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March 12, 2010
The Case For Outreach
Stopping Drug Safety Spin Cycle
Why the pharmaceutical industry’s ill-advised reliance on lobbyists will hamper its efforts to rehabilitate its reputation.
A Chance To Give Back
Toward A Global Safety Network
Pharmacovigilance outside the prosperous countries needs to be improved, says the British Medical Journal.
New Tools, More Trials?
Radical Drug Safety Shift
Proposed legislation would profoundly alter the U.S. drug safety landscape.
'Sentinel,' Other Tools Planned
FDA Outlines Major Safety Overhaul
The announcement by the FDA is an ambitious, major effort to reassure the public without explicitly committing the agency to yet another layer of regulation or any specific, lasting changes to how drug safety is reviewed after drugs are brought to market.
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A few years ago, thinking the way all journalists think, we had an epiphany. The reportorial brain is the one we’re happily stuck with. But it often adopts a harshly negative, critical outlook that transcends age, geography and political affiliation. We…
There is an article in the British Medical Journal related to international aspects of drug safety in the developing world. ”Pharmacovigilance in the Developing World,” written by researchers in England and Ghana (Munir Pirmohamed, Kwame Atuah, Alex Dodoo and Peter Winstanley),…
It’s impossible to predict how the PDUFA issue will play out this year. But the House bill 1561 has a number of interesting provisions. It was introduced last week by Henry Waxman and Edward Markey, two California Democrats and longtime critics…
FDA head Andrew von Eschenbach has proposed a partial adoption of Institute of Medicine recommendations about drug safety. The Duke Clinical Research Institute and Mortara Instrument (a European electrocardiogram firm) have been tapped as assisting the FDA in its safety push.…
Like the aftershocks from an earthquake, the political tremors after Vioxx don’t seem to subside. Yes, Merck’s strategy of swatting the pesky plaintiff lawyer-flies one at a time seems to be paying off. And yes, the FDA’s attempt to bolster its…
FDA has released a plan for enhancing drug safety. To pay for it, the agency has proposed a 29 percent rise in spending for a renewal of the Prescription Drug User Fee Act (PDUFA), from $304 million to $393 million. By…
