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.
June 28, 2013 |
Is it hot in here, or am I just depressed? For many menopausal women, hot flashes are just depressing. And depression, which affects at least one in four women ages 40 to 59, can intensify the misery of hot flashes, as well. No surprise, then, that a pharmaceutical company came up with the idea to market an antidepressant for treatment of vasomotor symptoms, a.k.a. hot flashes. And on Friday, bucking the recommendation of its advisory committee on reproductive health drugs, the Food & Drug Administration approved the idea.
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...
March 11, 2014 |
The U.S. Food and Drug Administration has approved the marketing of an electronic medical device intended to treat migraine headaches. In an announcement released Tuesday, officials said the transcutaneous electrical nerve stimulation, or TENS, device was the first ever to receive such approval. The device, which will be marketed under the name Cefaly , is manufactured by Cefaly Technology of Belgium. "Cefaly provides an alternative to medication for migraine prevention," read a prepared statement from Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health.