Tuesday, August 31, 2021

Global -216,900,000/4,500,000; USA – 39,100,000/637,400 Trouble at the FDA. Today it was announced that Marion Gruber and Phil Krause will leave CBER at the FDA. The reason being given is that they are upset that decisions have been made by acip and by the White House that should have been made first at the level of the FDA. This has been superimposed upon the fact that the administration is having a hard time making a decision about who the next FDA commissioner will be. There is pushback from some senators particularly Joe Manchin (D-WV) against Janet Woodcock even though she should be the top candidate. The loss of Marion and Phil is a big blow to the FDA. More drama with the FDA CDC relationship. Another late night call from Larry Horowitz telling me that the CDC with Rochelle want the ACIP to discuss publicly data that might confuse the issue since the FDA has confidential data that might change the direction of the discussion. Somehow or other the CDC does not fully appreciate that traditionally their ACIP working group was allowed to discuss in private data related to a particular study, but they would not publicly discuss it until the FDA weighed in on it. As it currently is rolling out, Rochelle seems somehow influenced perhaps by Amanda Fine who is a CDC employee but who is the executive secretary of the ACIP. They want to publicly discuss data before the FDA weighs in with data that they have that is confidential. Bottom line is that if the ACIP publicly discusses incomplete data, when the FDA weighs in with the confidential data it would cause a lot of confusion. This is driving Jeff crazy and again he is on the verge of firing Rochelle. Again, Jeff is asking me to help solve the problem by speaking to Rochelle and explaining to her why it is so important to do things in the traditional format of giving the FDA the chance to make decisions about data before the ACIP ways in with recommendations concerning those data to the CDC. I called up Peter Marks last night and Peter feels that the CDC and the ACIP are breaking tradition here and Peter feels strongly that it is OK for the working groups acip to discuss data so long as they do not do so publicly before the FDA opines from a regulatory standpoint. PRESS: