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Posts Tagged ‘FDA’

The Human Cost of FDA Decisions: For a Midwestern Family, A Breakdown in Drug Safety Hits Home

The consequences of unsafe drugs and medical devices are real—and nobody knows that better than Gwen B. of West Sacramento, California. We talked a few days ago after she responded to a UCS action alert with a story about her mother, Maxine, and I was moved enough to want to share her family’s story with you. Read More

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New Allegations of Political and Corporate Pressure on FDA

In today’s New York Times, Gardiner Harris describes tensions between the FDA, Congress and the White House regarding the agency’s attempts to inform and protect the public. It’s an incredible article that helps demonstrate the pervasiveness of both political and corporate pressure on the agency, and how those who do not have scientific training in public health attempt to take decision-making authority on what should be scientific issues away from those who do.

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Money Talks, and What It’s Saying May Harm the FDA

Any way you look at it, $700 million is a lot of cash. That’s the amount that industries regulated by the FDA have spent since 2009 lobbying Congress and the Executive Branch. That investment is paying off as Congress now considers must-pass legislation that governs how the FDA uses science to evaluate prescription drugs and medical devices. Read More

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Three Myths about How the FDA Drug Approval Process Works

So far, we’ve provided general background on the FDA’s responsibility to ensure the safety and efficacy of prescription drugs. We have explored how the drug approval process works and examined what happens when the drug safety system breaks down. And we have looked at the importance of truly independent scientific advisory committees to the FDA’s ability to protect the public. Read More

Categories: Scientific Integrity  

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Five Reasons Congress Should Support Strong Conflict-of-Interest Standards at FDA

As I’m sure you’ve noticed, we have been blogging quite a bit recently about the FDA. This corresponds to legislation that would determine how the FDA approves and monitors drugs and medical devices. But why have we been so focused on reducing the number of FDA advisory panel members who have financial conflicts-of-interest? Read More

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Where the FDA Turns When It Needs Scientific Advice

While there’s a wealth of scientific expertise inside the FDA and other federal scientific agencies, FDA’s scientific staff often rely on the advice of experts outside the agency to help them decide whether to approve a new prescription drug or medical device, or to recall a product or issue stronger warning labels when there are safety problems. Read More

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Vioxx shows what happens when the drug safety system breaks down

In a previous blog post, I explained the FDA’s complex process for approving drugs and medical devices. However, in many cases, pressure from commercial interests has broken down this process. The approval and subsequent recall of Vioxx took its toll on thousands of Americans, including my own father.

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How the FDA Drug Approval Process Works

Earlier this week, my colleague Michael gave some general background on the Food and Drug Administration and what Congress has to do this year to ensure that the agency can continue to ensure the safety and efficacy of prescription drugs and medical devices. Read More

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For Drugs and Medical Devices, It’s Still a Jungle Out There

When UCS started looking at the use of science at the FDA several years ago, I sat down and read The Jungle, which has been credited with prompting President Theodore Roosevelt to establish the first iteration of the Food and Drug Administration more than a century ago. The grisly descriptions of the Chicago meat-packing industry still conjure up vivid images in my mind.

We’ve made great strides over the past century in protecting the public from unsafe food products. But it’s an entirely different part of the FDA’s wheelhouse that will be taking center stage over the next two months: the regulation of prescription drugs and medical devices. Read More

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Survey: Despite Progress, FDA Scientists Feel Political and Industry Pressure

UCS released a survey of 997 FDA scientists this morning which found that while FDA leaders are working hard to boost scientific integrity at the agency, persistent interference by special interests continues to hinder scientists’ work.  The FDA responded quickly and reasonably, stressing its successes while acknowledging that improvements can and should be made. National Public Radio science reporter Nell Greenfieldboyce was first out of the gate with a quick summary of the findings and FDA’s response. Read More

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