All Features
Kimberly Egan
What do China, Maine, Connecticut, Chipotle, and Whole Foods have in common? They all think you have a right to know whether the food you are eating contains any genetically modified organisms, known as GMOs.
I like that. Why do I care? Because the genes in GMO plants have been altered in a…
Michael Causey
The Internet giveth and the Internet taketh away. For years, we’ve been hearing about the benefits online tools will bring to the medical industry, especially at hospitals and physicians’ offices. Many of those promises have come true, and it’s been a benefit for patients and industry.
But that…
John Roth
In an earlier article, I explained how the Food and Drug Administration’s (FDA) Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high: $1.4…
Gallup
If you’re a hospital leader, the safety of your patients and your employees might be keeping you up at night. That’s because senior management is accountable for creating and maintaining a safe environment for hospital staff and patients. You’re right to be concerned. Research has shown that the…
Michael Causey
The shell game called the federal budget added another nut recently as media reports revealed that during the last 20 years, approximately $1 billion in fees paid by patent applicants has been diverted from its proper use at the United States Patent Office (USPTO).
Critics argue that, as a self-…
James Andrews
T
ake a moment to consider some of the foods we find at the supermarket: eggs, tomatoes, coffee — maybe even chocolate chip peppermint brownie ice cream. Now, try to imagine all the steps and processes that the food went through to get all the way to those shelves.
Although the ice cream likely…
Michael Causey
The latest batch of Food and Drug Administration (FDA) inspection letters noting objectionable conditions, aka 483s, has a decidedly international flair: Italy, Japan, and Canada had the pleasure of hosting FDA inspectors in recent months. Three firms were found wanting by the agency in a number…
Quality Digest
On March 28, 2013, the world lost a person whom many consider to be a major contributor to the world of industrial statistics: George E. P. Box. Relatively unknown outside the world of statistics, Box was certainly very well known by those who have studied or practiced industrial statistics.
His…
Michael Causey
The giant sequoia trees on the Pacific Coast are breathtaking. Majestic and seemingly indestructible, they stand tall as a reminder that slow and steady sometimes does win the race. But what’s great in a forest isn’t always so great elsewhere.
Let’s push the metaphor a bit more, and say there’s…
Margaret A. Hamburg
The deadly outbreak, in October 2012, of fungal meningitis associated with a compounded medication was a horrible tragedy. I’ve asked myself many times if and how it could have been prevented. I speak for everyone at the FDA when I say that our hearts go out to the many victims, including those…
A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he is having a heart attack—is in my opinion an extremely smart phone. That is just one example of how mobile medical applications are transforming healthcare.
As…
Michael Causey
A prominent politician goes before his constituents during a tough reelection campaign. He’s introduced by the local mayor, and strides to the stage, waving and smiling to enthusiastic applause.
“It’s great to be here with you tonight. I love this great state of [fill in the blank]. Erica and I…
American Customer Satisfaction Index ACSI
The national customer satisfaction benchmark improved during the fourth quarter of 2012, rising 0.5 percent to an American Customer Satisfaction Index (ACSI) score of 76.3 on a scale of 0 to 100. Although most of the gain is due to improvements in the public sector—satisfaction rose for both…
Kimberly Egan
Nutrition labels have been much in the news lately, presumably because we have once again won the fattest nation contest. The Food and Drug Administration (FDA) and various nutrition researchers have all put out some thought-provoking information for us to ponder.
The problems
First, people don’t…
Michael Causey
Turns out that some paranoid people have a reason to, well, be paranoid. Researchers from the London Business School issued a report last year finding that many people at work who thought they were being talked about were probably right.
Maybe some in the medical device industry can be forgiven…
Harry Hertz
According to a recent PBS report based on information from the Organization for Economic Co-operation and Development (OECD), the United States’ healtcare expenditures are 2.5 times greater than that of the most developed nations around the world. Depending on which report you read, our healthcare…
IntraStage
The first production Model T auto in 1908 ushered in a new era of transportation by shrinking dramatically the time it took for people to move from place to place. Like the Model T, communication technologies such as email, mobile phones, and the Internet are dramatically shrinking the time for…
Matthew E. May
Recently I had a conversation with a friend who was upset about some directional shifts and a looming job shuffle within his company. As I listened to the lament, I recognized that the changes he described focused on the symptoms of the issue. All of his reactions and proposed courses of action…
Kimberly Egan
On Jan. 4, 2013, the Food and Drug Administration (FDA) took the first step in its history to regulate produce farmers. The agency issued a 547-page proposed rule that spends a lot of time reducing everything humanity has learned about plants since agriculture emerged in the Fertile Crescent 10,…
Jim Frost
This flu season has been worse than normal. The Centers for Disease Control and Prevention (CDC) data show that the flu has struck early and hard. Influenza cases shot up during December rather than the more usual January or February, and 47 states report widespread influenza cases.
I get a flu…
Tamar June
A Jan. 11, 2013, email sent by Michael Fauntleroy, program manager for the Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG), the agencywide solution for accepting electronic regulatory submissions, warns those using the WebTrader for electronic submissions to delete their…
FDA
Last December, Sunland Inc. entered into a court-ordered agreement imposing requirements that must be complied with if the company is to operate. This consent decree follows the Food and Drug Administration’s (FDA) suspension of Sunland’s food facility registration in November 2012. The suspension…
Davis Balestracci
The 24th Institute for Healthcare Improvement (IHI) Annual Forum took place on Dec. 9–12, 2012. It is probably the leading health care improvement event in the world. I have presented there for 20 consecutive years and watched it evolve from barely 1,000 attendees to well over 5,000. What’s changed…
Patrick Stone
It’s clear that the Food and Drug Administration (FDA) should have more compounding pharmacy oversight, but how long will it take them to make other important decisions on public health?
The recent news is troubling.
For example, a shipment of tainted steroid from a Massachusetts-based compounding…
Margaret A. Hamburg
Every year, millions of products regulated by the Food and Drug Administration (FDA) flood into the United States from 150 countries. Ensuring these products are safe and effective can be daunting task. It was heartening for me to sign two cooperative arrangements with some of our international…