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Posts Tagged ‘FDA’

FDA Gets it Right as Merck Suspends Sales of Cholesterol Drug Tredaptive

The drug company Merck is suspending sales of its cholesterol drug Tredaptive and asking doctors not to prescribe it due to the drug’s ineffectiveness and some non-fatal side effects. What’s most interesting here to me is that U.S. consumers have nothing to fear: the drug was available in the European Union, but not here.  FDA scientists rejected it in 2008. Read More

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Compounding The Problem

If you want to see what a world without regulatory safeguards looks like, you don’t have to look far. The current and evolving outbreak of fungal meningitis tied to one large compounding pharmacy in Massachusetts is a case study in what happens when state and federal regulators fail. It also shows what can happen when conflicts of interest get in the way of regulation based on the best available science. Read More

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Fixing an Obama Administration Mistake on Emergency Contraception and Science

Today marks the one-year anniversary of the Obama administration’s decision to prevent the FDA from using the best available science in evaluating the emergency contraception drug Plan B. It was a setback in the Obama administration’s pledge to restore science to its rightful place and listen to scientists “even when it is inconvenient–especially when it is inconvenient.” In the interim, evidence has been mounting that the administration’s decision has placed unnecessary barriers to access to Plan B. It’s time for the administration to allow the FDA to revisit the decision. Read More

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Congress Does Something Right — For Federal Scientists

Today, Congress did something good for the American public and good for science. After a 14-year struggle, the House and Senate approved a bipartisan whistleblower protection bill that will make a difference to all federal workers, but that should be especially welcomed by federal scientists. Read More

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Woody Guthrie’s Birthday and the War on Cynicism

In our fight for a better quality of life for all Americans, we need storytellers. We need to reach people through personal anecdotes, through editorial cartoons, through songs. We need to arm people with narratives of what is possible, so that together we may be successful in spurning the cynicism that supports the status quo and disillusions the disempowered. And few have done this better than the man who would have turned 100 years old tomorrow: songwriter and American folk hero Woody Guthrie.

But what do Woody’s writings have to do with science? As it turns out, plenty. Read More

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The Future Health of Scientific Integrity is at Stake in New FDA Law

The news these days has rightly focused on the Supreme Court’s landmark decision on access to health care.  But with scant media attention, Congress on June 26 sent a bill to the President that is just as important  to the health and well-being of each and every American family, and the future of scientific integrity at the Food and Drug Administration. Read More

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We Found Independent Experts—the FDA Can Too

Pharmaceutical and medical device companies, and some in Congress, argue that it’s difficult to find independent experts to serve on FDA’s scientific advisory committees due to strong financial conflict of interest standards.

Our experience proves otherwise. Read More

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New Report Details What Should Happen When Scientists at FDA Disagree

Should scientists at the Food and Drug Administration be able to have honest disputes with their colleagues about the science behind a drug or medical device approval decision? Or should they keep quiet about their concerns, preferring not to rock the boat? Read More

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For Sara, Faulty Medical Device Leads to Unnecessary, Invasive Surgery

Along with Gwen, Elsa, and Henry, another UCS supporter shared his family’s experiences with unsafe drugs and medical devices: John M’s daughter, Sara, has had needless complications with medical devices in her heart. Read More

Categories: Scientific Integrity  

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Study: FDA is Faster than Europe, Canada in Drug Approvals

In the New England Journal of Medicine this week, scientists from Yale University published research finding that the Food and Drug Administration approves drugs faster than its counterparts in Canada and Europe. (Media coverage is here and here.) The study reinforces the fact that FDA can approve drugs with relative speed while putting the safety of Americans first. Read More

Categories: Scientific Integrity  

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