Ayelish McGarvey is back with a follow up to her piece in The Nation on Plan B, which was the subject of a previous piece here in THCB.  The new piece called Plan B for Plan B explains the weird double application for joint "behind the counter" and prescription status, and suggests that it cannot be signed off on by FDA lawyers. She continues her thesis that this is mostly Galson’s fault. Robert Steeves is not so sure. He writes

There is nothing in the Ayelish McGarvey piece that went unconsidered in my piece.  I think she is wrong on the Galson "acting alone" and apart from Crawford. A new guy just appointed in a ‘acting’  capacity just would  not step out on his own and create this national storm certain to reach the White House.  Give me a break.  This casts Galson as a "suicide bomber" ready to sacrifice self for the cause (a certifiable disqualification to lead CDER if there ever was one). 

For sure, most FDA lawyers would not "sign off" on the distribution scheme, but who says they must. They are not barriers to a decision(unless the decision-maker wants a place to hide) but advisors. This is illustrated by the line authority for the lawyers at FDA coming from the HHS General Counsel, not the Commissioner. Usually, a legal warning that "if you go there, you are on your own legally" is enough to scare any one into a "revise" this policy mode, but it need not be.  Somebody at FDA must have a reasonable rationale for legal support for the policy which neither Barr nor FDA has revealed. However, this overlooks the possibility that the Bushites do not intend Plan B OTC to be approved in any event under any theory. 

As we will see with the State Law workarounds for Plan B, the first "religious right" lawsuit is likely to overturn any state law giving Plan B OTC status under the Federal Supremacy Clause of the U.S. Constitution.  And the same legal challenge is sure to come to any "unconventional" Federal OTC approval scheme like the bifurcated OTC/Rx status pending.  FDA has raised the issue of the under 16 women as a safety problem, so it seems unlikely that it can now go back and "admit error" to permit a legally correct approval.

If State Plan B workarounds were doable, we’d have marijuana, laetrile, and lots of other substances legalized in many states. No one can establish that Plan B is not in "interstate commerce", no matter where it is distributed today. The States work under the police power(denied the Feds??) to protect their citizens. In the past, this has meant a State can more rigorously regulate a drug product, but cannot relax that status. Perhaps the argument will be that a State "must act to provide Plan B to better protect its women and citizens because the Fed’s have failed to do so and . . . . .(this is the tough part).

Barr CEO Bruce Downey says Barr may turn to the States to get Plan B on the market but he is a lawyer and should know all the above. Importantly, I have never heard or seen him expound on his "legal rationale" for this position.  Nor can I understand Barr’s strategy in raising this faux solution unless, like Galson, he has some secret ally that we have not yet heard  about.

As for Hager, thanks to Ayelish McGarvey’s earlier article, we now know he’s a hypocrite or worse.  But I think she fails to understand the basic principle involved in both cases — do not put much weight in what is being said, watch what they actually do.  And FDA has not, and will not, approve Plan B.  The Congress might have a case to legislate the approval if it is to be done at all.

A little more about my FDA article from Monday….

Prospect/Nation journalist Ayelish McGarvey, who wrote the article about David Hager, and knows way more about Plan B than I’d ever want to, says that I (and by implication Robert Steeves who’s earlier article on Plan B I lifted for THCB) don’t actually understand what’s really going on with Plan B’s non-approval. She tells the real story in a long comment to my piece over at Ezra’s blog.

Essentially Barr’s first application to make Plan B available OTC was turned down. The delay in approval, over which the three Dem senators are holding up Crawford’s nomination is for a second application in which Barr Labs asked to put Plan B behind the counter for women over 16 years old and by prescription only for those under 16. FDA hasn’t approved drugs in that manner before, and its lawyers won’t sign off. To know more we need to wait till McGarvey’s article comes out (next week), but it’s clear that in her view, Steven Galson, the director of the Center for Drug Evaluation and the surprise signatory to the original non-approval (the one that turned over the 23-4 scientific vote in favor of approval) acted more or less independently from Crawford. It’s certain that he went against the staff scientists advice. This is what it says on the FDA page about Plan B:

12. Dr. Steven Galson signed the letter FDA sent to the sponsor. Does Dr. Galson usually sign such letters? Why did Dr. Galson sign the letter?No, Dr. Galson does not usually sign regulatory action letters. However, his opinion of the adequacy of the data in young adolescents differed from that of the review staff. He believes that additional data are needed and for that reason he made the decision to take final action within the Office of the Center Director.

And the differences between the political leadership of the bureaucracy and the staff are huge. Meanwhile there is a pretty good article which I missed at the time in the NEJM on what happened, and another blog, The CarpetBagger Report, picks up the story from what Jon Cohn wrote in TNR.

On the other hand, I really only wanted to make two points about the FDA.

First, there are fundamentalist loons with an agenda inside FDA (i.e. whoever it was inside FDA who asked Hager to provide a dissenting opinion), or at least those who want to air the fundamentalist loon’s opinions. I can never tell if its the fundamentalist loons using the cynical rightwingers or the other way around, but their views are clearly being heard and acted upon.

Secondly, forgetting Plan B — which in the grand scheme of things is just another story of how screwed up sex education and reproductive health in this country have become — the issue of whether FDA can be trusted on pharma safety overall is still a complete mess. That cannot change unless we get a total change in the current regime at FDA including Crawford, Galson and anyone else favoring either fundamentalist loons or the short term interests of big pharma over full disclosure about drug safety. I know that Ted Kennedy (and by Ayelish’s implication Sens Clinton and Murray too) have given up on trying to fix that, but someone needs to be reminding the American public about it!

And, for the nth time, full disclosure about drug safety may lead to people taking drugs that could be considered dangerous.  Some people might want to take a Cox-2 and trade off pain relief for a higher chance of heart disease.  But the key is that they need to be sure that the FDA is making all the information available — and that’s where it’s fallen down on the job and lost the public’s trust. And in the end it’s better for big pharma to be in a market where the public trusts what the government says about their products.

On another topic, talking of what pharma says about its products, the Washington Legal Foundation, which got DTC ads on TV in the first place, is causing a little more fuss in that arena.