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Posts Tagged ‘prescription drugs’

As Obama Administration Folds on Emergency Contraception, A Full Timeline of Events

The Obama administration yesterday dropped its appeal of a judge’s order to follow the science and allow consumers full over the counter access to the emergency contraception known as Plan B. I never thought I’ve be invoking Kenny Rogers in a blog post, but somehow it now seems to fit: you gotta know when to hold ‘em. Know when to fold ‘em.The Obama administration should have folded long ago; for reasons unknown, it chose to stay in the game. In the process, it earned a serious black eye. Read More

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Appeals Court Rules Emergency Contraception Should Become Available Over The Counter

I’m at a conference this week but wanted to pass along some pretty big news on the Plan B emergency contraception saga, which keeps getting more and more strange. Read More

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A Roundup of Editorials Criticizing President Obama’s Plan B Emergency Contraception Decision

On Tuesday, District Court Judge Edward Korman spoke incredibly strongly against the Obama administration’s decision to appeal his order that would require the Food and Drug Administration to use science to determine whether over the counter access to emergency contraception is safe for women of all ages. Read More

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Duped Again on Emergency Contraception

I feel like Charlie Brown.

A few weeks ago, I celebrated as a federal judge ordered the FDA to follow the medical evidence and make the emergency contraception known as “Plan B” available over the counter without restrictions. Under both President Obama and his predecessor, the decision had been thoroughly politicized. I thought that the judge’s ruling would provide the Obama administration with political cover. Surely they would respect the decision. Read More

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Following Science, Judge Orders Over-the-Counter Access to Emergency Contraception drug Plan B

Chalk up a win for science. Federal Judge Edward Korman today ordered the Food and Drug Administration (FDA) to make “Plan B” emergency contraception available to women of all ages without a prescription, calling efforts to stop the FDA from doing so “arbitrary, capricious, and unreasonable.”

A federal judge has accomplished what two administrations failed to do: make a decision about access to a drug based on medical evidence. It’s just common sense for the government to make drug approval and access decisions solely based on the best available science, not on hunches or political calculations. The decision brings a decade of politics trumping science to an end.  Read More

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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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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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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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How Conflicted Experts Can Sway FDA Drug Approval Decisions: A Case Study on Yaz

Experts on FDA advisory panels with financial conflicts of interest can influence the approval of a drug in multiple ways, not only by voting to approve a drug but also by dominating the discussion and pressuring other panelists. In the case of the popular contraceptive drug Yaz, four scientists with financial conflicts of interest were enough to push the vote in favor of the drug, with significant consequences for some women. Read More

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The Human Cost of FDA Decisions: For Dan and Elsa, Life Depends on Safe Medical Devices

Yesterday, I shared the story of a UCS supporter whose family had experienced tragic consequences when unsafe drugs were allowed on the market. But drugs and medical devices, when adequately tested and monitored, do have the potential to vastly improve one’s health. For Dan O. of Norwalk, CT, medical advances in the treatment of the coronary system have been lifesaving.

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