Join
Search

Posts Tagged ‘medical devices’

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

Bookmark and Share

New Report Details What Should Happen When Scientists at FDA Disagree

Should scientists at the Food and Drug Administration be able to have honest disputes with their colleagues about the science behind a drug or medical device approval decision? Or should they keep quiet about their concerns, preferring not to rock the boat? Read More

Bookmark and Share

For Sara, Faulty Medical Device Leads to Unnecessary, Invasive Surgery

Along with Gwen, Elsa, and Henry, another UCS supporter shared his family’s experiences with unsafe drugs and medical devices: John M’s daughter, Sara, has had needless complications with medical devices in her heart. Read More

Categories: Scientific Integrity  

Tags: , ,   

Bookmark and Share

The Human Cost of FDA Decisions: A Faulty Hip Replacement Disrupts a Young Man’s Life

After sharing the personal experiences of two separate UCS supporters—Gwen and her mother, Maxine and Elsa and her husband, Dan–with drug and device safety, I’ve heard from others who are also brave enough to share their stories with us. Henry H.’s tale about his metal on metal hip replacement is particularly touching, showing how a faulty medical device can have consequences not just for the victim but for his entire family. Read More

Categories: Scientific Integrity  

Tags: , ,   

Bookmark and Share

The Human Cost of FDA Decisions: For Dan and Elsa, Life Depends on Safe Medical Devices

Yesterday, I shared the story of a UCS supporter whose family had experienced tragic consequences when unsafe drugs were allowed on the market. But drugs and medical devices, when adequately tested and monitored, do have the potential to vastly improve one’s health. For Dan O. of Norwalk, CT, medical advances in the treatment of the coronary system have been lifesaving.

Read More

Bookmark and Share

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

Bookmark and Share

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.

Read More

Bookmark and Share

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

Bookmark and Share

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

Bookmark and Share

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

Bookmark and Share