All Features
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…
Matthew E. May
I remember when I first discovered the work of Mark Graban. The year was 2008, and I was preparing to speak to the Massachusetts Hospital Association, an audience of about 400 hospital CEOs and administrators. They wanted me to tie my work with Toyota to healthcare, which I had no firsthand…
Jay Arthur—The KnowWare Man
The United States spends $2.5 trillion for healthcare. Healthcare spending is expected to reach $4.5 trillion by the end of the decade. With Obamacare becoming a reality, we need to find a way cut the cost of healthcare to help pay for these increasing costs. The Institute of Medicine (IOM)…
University of Michigan
At hospital shift changes, doctors and nurses exchange crucial information about the patients they’re handing over—or at least they strive to. In reality, they might not spend enough time talking about the toughest cases, according to a study led by the University of Michigan.
These quick but…
Johns Hopkins University
Computational medicine, a fast-growing method of using computer models and sophisticated software to figure out how disease develops—and how to thwart it—has begun to leap off the drawing board and land in the hands of doctors who treat patients for heart ailments, cancer, and other illnesses.…
Susan Kelly
I’m a relative newcomer to government work, having joined the Food and Drug Administration (FDA) about 18 months ago after decades of being a journalist. My job is to assign, write, and edit FDA consumer updates, which are news stories posted on www.fda.gov designed to give consumers important…
Gallup
The rising cost of healthcare in the United States coupled with the absence of return on investment for Americans’ health is an important concern for many leaders across the country. And as many health systems adopt new strategies to reduce patient readmission rates and improve Hospital Consumer…
Patrick Stone
Compounding pharmacies, where the creation of a particular pharmaceutical product to fit the unique needs of a patient is done, have enjoyed the protection of their state pharmacy board, or they don’t distribute outside their home state (no interstate sales). This means that compounding pharmacies…
Michael Causey
There are two things right now that get relatively bipartisan support in Washington, D.C. The first is that a major league baseball team in D.C. won a pennant for the first time since we stopped huddling around our radios for entertainment. [Editor’s note: The Nationals lost in the first round of…