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Posts Tagged ‘FDA’

Its Master’s Voice: The FDA’s Dependence on Drug Industry Fees

I’ve spent many years wondering why the Food and Drug Administration (FDA) has been so slow to curb the rampant overuse of antibiotics in agriculture. 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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Freedom to Tweet: Grading Social Media Policies in the Federal Government

Social media can transform debates, inform discussions and, as we saw with the Arab spring, help spread democracy. And information and science have a key role to play in democracy (hence the new Center for Science and Democracy here at UCS). Scientists working for government agencies such as NASA, NOAA, the EPA, and the FDA have a lot to contribute to discussions about the science-based challenges we face. Unfortunately, agency policies combined with a culture of timidity are often constraining individual government scientists from jumping into social media. Read More

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Weaker Antibiotic Regulation: Another Problem with FDA’s Voluntary Cooperation Program

Last post, I described some of the features of the voluntary process that might convince veterinary drug companies to give up lucrative approvals to sell antibiotics for production purposes, like growth promotion and feed efficiency. Read More

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Putting the Interests of Patients First: Conference Endorses Science-Focused Health Care

It’s not often that some of the best and most creative minds in medicine, medical ethics and healthcare all gather in one place. It’s even more rare when all these individuals are gathered together to focus on one problem—undue corporate influence on the treatment of patients in the U.S. Read More

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Negotiating with Drug Companies: The Horse-Trading Behind the FDA’s Voluntary Program

After decades of dragging its feet on the issue, the FDA has finally acknowledged that the ongoing massive use of antibiotics in food animal production poses a public health risk that demands a response. 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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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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