FDA: Agency Asked Pfizer To Resubmit ‘Large Number’ Of Chantix Adverse Reports
The Food and Drug Administration said it asked Pfizer Inc. (PFE) to resubmit a large number of adverse-event reports last year involving the company’s smoking-cessation treatment Chantix. The FDA said in a statement posted on its website Thursday that it became aware that Pfizer and a few other manufacturers the agency wouldn’t name were submitting […]
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New REMS for Avandia restricts access, signaling new way to restrict drugs from market
Last September, the FDA decided to allow the controversial Avandia diabetes pill to remain on the market. The move came after more than three years of debate over the cardiovascular risks of the which the GlaxoSmithKline drug and charges that the drugmaker failed to sufficiently disclose clinical trial data showing the magnitude of those risks. […]
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And The Global Outlook For Drug Spending Is…
To some, a forecast is an opportunity to see the glass as half full. To others, the glass may be half empty. Then again, it is just a stupid glass. Consider the latest projection from IMS Health, which offers some good news and bad news for just about everyone. In its most recent annual briefing, […]
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Media Does Poor Job of Disseminating Info on Pharma, FDA
FDA’s regulations, policies and actions are multi-faceted and complicated. Oftentimes, it is hard to interpret what the agency is doing and why. We all depend on good analysis to understand where the agency has been and where it is headed. Unfortunately, some of what we read about FDA is poorly reasoned or distorted by the […]
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The Merck Hepatitis C Med: Update
Late last week, the FDA approved a much-anticipated hepatitis C treatment from Merck, which the drugmaker inherited as part of its acquisition of Schering-Plough. The move, which is the first FDA endorsement of a new hepatitis C med in a decade, came just 10 days before Vertex Pharmaceuticals is expected to win approval of its […]
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FDA Issues 5 New International Warning Letters
The “Most Recent Warning Letters†section of the FDA website lists five Warning Letters to international firms. The Warning Letters were posted on May 10 and will disappear into the Warning Letter labyrinth on the website in a few days (see previous post). They are to firms in both Europe and Asia and come from […]
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FDA: For Corrective Action Plans, Where are the Resources?
Can you imagine the stream of firms that venture in to their respective FDA district offices to give presentations on their Warning Letter response and to offer their assurance that they truly “get itâ€? You can be sure that theses firms had several dry runs and dress rehearsals to hone their material before stepping into […]
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Will Pfizer Pay $2B To Settle A Protonix Probe?
Two months ago, Pfizer disclosed that talks are under way with the US Department of Justice to settle charges the drugmaker committed fraud against government health programs by failing to report discounts and rebates for its Protonix heartburn med. And at the time, Pfizer also disclosed the feds alleged its potential liability is more than […]
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FDA’s Warning Letter “Close-Out†Process Is Not Working
In an August 2009 speech to the Food and Drug Law Institute, FDA Commissioner Margaret A. Hamburg, M.D., emphasized the importance of enforcement (see our previous post here). Among other actions announced by Dr. Hamburg was a warning letter “close-out†process. Dr. Hamburg stated that “[i]f the FDA can determine, usually based on a re-inspection, […]
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Genzyme Charged With Double Standard By Patients
In the latest flap over Genzyme, its ongoing manufacturing problems and subsequent product shortages, a group of Fabry patients are charging the biotech has employed a double standard when it comes to providing its Fabrazyme med to US patients and those in Europe. New Webinar – July 28 – Dangerous Documents: How to Avoid Landmines […]
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