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Posts Tagged ‘conflicts of interest’

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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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 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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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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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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