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
April 10th, 2012
April 3rd, 2012
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.
March 27th, 2012
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
March 21st, 2012
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
March 19th, 2012
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.
March 16th, 2012
March 13th, 2012
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
March 7th, 2012
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
November 14th, 2011
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