Friday, March 30, 2012

FDA: Lovely Lilies and Curious Cats: A Dangerous Combination

With Easter approaching, please watch out for your family cats . . .

FDA Animal Health Literacy and Lovely Lilies and Curious Cats: A Dangerous Combination:

"It’s also important to remember that while lilies, a common household plant, are lovely to see and smell, they are still a safety threat for our cats. The entire lily plant (leaf, pollen, and flower) is considered to be toxic for cats. If you have lilies in your home this Easter, make sure that your cat doesn’t eat any part of the plants"

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Tuesday, March 27, 2012

FDA Targets ‘Cosmeceuticals’ Straddling Regulatory Lines

The FDA can barely manage pharmaceuticals, biotech, and medical devices. The last straw will be foods, dietary supplements, and cosmeceuticals . . .

FDA Targets ‘Cosmeceuticals’ Straddling Regulatory Lines - Businessweek:

"Wrinkle creams with retinol and a growing crop of beauty treatments that are partly pharmaceutical may need to be regulated as drugs, the top U.S. official overseeing the cosmetics industry said.

The industry calls them “cosmeceuticals,” a term that doesn’t exist in regulation,Michael Landa, director of the Food and Drug Administration’s Center for Food Safety and Applied Nutrition, said in testimony prepared for a House subcommittee hearing today. The claims companies make that the products contain active ingredients may classify them as drugs, he said."

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Sunday, March 25, 2012

The skinny on FDA regulation of dietary supplements

Spirulina (dietary supplement) tablets are mad...
Spirulina (dietary supplement) tablets are made from cyanobacteria genus Arthrospira. (Photo credit: Wikipedia)
This is a quick, concise overview that contrasts how the FDA views and regulates drugs versus dietary supplements.  The author says . . .

The skinny on FDA regulation of dietary supplements | Fox News:

"Recently I spoke with representatives from the Food and Drug Administration (FDA), and it occurred that there is some confusion about what “regulation” by the FDA means when it comes to dietary supplements.  The term “regulate” has various meanings.

In a general sense, dietary supplements fall under the purview of the FDA – where there are regulations that pertain to labeling and “claims.”  However, when it comes to the measurement of safety and effectiveness – as prescription drugs must do – it is not the same.  The FDA does not ensure potency, purity or biologic activity of the ingredients in dietary supplements.  There is no registration or clearance by the FDA before a dietary supplement goes on the market."

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Saturday, March 24, 2012

Court orders FDA action on antibiotic use on farms

Court orders FDA action on antibiotic use on farms - USATODAY.com:

"In a ruling handed down Thursday, Judge Theodore Katz said the FDA must begin steps to withdraw approval of the two antibiotics for routine use in animals, siding with four consumer safety groups that brought a lawsuit against the agency.

"Today we take a long overdue step toward ensuring that we preserve these lifesaving medicines for those who need them most — people," said Avinash Kar, attorney for the Natural Resources Defense Council.
The court ruling will not immediately halt the use of antibiotics on farms. The FDA must first give drug companies a chance to respond and schedule a public hearing."

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For more information, visit:
FDA - Animal and Veterinary - Antimicrobial Resistance

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Thursday, March 22, 2012

Aspirin May Help Prevent Certain Kinds of Cancer (video)

This is a nice interview and discussion triggered by the latest published findings in the medical journal, Lancet.

The findings strike a chord with me because about 20 years ago, I started taking a baby aspirin every day. Back then there was sparse information available, and I started in hopes of preventing gastrointestinal cancers that my parents succumbed to.

 

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Wednesday, March 21, 2012

PharmaGossip: Martha Rosenberg: The Big Pharma Bubble

You've got to read this.  Very provocative and deeply disturbing. Be sure to read the entire article.

PharmaGossip: Martha Rosenberg: The Big Pharma Bubble | Scoop News:

"It is no consolation to the roughly one out of 600 families who lost their homes in the U.S. but Wall Street made a lot of money slicing and dicing mortgages it knew would implode, while hiding risks. Financial giants, like AIG, are still buzzing along and neither penalties or new laws will prevent a future crash, say financial analysts, because the risky business models have not really changed. In fact, occlusive business models responsible for the previous Internet bubble in 2000 and for which CEOs are still in prison may soon be legal again under the U.S.' pending JOBS Act. Thanks for that.

A similar Big Pharma bubble, leavened with risky blockbuster drugs that also blew up, is now bursting. Almost 20,000 jobs have vanished at AstraZeneca, Novartis and Pfizer in the last 12 months alone. AstraZeneca has scrapped 21,600 more jobs since 2007."

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Select e-Learning That Is Pure, Safe and Effective

Watch out for PowerPoint slides full of nothing but text. Buy a book if that's what you want!

SkillsPlus International Info:

"Selecting an online e-Learning course is really rather simple.

  1. Identify the course you really need. An Internet search is a great way to learn what is offered.
  2. If they boast about being the least expensive, remember that you get what you pay for. The best business advice I ever got from one of my accountants was, never purchase cheap.
  3. Compare the objectives of each course versus your requirements.
  4. Call the vendor and ask if there is a handout. If not, begin to wonder if the vendor is afraid that the lesson content may not be accurate and not stand up to a critical review.
  5. Ask to see a preview of the course. If they do not offer a free preview, question what they are hiding. Be concerned that you will be paying a lot of money to read a book on your computer screen.
Demand more!"

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Tuesday, March 20, 2012

Public wants strong medical device oversight

Poll: Public wants strong medical device oversight:

" . . . 71 percent of the poll respondents said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.

Ninety-four percent of poll respondents indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.

Similarly, 95 percent of respondents said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law."

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Sunday, March 18, 2012

What Stresses Some Pharma Employees The Most

An interesting report of stresses on pharma, and the stresses that pharma employees experience.

What Stresses Some Pharma Employees The Most // Pharmalot:

" . . . when asked about the biggest changes at work, nearly half say that on-the-job conditions are worse - 49.5 percent cited increased workloads due to staff cuts and nearly 49 percent report a new team or organizational structure. Nearly 18 percent say they are burnt out most of the time and 55.4 percent are burnt out some of the time. Almost 39 percent complain this is a real issue that is hurting productivity. And 45 percent say they have to pitch in to do things outside their domain.
Interestingly, when asked how the economy has hurt their employer recently, the responses indicated some improvement - nearly 38 percent report a hiring freeze, down from nearly 50 percent the year before. Similarly, 41 percent named layoffs, compared with 53 percent in the prior year. Salary freezes were cited by 19.4 percent versus 29.2 percent, and 24.7 percent pointed to outsourcing, down from 33.8 percent."

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Tuesday, March 13, 2012

Using Video In The Classroom - Free GMP and QSR Training Tip

The image shows a comparison in size of a Dixo...
Image via Wikipedia
Using Video In The Classroom - Free GMP and QSR Training Tip | SkillsPlus International Info:
  1. "Tell the class what they are going to see and why you want them to see it. 
  2. Give the class an assignment to perform during and immediately after the video or DVD has ended. The assignment can be as simple as, "During this DVD write down as many things you did not know prior to watching this DVD." 
  3. Now it's time to turn on the DVD. See our list of SkillsPlus Intl Inc. movies and interactive CBTs 
  4. After the DVD is over, follow up on what the class has learned. Using the round robin technique, chart everybody's responses. As an instructor, elaborate on the class response as appropriate."
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Sunday, March 11, 2012

FDA rethinking food inspections

English: Upton Sinclair early in his career
Image via Wikipedia
I wonder what Upton Sinclair would say about the state of current affairs.

FDA rethinking food inspections - DailyHerald.com:

"The surge in imports has also increased the chances of contamination in foods regulated by the FDA. About 80 percent of seafood, 50 percent of fresh fruits and 20 percent of fresh vegetables are imported.

Despite the mounting threats, the FDA and its contractors inspected only 6 percent of the 421,000 domestic and foreign facilities under its watch in 2010, according to the most recent figures. Inspections account for the full-time work of just 1,000 employees. But if a site is linked to an outbreak of illness, inspectors and FDA scientists descend on it, sometimes staying put for weeks.

Under the food-safety bill enacted last year, food companies must adopt plans to spot and prevent hazards. The law also mandates more frequent inspections. For instance, plants that produce or process high-risk foods, including foods connected to previous outbreaks, must be inspected by 2015 and every three years thereafter."

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Knock, Knock, FDA Calling

This is a nice article with a nutritional supplement twist to it.

Knock, Knock, FDA Calling - Slowtwitch.com:

"In the United States, the Food and Drug Administration (FDA) is responsible for protecting and promoting public health with ultimate oversight of food and drugs, and of particular interest for this article, the nutritional supplement industry. Their regulatory control covers two main areas: product safety and accurate product labeling. This article summarizes some of what goes on behind the scenes to keep consumer products safer."
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