minor discrepancies found existent between the two applications which led us to a further clarification process with BioElectronics, the Applicant and the implementation of a corrective procedure to the previous ALLAY decision, etc., etc."
That would be very cool face-saving for the FDA, which may be what is needed. And there are lots of diplomatic possibilities in between. In any event, if such were to occur, that would be the time the company simply says "thank you" and moves on, thereby allowing the necessary face-saving. No question in my mind, this could be a diplomacy play.
If anyone believes for one second that FDA has not already looked carefully into the allegations that they screwed up and determined that an error was or was not made by FDA, then they are naive. If an error was indeed made as alleged by BIEL, then some folks at FDA have already huddled and asked questions such as, "what are we going to say?" or, "how can we correct this?". I hope this is the case, rather than stubbornly digging their heels in to defend to the death a wrongful decision. FDA has made erros before and probably knows how to correct them. I just hope BIEL's protests are well founded in the technicals and science of it all, which I know nothing about.
