That title is the only way that I can describe the events of the last few days. Like so many other things this year, what we’re seeing now at the top of the drug regulatory structure is unprecedented, and not in a good way at all. Let’s recap.
A few days ago, HHS Secretary Alex Azar sent out what has to be considered a very unusual memo. Its key point (as written) is:
The authority to sign and issue any rule for which notice and comment would normally be required, irrespective of whether notice and comment is waived, is reserved for the Secretary. Any prior delegation of rulemaking authority, including the authority to sign or issue a rule or a proposed rule, is rescinded
Now, there’s a lot of disagreement about just what that means. The New York Times, in that link above, says that this change has been talked about for some time and is an assertion of HHS power over FDA decisions – and furthermore says that former FDA head Scott Gottlieb was fighting against such a change during his tenure. HHS has gone so far as to issue a statement trying to clarify this, saying that “The memo should have no effect on operational work and does not pertain in any way to guidances or any vaccine or drug approval or authorization. This action will not slow any HHS agencies’ work. It is simply the ministerial, administrative act of attaching a signature to a document“. The statement goes on to say that this will forestall challenges to regulations on the basis that the people issuing them did not have the proper authority to do so.
How often has that happened, exactly? And doesn’t that mean that any FDA approvals or rule changes will have no force unless the Secretary sees fit to attach that signature? Giving that Secretary that power to overrule them as he or she sees fit? And even if that’s not the memo’s intention – and I’m not convinced that it isn’t – wouldn’t this seem to be a very funny time to be promulgating such a rule, what with so many people worrying about what has been obvious political interference in the work of the FDA and CDC? And yes, I know that there will be people who will say that they haven’t seen evidence of such interference, but I’m not having it – look at the position the CDC has been put in, more than once, of having to say what the White House wants rather than what their own staff recommend.
And then there’s the case of Michael Caputo. He’s a political ally of the President who was put in as chief spokesman for HHS and is now taking medical leave after a bizarre Facebook rant where he accused the CDC of committing “sedition” against the president, that “the deep state scientists want America sick through November” and had earlier made comments about “ulterior deep state motives in the bowels of CDC”. I was actually not going to comment on this weird situation, figuring that Caputo himself had had some sort of breakdown, had apologized, and deserved a respite, but now I see that he’s publicly standing by his remarks and resents the idea that he has any sort of mental problems. So we should let him own this crap.
But why stop there when talking about political interference? The Times has also reported that the FDA is planning stricter guidelines for coronavirus vaccine approval, including clearer cutoffs for efficacy, separate advisory committee meetings for each vaccine, etc. But yesterday, the president let it be known that he doesn’t necessarily want anything of the kind:
That has to be approved by the White House,” he said, adding, “We may or may not approve it.” Raising questions about why vaccine makers would want to delay the process, he said, “We are looking at that, but I think that was a political move more than anything else.”
“We are looking at that” is one of Trump’s tropes, along with “many people are saying” and how everything is coming in two weeks, etc. But the suggestion that the FDA (and the drug companies themselves?) are deliberately dragging their feet on a vaccine is (A) wrong, (B) extremely harmful to public perception of the whole effort and to its eventual success, and (C) an insult that it itself beneath contempt. Oh yeah, and it’s (D) a direct slap in the face to Trump’s own FDA Commissioner, Stephen Hahn.
Earlier in the day, Hahn (and the heads of other agencies) had been in front of Congress, saying that they would not allow political pressure to take over from a scientific evaluation of the vaccine work. And Trump’s statement is what he gets for his trouble. The honorable thing to do would be to resign, honestly, but working for Donald Trump often seems to put people in a position where they feel that doing the honorable thing is an option that’s been closed off. Will Hahn stick up for his agency now? Or can he, since Sec. Azar has said that he has to sign off on anything of any importance? What a mess. What an absolute mess, and it didn’t have to be this way. None of it had to be this way.