1/21/2010
[Commentary by Jim Dickinson*] Enforcement is up, but despite an apparent rising tide
of industry worry about what this means, the regulatory culture deep inside FDA now continues to be far more pro-industry
than it has been at any time since my close-up observations began in 1975. Few today remember the battles industry waged
against strident, Goddard-inspired, demanding drug reviewers like cardio-renal chief John Harter and against the notorious “drug lag”
in which the U.S. seemed to always be the last country to approve every new drug. Carter Administration chief counsel Nancy
L. Buc frequently extolled the virtues of the “healthy tension” that was supposed to exist in the arm’s
length relationship between regulator and regulatee.
Since the Reagan Revolution started dissolving
that “arm’s-length” posture, the ingrown skepticism, even occasional hostility, with which key staff regarded
industry has progressively eroded. Political appointees like Reagan deputy commissioner John Norris made
it respectable to publicly visit and bestow fulsome praise on such worthy companies as the then much-favored Merck, while
his boss, Frank E. Young, minted personal FDA bronze medals of appreciation which he passed out at industry
meetings and other venues.
It wasn’t just high-level window-dressing, either. Lower-level staff migrations
began between industry and FDA, ending the prior policy of keeping industry personnel remote from agency employment opportunities.
CVM’s director of compliance came directly from regulated industry, as did bench scientists and product reviewers.
FDAers had long been recruited by industry, just as they are today, but the flow wasn’t supposed to go the other way...
Read full report at FDA Webview (www.fdaweb.com).
