The White House Plan To Combat Antibiotic Resistance
There has been much press lately about President Obama’s plan to address the growing crisis of antibiotic-resistant bacterial pathogens. And I agree with many that there is much to like in the plan. But I also find a number of key deficiencies that will lead us nowhere.The goals of the plan are all laudable –
AstraZeneca's Antibiotic Spin Off
I just came back from Boston and the annual meeting of BAARN – the Boston Area Antibiotic Resistance Network symposium held at the Broad Institute. The meeting was interesting but the atmosphere was funereal. Many of those losing their jobs with the closure of Cubist’s research center in Lexington, Mass were there as were many whose jobs are threatened at AZ’s facility in Waltham, Mass. One major topic of discussion during the breaks was – where will all the antibiotic research go?
FDA Panels: Conflict Of Interest Vs. Competent Advice
Recently a study was published in the Milbank Quarterly analyzing the voting patterns of FDA Advisory Committee members with apparent conflicts of interest.
In The Antibiotics Game, It's The EU 21 - US 0
Europe is so far ahead of the US in its thinking on
antibiotics and antibiotic resistance that we should all be ashamed. For the
last 15 years, Europe has led the way on the regulatory front making antibiotic
development a top priority for its regulatory body the European Medicines
Agency. None of the recent US
administrations going back to Bill Clinton nor the FDA itself ever made such a
statement nor have they acted in a way commensurate with this thinking.
FDA’s Pathway For Hospital Acquired Pneumonia - It's Feasible But Stupid
The FDA released its long-awaited Draft Guidance on hospital-acquired pneumonia recently. Their guidance has not changed since I wrote a blog about my last meeting with the FDA antibacterial drug development task force back in September of last year.To reiterate what I stated back then . . .
