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PHARMA/POLICY: Steeves responds to McGarvey

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.

In any event, the interests of science and women’s health are not at the forefront of this FDA decision.

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