Tag Archives: united states food and drug administration

Conflicts abound for private food inspectors

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The Washington Post‘s Lena H. Sun has gathered, in one story, a laundry list of all the shortcomings, loopholes and conflicts of interest plaguing an American food inspection system so flawed that foodborne disease outbreaks are routinely caused by facilities with “superior” safety ratings (See Wright County Egg and the Peanut Corporation of America).

Here, I’ve cherry-picked Sun’s basic points. They echo much of what we’ve heard from previous food-safety investigations, despite the fact that each story always seems to end with the FDA pledging to reform the system. Her first observation is also the most fundamental, and will be familiar to anyone following the role of independent credit rating agencies in the financial crisis.

“… auditors are typically paid by the companies they are inspecting, creating a conflict of interest for inspectors who might fear they will lose business if they don’t give high ratings.”

“Food companies often choose the cheapest auditors to minimize the added expense of inspections, which range from about $1,000 to more than $25,000.”

“… foodmakers can prepare for audits because they often know when inspectors will show up.”

“… auditors have a range of experience and qualifications, from recent college graduates to retired food industry veterans. They sometimes walk through a plant, ticking off a checklist to produce a score, Samadpour said. Basic inspections do not typically include microbial sampling for bacteria.”

“The FDA has the authority but not the resources to routinely inspect the estimated 150,000 food-processing plants in the United States or the 250,000 facilities abroad that supply U.S. consumers.”

FDA steps up regulation of infusion pumps (#AHCJ2010)

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Infusion pumps, a widely varied class of devices which typically mete out precise, time-delayed doses through IVs and related means, have been associated with 56,000 adverse events and more than 500 deaths in the past five years, Dr. Jeffrey Shuren told journalists assembled at Health Journalism 2010 this morning. Shuren is head of the FDA’s devices center. The malfunctions are often caused by hardware and software issues, and can lead to overdoses and other harmful events.

pumpPhoto by Felix42 via Flickr.

NPR health blogger Scott Hensley, who was there for Shuren’s presentation, wrote that the FDA appears determined to take action to improve the pumps, which are almost ubiquitous in American hospitals.

The “widespread problems we are seeing warrant” prompt action, Dr. Jeffrey Shuren, head of the FDA’s devices center, told a meeting of the Association of Health Care Journalists in Chicago.

The agency will require design improvements, more thorough testing, and inspections of the infusion pump makers’ facilities before the devices are allowed on the market.

Schneider: FDA lacks resources to keep food safe

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Writing for AOL News (and his blog, Cold Truth) Andrew Schneider writes that the hydrolyzed vegetable protein recall reminds us that, no matter what was said in the wake of last year’s peanut butter recall, the FDA still doesn’t have the ability to pay close attention to source foods that are destined to end up in hundreds of different products.

In this most recent case, it was a test by a supplier, not an FDA representative, that caught the contaminated additive.

The FDA conducted an investigation at the company’s Las Vegas facility after a food producer that bought the flavoring from Basic Food Flavors notified federal agents that it had found Salmonella Tennessee in the vegetable protein.

In answer to the criticism about its actions during the peanut episode, FDA officials said they have no way knowing to whom suppliers sell their food products, what those products are and where they’re sold. The FDA says it doesn’t have the personnel or the needed regulations to handle the millions of shipments made within the food industry every week.

But what was seen with the dangerous peanuts, and what we’re beginning to see with the flavoring agent, is that producers of end products — those items that actually reach store and warehouse shelves — are declaring their own voluntary recalls.

FDA to regulate health information technology?

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

Fred Schulte and Emma Schwartz, the Huffington Post Investigative Fund duo who have made it their business to stay in front of all stories related to the federal push for the adoption of health information technology, now look at the possibility of federal regulation of health IT.

Schulte and Schwartz write that “In the past two years, the agency has received reports of six patient deaths and several dozen injuries linked to malfunctions in the systems,” and officials say those voluntary reports represent just the tip of the iceberg. In case you’re interested, here are the transcripts from the relevant government hearing.

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Photo by brianjmatis via Flickr.

… digital medical systems are not risk-free. Over the past two years, the FDA’s voluntary notification system logged a total of 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and the six deaths. Among other things the systems have mixed up patients, put test results in the wrong person’s file and lost vital medical information.

Schulte and Scwartz summarize the three possible regulatory approaches outlined by officials:

  • Option 1: FDA requires HIT makers to register, submit safety reports and correct problems.
  • Option 2: FDA requires HIT makers to report safety concerns and sets minimum quality guidelines.
  • Option 3: FDA makes HIT “subject to the broader regulatory actions that new medical products must face before they ever reach the market.”

Many manufacturers argue that such regulation could be counterproductive.

The manufacturers of the systems generally have opposed regulation by the FDA, arguing in part that imposing strict controls would slow down the government’s campaign to spur widespread adoption of the technology.

Regulation will not necessarily create a “safer” electronic medical record “and might actually limit innovation and responsiveness when it is needed most,” Carl Dvorak, executive vice president of Epic Systems Corporation, a Wisconsin-based company that builds the systems mainly for hospitals and large medical practices, said in his prepared testimony for Thursday’s hearing. The hearing is being held by an advisory group created by the stimulus law.

Government Health IT also is following the issue and points to some problems the Veterans Health Administration has run into and how it dealt with the lapses.

FDA warns against promoting unapproved drugs

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The New York Times‘ Natasha Singer looked into the FDA’s recent warning of prominent cosmetic doctor Leslie Baumann (bio) for the promotion of an unapproved drug, based on comments she made about Botox-like Dysport (she was an investigator in a trial of the treatment) in outlets such as Allure, Elle and the Today Show. Singer also considered the chilling effect this warning might have on other clinical investigators upon which the media has traditionally relied.

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Dr. Leslie Baumann, from skintypesolutions.com

Now, some industry experts say the F.D.A. warning may curb the media enthusiasm of certain cosmetic doctors who until now have provided scoops about coming medical products — or have talked up the latest unapproved cosmetic uses for drugs and devices that the agency had approved only for other purposes.

“It’s a wake-up call,” said Nancy Behrman, owner of Behrman Communications, a public relations firm in Manhattan. Her firm has represented cosmetic medical companies as well as doctors. “The whole business has spiraled out of control, and we need to step back and slow it down.”

FDA representatives say that there’s a line between scientific discussion and drug promotion, and that investigators are welcome to talk to the media as long as they don’t cross it.

Thomas W. Abrams, director of the agency’s Division of Drug Marketing, Advertising and Communications, said that investigators were free to have scientific conversations about investigational drugs with their peers and with journalists. But an investigator should not promote any unapproved prescription drug — or an unapproved use of an already approved drug — as being safe or effective if the agency has not yet deemed it to be so, he said.

Singer also talks to another of the media’s favorite doctors, dermatologist Fredric S. Brandt, who said that, in future discussions with media he would take care to offer only scientific facts on unapproved drugs, and leave his opinions and recommendations out of the discussion.

FDA launches transparency site with help of tongue depressor

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

In the first step of a planned three-part transparency initiative, the U.S. Food and Drug Administration has rolled out FDA Basics, a tidy little Web portal aimed at helping the public understand exactly what the agency does. And that, according to the page’s centerpiece, is regulate tongue depressors. The goofiness of the example aside, the FDA does use the depressors to make a pretty solid point about device regulation, as you can see below.

fda1

All in all, the FDA manages to pack enough information into the site to educate and even intimidate curious consumers. In addition to the bit about devices, it has dedicated pages to each of its core regulatory missions, stuff like dietary supplements and cosmetics. It also has announced a series of topic-specific Webinars and given the site a hearty sprinkling of suggestion and question submission boxes, as well as contact information.

To announce the site the FDA hosted a Webinar on Tuesday to teach bloggers about the Basics site; a promised recording of the session has yet to materialize.

(Hat tip to Medical Marketing and Media)