October 27, 2010 |
It’s no secret that the public health regulatory apparatus is stretched thin in many places, perhaps no component more so than the woefully understaffed food inspection side of the Food and Drug Administration. But say this for the FDA food police: When they do get around to looking a place over, they pay loving attention to detail. Acting on a court order sought by the FDA, U.S. marshals today seized an estimated $700,000 worth of adulterated rice and other food packaged in (unfortunately)
October 31, 2013 |
The U.S. Food and Drug Administration announced Thursday that it was stepping up efforts to prevent and address prescription drug shortages, calling the shortfalls a significant public health threat. In addition to expanding early reporting requirements for drug manufacturers, the FDA said it was launching a smartphone app that would give consumers instant information on pharmaceutical shortages. "The complex issues of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
July 13, 2011 |
WASHINGTON – Following a spike in reported complications, the Food and Drug Administration released an updated advisory Wednesday about a surgical mesh implanted in women to strengthen vaginal tissue that can become weakened, especially after childbirth. In its report, the FDA says a review of industry literature and the adverse event reports has shown little evidence that the device, which is implanted vaginally or abdominally, improves pelvic organ prolapse, where a woman's uterus, bladder, or rectum can slip out of place.
July 8, 2013 |
In a recent post , I noted the Catch-22 that the Supreme Court insists Congress created with its fast-track approvals for generic drugs. Those who are injured by a brand-name drug can win compensation from the manufacturer if they can show the drug was unreasonably dangerous or that its warning label didn't disclose the risks properly. But those injured by a generic medicine can't hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.
April 13, 2012 |
The U.S. Food and Drug Administration's proposal for voluntary guidelines that would wean livestock off growth-inducing antibiotics left foodies and public health officials disappointed this week. “Nonbinding recommendations are not a strong enough antidote to the problem,” argued Rep. Louis Slaughter (D-N.Y.). Avinash Kar, public health staff attorney for the Natural Resources Defense Council, replied to the news with a statement equivalent to an eye roll: “We've essentially had a voluntary measure in place for 35 years since FDA first acknowledged the risks of using antibiotics in livestock feed, and we have seen the use of antibiotics grow exponentially in that period.” Food Politics' Marion Nestle was also frustrated: “I'm guessing this is the best the FDA can do in an election year,” she lamented , saying the proposal looked more like a “direct challenge to drug companies and meat producers to clean up their acts” than a real solution.
April 23, 2011 |
The FDA is asking companies that make painkillers to create educational materials, written in simple language, on how to safely use and throw away opiates as part of the government’s new effort to curtail prescription drug abuse. Opiate-drug makers will also have to propose a plan in 120 days on how they will train doctors to manage pain and screen patients, the FDA announced Tuesday. Certain drugs the companies sell are being...