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Posts Tagged ‘FDA’

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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On Plan B, Did Secretary Sebelius Go Back on a Promise?

In December, Department of Health and Human Services Secretary Kathleen Sebelius overruled scientists and ordered the FDA to refrain from approving “Plan B” emergency contraception for over-the-counter use. I’ve been back through what Secretary Sebelius has said about how science should inform FDA decisions, and found this in her testimony before the Senate during her confirmation hearing in 2009:

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Categories: Scientific Integrity  

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Science Advocates Tell PCAST to Engage on Scientific Integrity

Today, along with four others, I testified before the President’s Council of Advisors on Science and Technology, popularly known as PCAST. The topic: the administration’s failure to follow the law and allow over-the-counter access to Plan B emergency contraception. Read More

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Webcast Tomorrow: The FDA, Prescription Drugs, Medical Devices, and Science

It’s mind-boggling to me that the U.S. Food and Drug Administration oversees items accounting for 25 cents of every consumer dollar spent. That’s a lot of stuff. Read More

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Engaging Public Health Scientists at the APHA Meeting

This weekend, thousands of public health scientists descended on Washington, DC, for the annual meeting of the American Public Health Association. They’ll be here through Wednesday, sharing cutting edge research on everything from occupational health to epidemiology to HIV. And UCS scientists and outreach staff will be out there in full force. Read More

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