BIOETHICS

The Stem Cell Hype Machine

The debate over embryonic stem cell research has been wrought with hype. Here are the top five over-hyped claims made by critics, and why they are wrong.

LIFE SCIENCES

Drug Regulation in all the Wrong Places

The FDA’s myopic focus on early-stage testing and lack of emphasis on phase four human clinical trials has led to many safety-related drug recalls in recent years, meriting a reexamination of our regulatory system.

LIFE SCIENCES

One Small Step for Embryonic Stem Cells

The Food and Drug Administration approves the first clinical trial for embryonic stem cell treatment in patients with recent spinal cord injuries—creating a much needed regulatory pathway.

FDA Intervention Shelves Plan for Drugstore Genome Tests

Earlier this week, Pathway Genomics was poised to begin selling its Insight genetic test kit at 6,000 Walgreens pharmacies nationwide, but then the Food and Drug Administration put its foot down. On May 10, just after Walgreens and Pathway made [...]

FOOD SAFETY

To Our Health!

Deficiencies in the regulation of the American food supply constitute the most serious and persistent gap in American consumer protection. Congress must seize the opportunity to fix the problem.

NIH and FDA Aim to Retool Regulatory Science

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 [...]

FOOD SAFETY

Battling Back Bacteria

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.

FDA Looks to Open Up the Medicine Cabinet

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 Real Problem of Fake Medications

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 [...]

So What Does the FDA Do, Anyway?

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, [...]

Would You Like Some Data With Your Safer Food?

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 [...]

Top Brass on FDA as “Public Health Agency”

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 [...]

Keeping Americans Safe from Faulty Medical Devices

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 [...]

Administration to Split FDA?

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 [...]

WEISS'S NOTEBOOK

Snack Shelf Epidemic

The peanut product recalls continue, revealing more cracks up and down the food safety system. And people keep getting sick.

WEISS'S NOTEBOOK

The Big Business of Nano Litigation

A recent conference examining the legal protections corporations are taking to defend themselves in the event their products turn toxic should raise regulatory questions.

FDA Approves First Drug Made in a Mammal

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 [...]

FDA Embraces Personalized Medicine

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 [...]

Questions for Peanut Butter Investigators

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 [...]

Peanut Butter Problems

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 [...]