Congressional investigators say the Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients' lives.
Today's report from the Government Accountability Office also shows that the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits -- even when such information is more than a decade overdue.
When pressed about that policy, agency officials said they have no plans to get more aggressive. The GAO says the FDA should do more to track whether drugs approved based on preliminary results actually have lived up to their promise.
The FDA says the report paints an overly negative picture of its so-called "accelerated approval" program, which is only used to approve drugs for the most serious diseases. The agency says that "Millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments" thanks to the program.
U.S. Health and Human Services Secretary Kathleen Sebelius reiterated Tuesday that she won’t intervene in the “incredibly agonizing” case involving a 10-year-old Pennsylvania girl who is waiting for a lung transplant, telling members of Congress that medical experts should make those decisions.
One of the first provisions of the 2010 health reform law has had its intended effect: shifting costs from hospitals, taxpayers and families to health insurance companies, researchers reported on Thursday. It’s one of the most popular aspects of the law.
People may realize that fast food isn’t health food, but they don’t realize just how fattening it really is, researchers report. They surveyed people eating at 10 burger, chicken, sandwich and doughnut chains and found they greatly underestimated just how much they were chowing down.
A new line of caffeinated chewing gum is causing jitters among health advocates and prompting federal officials to take a new look at the proliferation of jolt-infused foods, including those marketed to children and teens.