PHARMA/POLICY: Was Plan B Crawford’s ‘Plan B’ for Commissioner?

Ex-FDAer Robert Steeves has this fascinating look at how Lester Crawford made it to the FDA Commissioner’s office despite being largely responsible for the FDA’s lack of activity and failed response to the COX-2 acopalypse. This is a re-print from FDAweb, which I would encourage you to  subscribe to (although it’s not cheap so it’s probably best if someone else is picking up the tab!)  Thanks to FDA Web publisher Jim Dickinson for permission.  As you might suspect with this Administration, it looks like political payoffs have triumphed over scientific integrity and commonsense

Looks like the true story of Lester
’s apparent triumph over conventional wisdom may be seeping out —
the only way most delicate information can get out of FDA. And it looks like a
good, old fashioned, political payoff. There are just too many “firsts” and too
many Plan B’s here to ignore.

Consider the emerging scenario as

In 2002, the White House considers Crawford for commissioner
and backs off for reasons never explained. Perhaps someone discovers that in
1985 the House Committee on Government Operations unanimously found that
then-CVM director Crawford “actually fostered the illegal marketing of
unapproved drugs,” failed to discourage the illegal use of drugs that tainted
the milk supply, failed to remove drugs from the market that had been proven
unsafe and approved drugs that his staff members suspected were carcinogenic.
Significantly, the committee found Crawford had disbanded an independent drug
safety group for humans within his Center because, as he then stated, “it is now
our job to approve drugs.” Internal reports warned that this move would
undermine safety concerns, hearings found.

Apparently concluding that Crawford could not be confirmed as FDA
commissioner in 2002, the White House instead names him deputy commissioner,
which many assume means de facto commissioner because popular wisdom is, and I
agree, that no nominee will be put up for confirmation to the top job. It makes
good sense — Senator Edward Kennedy,
the ranking Democrat on the Senate HELP Committee, has been threatening to
vigorously oppose any candidate with prior industry ties, and so placing
Crawford in a post not requiring confirmation avoids that obstacle without
changing substance. Anyway, FDA has no raging controversies and there are more
important issues facing the White House.

But FDA constituencies begin a steady drumbeat for a “permanent” FDA commissioner and
along comes Mark McClellan, a
physician with a business degree too, already serving in a presidentially
appointed and confirmed post, and he zips through the confirmation process but
sticks around for only 10 months before moving off to the Center for Medicare
and Medicaid Services. So, back to “Plan B” (leave Crawford as deputy and make
him the acting commissioner again.

Fast-forward to 2004 and the White House is looking at the potential of a
tough reelection race for the president, and there is unrest among the religious
and conservative base that Bush is not being sufficiently sensitive to their
concerns. Just when he needs least, Barr Laboratories provokes the
conservative/religious base with an NDA for an over-the-counter alleged
instant-abortion “morning after” pill, Plan B.

The nCDER review staff’s recommendation is favorable, the advisory committee agrees
23 to 4 and the decision gets kicked up a notch. CDER director Steven Galson “consults” with the Office of the Commissioner, FDA’s command center for political inputs. Why does
he do this, if as everyone later insists, the decision on Plan B is “purely
scientific” with no political considerations? He comes away from the
consultation and decides not to approve Plan B, saving the day for the White
House, intentionally or not.

To soften the blow for Barr, Galson suggests more “scientific” studies on the
“complex” question of how to assure that girls under 16 (not previously studied)
might handle Plan B and how to prevent them buying it if were available OTC.
Nobody but the religious far-right buys this subterfuge and political flak from
liberals gets into high gear as the election nears.

Meanwhile, the Vioxx withdrawal, the winter flu vaccine debacle,
whistleblower David Graham, and
associated pressures turn up even more heat on the White House for putting in a
permanent commissioner. Assessments on who the White House will nominate
universally discount him because he’s been the one in charge when the
controversies exploded, and because he has been passed over by the White House
before as being too provocative to the Kennedy crowd — notwithstanding the loyal
endorsement of his original champion, then HHS secretary and White House ally Tommy Thompson, or the rapidly
deteriorating situation at FDA under his management.

Wrong!!! Conventional wisdom forgets the “Plan B” political chit still
outstanding. When the president and the White House needed a “signal event” to
shore up the conservative base in the election campaign, who took the risk of
standing against the CDER drug review staff and the advisory committee’s
provocative recommendation — the first FDA head to do so that I can recall — and
save the day with the conservative base?
This is the scenario that is in the air. All the pieces make sense now and only if you
use all of these pieces. You do not have to have the political insights of a Karl Rove to put this together, but he might be a key witness in getting to the bottom of this.
When chairman Mike Enzi
reconvenes his Senate HELP Committee this week to examine the “unique and
confidential complexities” of Plan B, it ought be an open hearing, with sworn

What can be so secret about these machinations? To the extent that
there might be some trade secrets to protect, Barr CEO and chairman Bruce L. Downey — whose company surely has little to thank the Bush Administration for in this episode, given the profits lost by Plan B’s much-delayed launch — might waive any objections or
assertion of confidentiality, to permit the questions and explanations to be in
an open forum, especially if the witnesses risk perjury for false or misleading
statements. Mr. Downey has shown himself to be an innovative leader in the past
and he, too, might want to have this issue put to rest.
Is Plan B Crawford’s own “Plan B” route to the post that he lost in 2002 and that
conventional wisdom was sure he would otherwise have been denied? The Bush White
House values nothing higher than this kind of loyalty.

Neither science nor common sense can suggest any better explanation for this series of