FDA ‘Smoke and Mirrors’ — Obama’s Inability to Change an Agency5/14/2010 “Change” was
what drove Barack Obama into office, and his inability to materially change agencies like FDA may be what
drives him from it in 2012. The key and talented people he sent there, like most of their counterparts from prior administrations
of both parties, lacked the raw, brutish determination to avoid being captured by an agency bureaucracy that has seen so
many would-be reformers come and go. Take, for instance, the issue of regulatory enforcement. After 30 years
of a relaxed, industry-enabling and “get government off the backs of the people” Reaganesque policy that infused
the regulatory enforcement culture in Washington, where is FDA? Behind the 8-ball, say many. Apart from raising the rhetoric
and a 50% jump in Warning Letters, Obama’s team at FDA has in 18 months introduced nothing of a true “reforming”
nature for the front-line troops in the field. ... Read full report...
Woodcock Sees Big Impact from ‘Comparative Effectiveness’ Unit04/20/2010 A feature of the Administration’s recently-enacted
healthcare legislation calling for establishment of a Patient-Centered Outcomes Research Institute has received little attention
by the public, but may yet hold major implications for FDA and the pharmaceutical industry, according to CDER director Janet
Woodcock.... Read More
FDA Defends Use of OCI Agents in Employee ‘Conduct’ Probes3/26/2010 Barely three months after the Government Accountability Office faulted FDA’s oversight and management of its Office of Criminal Investigations (OCI) and Office of Internal Affairs (OIA) — and the agency’s parent
HHS agreed — FDA 3/24 staunchly defended the way those offices conduct investigations of employee misconduct. In a six-page letter to House Energy and Commerce ranking member Joe Barton (R-TX), who believes use of criminal investigators
to investigate non-criminal allegations and whistleblowers is intimidatory and bad for morale, FDA ignored the morale issue. ...Read More...
FDA Ad Division Shows No Slowing Down02/04/2010 Fresh on the heels of last year's record setting pace for citing drug manufacturer advertising
and promotion violations, FDA's drug advertising division is at it again 2/3 with the release of four new violation
letters to industry. Read More ...
Courts Struggling to Apply FDA Preemption Decision01/29/2010 When the U.S. Supreme Court ruled in Riegel v. Medtronic that many state tort claims
against manufacturers of FDA-approved (premarket approval) medical devices are preempted by federal law, it didn’t
give clear guidance on which types of cases may still proceed in litigation. As a result, lower federal courts are struggling
with the issue and have reached varying conclusions, according to an analysis by attorneys Steven Ellison, Peter Goss, and Joe Wearmouth (all Faegre and Benson). Read More...
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