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 Crawford’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 follows:

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 witnesses.

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 decisions.