Insight: In PIP implant scandal, a ragged safety net exposed
In June 2000, when American medical regulators posted a warning letter on the Internet about problems at a breast-implant maker in southern France, French authorities didn’t pay much attention. A U.S. Food and Drug Administration (FDA) inspection had found some products manufactured by Poly Implant Prothese (PIP) were “adulterated,” the letter said. French regulators say […]
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Whistleblowers accuse FDA of spying, persecution
The US Food and Drug Administration (FDA) is being sued by its own scientists and doctors who allege they were spied on and persecuted by the agency for expressing safety concerns about the approval of medical devices. This legal action has prompted an investigation by a key lawmaker in the Senate. It’s claimed that the […]
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Drug Shortages Cause Cancer Patients To Die Sooner
This may not come as a surprise, but the ongoing shortages of various prescription drugs – notably, injectables that are used to treat assorted cancers – are not only preventing patients from receiving timely or the most appropriate treatments, but patients are dying sooner than they would otherwise and tumors are recurring more often, according […]
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FDA Commish: COI Rules Should Remain Intact
Six months after telling Congress that the FDA may loosen conflict of interest rules because finding qualified experts to serve on advisory committees has become increasingly difficult, FDA commish Margaret Hamburg has issued an about-face and now says the rules should remain intact. She confessed her change of heart before a House committee hearing yesterday […]
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Pfizer Cites Packaging Flaws in Birth-Control Pill Recall
Drug maker Pfizer Inc. recalled about a million packs of birth-control pills that weren’t packaged correctly, which raised the risk of unplanned pregnancies among women who relied on the pills. Pfizer Inc. is recalling about a million packages of two types of birth-control pills because they might not contain enough pills with active ingredients, Jennifer […]
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FDA Review Deadlines Caused Safety Issues: Study
The latest buzz about the FDA is that the agency is approving more drugs in the past and, the trend has been especially noticeable in recent days with the approval of several medications, including a new type of treatment for some people who suffer from cystic fibrosis (see here and here). But what if the […]
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About Those 7,300 AstraZeneca Job Cuts…
And so, the drugmaker is, indeed, eliminating thousands more jobs, as reports indicated earlier this week. Where will they be coming from? Well, 3,750 jobs are being slashed from sales and marketing and assorted administrative operations. Another 2,200 positions are being eliminated from R&D and the remaining 2,200 will come from operations, as more supply […]
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The Pfizer Generation: Who Pays For The Babies?
About nine months from now, a new phenomenon may appear at a hospital near you: the Pfizer baby. Why? The drugmaker has taken the embarrassing step of recalling 1 million packets of birth control pills due to a packaging error. Some blister packs may contain an inexact count of active ingredient tablets and, as a […]
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Grassley Probes FDA Over Employee Whistleblowers
How does the FDA treat employees who blow the whistle? US Senator Chuck Grassley, a long-standing agency nemesis, wants to know. And so he has written FDA commish Margaret Hamburg to explain the circumstances surrounding a controversial episode in which several current and former agency employees say they were harassed and dismissed after complaining about […]
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Whistleblowers Sue FDA, Claim Emails Monitored
Six former FDA scientists are suing the agency, saying it unlawfully monitored personal email accounts from their work computers after the scientists complained to Congress about allegedly unsafe medical devices gaining approval. According to the Washington Post, scientists and doctors within the Center for Devices and Radiological Health (CDRH) first made internal complaints starting in […]
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