Hello E-Sisters. So we finally got to sit down and hash out our notes from the FDA meeting. Here is a brief summary of the topics discussed and the FDA responses. We are sending out a follow up email with more questions, comments, and concerns and are working on that today.
FDA meeting with members of Essure Problems
Mary (Peper) Long
The meeting was opened by Peper Long who started out by saying that what the FDA was allowed to discuss was limited to publicly available and publicly disclosed information. They then opened up the floor to us.
Holly Ennis was the first to speak. She started out with some questions regarding the Black Box warning. (BBW) She asked what is the time frame for implementing the warning, and who is responsible for creating the actual verbiage for the warning. When does the FDA anticipate the BBW being initiated and required to be on the packaging. She also asked where the BBW was going to be placed. Would it be limited to the actual product packaging that only the physician would see, or would it be included in the pamphlets/brochures, advertising, and on the manufacturer's website. Final question was, is the verbiage going to be mandated, or required, or is it just going to be a suggestion. She then also asked what was going to be included in the patient decision checklist, and similarly would it be universal and mandated or would it be only a suggestion by the FDA to the manufacturer. Also, how can the FDA ensure or implement that these checklists are even given to the patients by the physician? Also, they should be given at the time of the initial patient consultation not 5 minutes before undergoing the procedure. (particularly after being sedated.)
Peper was the first to reply. She decided to start with the definition of an FDA “final guidance”. Final guidance is a recommendation to the manufacturer. They aren't “regulations” and manufacturers aren't required to follow them. However, they “do carry weight.” If the FDA wanted them to be mandated they would need to go through regulations, formal rule making, and that can take years. They are currently not pursuing regulations for essure. So within this particular guidance will be the suggestion/recommendation for the BBW, and the patient decision checklist. Once the guidance is final, Bayer will have to submit a supplement to the PMA for a labeling change, and it will have to be approved by Benjamin Fisher and his staff. If the staff is happy with it, they will approve it, if they are not happy with it, it does not get approved. When asked if legally Bayer had to supply the BBW, Ben said “I don't know”. When asked when the guidance on Essure (which we found out is not specific to essure but applies to all hysteroscopically delivered sterilizations devices) will be available, the answer was “as soon as possible”. We were informed that over 1300 comments came in on the docket, and still needed to be reviewed by the FDA before they finalize the guidance document. All they could say was that it was a priority and they are working on it and it will be done as soon as possible. Then we asked how long will Bayer have to implement the new labeling changes once the guidance is finalized. There is not mandated time frame.
When asked if there was a time frame for Bayer to submit its PMA supplement once the guidance is finalized, we were told that it is open. Again, no time frame. Angie asked why is the guidance not going to be specific to essure, but why is it going to be including all hysteroscopic sterilization devices when essure is the only one on the market? Ben answered that because going forward, when another device comes to market, the FDA does not want to have to create yet another guidance document.
We next discussed the recent report issued by the FDA discussing the allegations of misconduct and changes of records during the clinical trials. We questioned why did the CRF reviews only look at four endpoints and why were the birthdate changes not looked at? Ron said it was not on their list of things to look at when they took this on. Who did the CRF review? Ron and his team consisting of about a dozen people. 745 patients records were there. These records included both original documents and digital records.
Madris then brought up some data on pregnancies and other issues she's finding in the public data. (We wish not to disclose those communications publicly, but will say that the FDA was a little shaken by her findings.)
Next area of concern we discussed was the upcoming clinical trials. When asked if the manufacturer was going to use the current 305 model in the post market clinical studies that they have been ordered to begin. Ron said that the FDA was not allowed to disclose that information. We asked when does it become public, how much of it becomes public, what are the parameters of the trial…. FDA answered that what’s up on the website is what's available to the public. It's FOIable, but will be redacted.
What criteria will they use for the screening, if they exclude people that have known nickel allergies then obviously they are not going to get the reactions to nickel that others are experiencing. Ben Fisher asked “So are you suggesting that this be implanted in someone with a known nickel allergy?” Holly responded obviously not, but then the data will be skewed and the true numbers of adverse reactions to the device will be altered if persons with known contraindications to the device (metal allergies, autoimmune issues,etc) are excluded.
We then discussed the parameters of a retrospective study looking at existing data, and how we think that would be a much quicker and more effective way of collecting real world data already available on essure. They seemed to agree, however it was not something the FDA could fund or take on. But they assured us they were doing everything they could as quickly as they could. They also wanted to reassure us that even though the guidance is only a recommendation, that the manufacturer would take it very seriously and it would be taking effect in a timely manner. Then at precisely 60 minutes, our meeting was terminated as our time was up.