Posts tagged with ‘FDA’
The Department of Health and Human Services, the National Institutes of Health, and the Food and Drug Administration today announced a partnership aimed at speeding new medical treatments from “microscope to market,” as HHS Secretary Kathleen Sebelius put it. The program will help researchers conducting basic biomedical research understand the regulatory parameters for drugs and [...]
Fifty years after we figured out how to keep astronauts’ food from making them sick, the time has come to commit to keeping the rest of us as safe.
The Food and Drug Administration Transparency Task Force held the first of its two public meetings for public recommendations on how to increase transparency in decision making yesterday. At the meeting, Kristi Zonno, Director of Genetics and Health Policy at the advocacy group Genetic Alliance called for FDA to create a public registry of “genetic, [...]
Salmonella outbreaks from peanuts and tomatoes are scary enough, but consider the repercussions of contaminated medications people take several times a day. The Food and Drug Administration reported that 95 Americans died from ingesting tainted blood-thinning medication last year. The FDA believed the drug, heparin, was “intentionally contaminated” in China—a main source of counterfeit medicines.
The [...]
Just last week, the Food and Drug Administration announced that it would ramp up its transparency efforts, beginning with the creation of a task force focused on the issue. In keeping with other transparency efforts within the the new administration, the FDA now has its own transparency blog.
Paul Blumental explains the importance of the task [...]
Salmonella. Downer cows. More salmonella. The past year has seen several unpleasant and dangerous incidents of widespread food contamination. Today, Lyndsey Layton reports in the Washington Post that newly introduced Congressional legislation offers a slate of remedies to ramp up Food and Drug Agency capabilities for protecting the food supply. The draft legislation introduced in [...]
Shortly after being sworn in as the Commissioner of the Federal Drug Administration last Friday, Margaret A. Hamburg and her principal deputy commissioner, Joshua Sharfstein, described their plans to run the FDA as a public health agency in New England Journal of Medicine. The agency, charged with regulating much of the U.S. food supply, is [...]
Our guest blogger is Emma Diebold, intern with online communications at the Center for American Progress.
“Who is best equipped to protect the consumer from dangerous drugs and medical devices: regulatory agencies or the courts?” Mark Agrast, Senior Fellow at the Center for American Progress, asked a panel of experts during his introductory remarks at the [...]
The Associated Press reports that drug makers are quietly hopeful that recent appointments signal an agency-level bifurcation between food safety and drug safety responsibilities:
Drug industry advocates are quietly allying with some of their longtime critics pushing to split the Food and Drug Administration into two agencies, one for food safety and one for medical products.
President [...]
The peanut product recalls continue, revealing more cracks up and down the food safety system. And people keep getting sick.
A recent conference examining the legal protections corporations are taking to defend themselves in the event their products turn toxic should raise regulatory questions.
The Food and Drug Administration gave a thumbs up today for ATryn, a blood-thinning drug produced in the milk of genetically engineered goats. As we’ve previously described, it’s the first drug made in the milk of a farm animal to get U.S. marketing approval. (Most meds are made in chemistry labs or inside genetically engineered [...]
Food and Drug Administration Acting Director Frank Torti announced Monday in a podcast the creation of a new position in the Office of Chief Scientist: the Senior Genomics Advisor. Dr. Liz Mansfield, a scientist who has worked on scientific policy at both the FDA and in the private sector, will be the first to fill [...]
Members of Congress and others are calling for independent investigations into the federal oversight system for food production facilities in light of new revelations about chronic problems at the Peanut Corp. of America peanut-processing plant in Blakely, Georgia. Those calls are on target, and the matter deserves the attention of both the Justice Department and [...]
Okay, so according to the Lyndsey Layton in today’s Washington Post, the FDA has issued clear information that major brands of jarred peanut butter on grocery shelves are not subject to the recall. But there are hundreds of products affected–so many that the FDA has set up a database to track them all. If you [...]
Part of the problem behind the recent spread of
Salmonella-infected peanut paste products is a disastrously underfunded FDA.
Andrew Pollack at The New York Times reports that biotech company Geron has won approval for its Phase I trial of a hESC-derived therapy, which will treat spinal cord injuries:
Geron’s trial will involve 8 to 10 people with severe spinal cord injuries. The cells will be injected into the spinal cord at the injury site [...]
The United States boasts a huge corps of public-servant scientists devoted to going where the evidence takes them and who, as of Wednesday, will for the first time in years be respected by the highest officials in the land for what they do.
A Food and Drug Administration advisory panel has deemed a drug from a genetically engineered animal to be safe and effective even though the agency has not yet decided what the rules for such approvals should be.
A thumbnail of advances in science that will have long-lasting impacts on science policy—or advances in science policy that we predict will have long-lasting impacts on science.
One out of every four dollars Americans spend goes toward products the safety of which rests in the hands of the Food and Drugs Administration. But as Virginia Cox points out in her chapter on the agency in the forthcoming book
Change for America: A Progressive Blueprint for the 44th President, “Consumers today are understandably skeptical about the safety of their food and medical products, yet the [FDA] is struggling to keep pace with breakthroughs in science, an expanding global market, and years of underfunding.”
Synthetic biology is on the brink of two noteworthy accomplishments: to be able to “streamline” and redesign the genetic material of living organisms to make them operate more efficiently; and to design and assemble entirely new, artificial life forms from scratch. But a lengthy list of potential risks, as well as broad scientific and social concerns, are largely unaddressed.
The Washington rumor mill is buzzing with names of possible science appointees—and there are dozens of major science-related positions to fill. The questions appointees will face are an opportunity for a clear break with past approaches.
Yesterday, the Science Board Subcommittee on Food Contact Applications of BPA released its report on the Food and Drug Adminstration’s draft assessment of bisphenol A, a chemical used to strengthen all manner of plastic containers, the most damaging example being baby bottles. This story has been brewing for months, and the public health bloggers who smelled a regulatory proposal baked with industry-authored research are slamming the FDA.
To the pharmaceutical companies out there pushing spurious claims about their medications with millions in marketing dollars: Stop. Now. And please submit your data to the FDA for review.
Today the FDA released its long-awaited—and in some quarters, long feared—proposed new rules for marketing foods from animals that have been genetically engineered to have particular traits.
Milk and meat from cloned animals could be in the U.S. food supply, and the Food and Drug Administration and U.S. Department of Agriculture can’t detect it, says an FDA official, despite a USDA “voluntary moratorium.” But products from cloned animals may have been in the food supply for a while.
Yesterday, the U.S. Department of Agriculture proposed a rule that cattle too sick to stand should not be turned into hamburgers. The move raises the opportunity to consider broader issues regarding federal food safety structures, which have been under scrutiny since this summer’s outbreak of
salmonella St. Paul, which was eventually traced to imported serrano peppers.
A quick look at the issues making the rounds on the science blogs this week.
Why did it take almost four months after the first report of a Salmonella St. Paul infection for the Food and Drug Administration and Centers for Disease Control to find the grower responsible? Two congressional hearings yesterday and today aimed at understanding why this most recent food safety scare took so long to understand.
With the support of cigarette manufacturer Phillip Morris USA, the House voted Wednesday to approve legislation that would give the Food and Drug Administration the power to regulate tobacco.
The House and Senate agreed yesterday to ban three types of phthalates, chemicals that are common in plastics, perfumes, lotions, and shampoos, and that can disrupt normal hormone function.
In response to recent outbreaks of food-borne illnesses, including salmonella-contaminated tomatoes, the Bush administration has asked Congress to add $275 million to the proposed 2009 budget of $2.4 billion for the Food and Drug Administration. But the patch won’t fix a fractured food safety system.
David Michaels speaks at a Center for American Progress event to discuss his book,
Doubt Is Their Product, explaining the “tricks of the trade” used by cigarette makers, drug companies, and climate change deniers to delay regulation that would make Americans safer.
As food worries grow, so does the appeal of a single federal Food Safety Administration to deliver effective oversight of what America eats.
On Tuesday, the House Subcommittee on Oversight and Investigations held a hearing on a contaminant in blood thinner heparin that caused 81 deaths. Federal regulators now believe the contamination was deliberate, identifying a Chinese subsidiary of Scientific Protein Laboratories. It is no longer realistic to expect the FDA to make informed decisions if it does not have the resources to undertake foreign inspections.
The latest news on industry obfuscation of scientific research and government complicity is that the Food and Drug Administration relied on studies funded by trade groups in decisions on an unsafe compound in common plastic products.
In Congress there is astonishingly shortsighted opposition to the obvious need for the Food and Drug Administration to police the tobacco industry.
Allegations of professional baseball players abusing human growth hormone have raised the profile of this heavily regulated substance. The House on Oversight and Government Reform held a hearing yesterday to sift through misinformation on HGH and get the scientific facts.
India ramps up science and engineering education; the European Commission has more questions for Microsoft; the International Linear Collider may end up in Japan; Supreme Court rules that terminally ill patients do not have a constitutional right to developmental drugs; FCC could have trouble selling all its wireless licenses.
An FDA study says that milk and meat from cloned animals is safe for human consumption. The news breaks close on the heels of reports that the E.U.’s European Food Safety Authority released similar findings that food from cloned livestock is “very unlikely” to harm consumers.
Three young women scientists make history; arguments over the impact of climate change on global health; how not to get funding from the NSF; John Marburger talks with the National Journal; conflicts of interest at the FDA; the ailing Discovery Corps Fellowship program; and what is Evo-Devo?
The U.S. Food and Drug Administration is so underfunded and understaffed that it is putting consumers at risk to unsafe foods and drugs, according to a report, “FDA Science and Mission at Risk,” released by an advisory panel to the government agency on November 30th.
The University of Virginia is being accused of encouraging doctors to prescribe Johnson & Johnson’s anti-seizure and migraine drug Topamax “off-label” to treat alcoholism. But is the medicine safe for treating alcoholics without FDA approval?
