Posts Tagged ‘ FDA ’

If the FDA Wore a Uniform

February 25th, 2010. By Hunter West

You gotta love the good ol’ FDA (US Food and Drug Administration) for its renewed stance on oversight on things such as drug advertising. Four months into the Obama Administration, the FDA gets a new leader—Margaret Gamburg—and all of a sudden things start happening.

Among other crackings of the whip, the FDA issued draft guidelines designed to clarify what is appropriate in drug ads. You know, things like upping the music volume when all those nasty, ‘adverse reaction’ bits appear. Or the use of distracting images and visuals to take the focus away from what you are hearing. 

The renewed focus on what consumers are seeing in medicinal TV ads—which seem to take center sponsor stage on the major network television newscasts each night—stems from a few well-placed cat calls from John Dingell and Bart Stupak. Back in 2008 the two congressmen openly questioned if drug advertising properly presented product benefits and risks. 

Among other complaints, Stupak criticized Pfizer for using the inventor of an artificial heart, Robert Read the rest of this entry »

Tags: Dingell, DUI, FDA, Gamburg, OxyContin, Stupak, Trasylol
Posted in Drugs/Medical | 1 Comment »

“This Statement has not been Evaluated by the FDA”

February 5th, 2010. By Kristine B

And until something changes, it ain’t gonna be.

This week, a study was released suggesting that the combination of herbal remedies and heart medications can be dangerous for patients. According to the study, patients who use popular herbal remedies—including ginko biloba, St. John’s wort and Echinacea—along with heart medications are at an increased risk of serious heart rhythm problems, higher blood pressure and bleeding. Serious stuff.

If you’ve ever wondered how the herbal supplement industry is regulated, read on as Pleading Ignorance dives into the regulation of dietary supplements.

What is a Dietary Supplement?

Good question. The phrase “dietary supplement” gets tossed around a lot. It’s a vitamin. It’s a weight loss miracle. It’s a muscle-builder. Or the secret to an improved sex life. “Dietary Supplement” means a lot of things. But the FDA, in accordance with the Dietary Supplement Health and Education Act (DSHEA) of 1994, defines “dietary supplement” as a product taken by the mouth that contains dietary ingredients that are intended to supplement the diet. Sounds like a definition that basically says a lot of nothing–except that the supplement needs to be taken orally. Ok, so what’s a dietary ingredient? According to the FDA site, a dietary ingredient is a:

• vitamin
• mineral
• herb or other botanical
• amino acid
• dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands)
• concentrate, metabolite, constituent or extract

Makes sense, but that date—1994—is important… Read the rest of this entry »

Tags: dietary supplements, FDA, herbal supplements, Pleading Ignorance
Posted in Pleading Ignorance | 2 Comments »

Having a Baby? Get to Know the FDA Drug Classifications

January 27th, 2010. By Kristine B

Navigating the complex web of drug categories can be complex and overwhelming. Add to that the pregnancy categories and it can be tough to determine just which drugs a pregnant woman should and shouldn’t take. This week, Pleading Ignorance looks at the different FDA pregnancy categories. 

How Does the FDA Classify Drugs for Pregnancy? 

Basically, the categories are based on studies, including animal studies, human studies and/or post-marketing data (reports that have come in after a drug is released on the market). Information taken from those studies—including adverse reactions and potential side effects—is then used to put the drug into a pregnancy category. 

Now, although the categories may seem straight-forward (they are all letters) they aren’t necessarily that simple. Some drugs might have a higher impact on the fetus depending on the point at which they’re taken during pregnancy. Other drugs might have a higher risk of abnormality depending on the dosage taken. When it comes to taking medications while pregnant it’s important for pregnant women to discuss their options with their doctor to determine if the benefits outweigh the risks. 

Also, keep in mind that as increased post-marketing data for a drug becomes available, the FDA can change a drug’s pregnancy category. So, a drug may start out in Category B, for example, but be moved to a Category C if there is enough evidence of an increase in risk after the drug is approved for use. 

FDA Drug Classifications for Pregnancy

So, here’s how it breaks down: 

Category A: Means that controlled studies have found no risk to the fetus when the mother takes the medication during any trimester of pregnancy. 

Category B: Means that controlled studies in pregnant women have not shown an increased risk of fetal abnormalities, although some adverse findings have occurred in animals. It can also mean that there are no adequate human studies but animal studies show no fetal risk. There is a remote possibility of fetal harm. 

Category C: Means that there is a risk. Either there are not enough adequate human studies, but animal studies have shown a risk or there are not adequate animal studies. There is a chance of fetal harm but benefits may outweigh the risks.  Read the rest of this entry »

Tags: FDA, FDA Drug Classification, Pleading Ignorance
Posted in Pleading Ignorance | No Comments »

Pharmaceutical Companies Want YOU to Want Them

January 21st, 2010. By Kristine B

Last week, we saw how pharmaceutical companies target medical professionals in their marketing. This week, Pleading Ignorance looks at how they target you, the patient. 

When you are targeted in an advertisement or marketing plan for pharmaceuticals, that’s called direct-to-consumer advertising (DTCA). Now, it may seem a bit silly for pharmaceutical companies to target patients—after all, the patient has to rely on the doctor to first diagnose a health problem and then prescribe the medication. 

But, if you notice, the tv ads encourage you to “talk to your doctor about [insert name of drug here].” They expect that you will see the ad, identify with the list of symptoms or the general health issue mentioned, and go straight to the doctor, demanding you get a prescription for that particular drug. 

So, if consumers are being given the drugs they want and need, is there really a problem with DTCA? 

According to the National Conference of State Legislatures (NCSL,ncsl.org), there are concerns about DTCA advertising. 

One concern is that the costs of drugs are “soaring” (their word) and becoming more and more difficult for people Read the rest of this entry »

Tags: Drug Marketing, FDA, Pharmaceutical Marketing, Pleading Ignorance
Posted in Pleading Ignorance | 2 Comments »

FDA Taking Baby Steps on BPA

January 21st, 2010. By Hunter West

Last week the US Food and Drug Administration did an about-face on its stance with regard to bisphenol-A (BPA), saying Friday that it has had “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children,” and would join other federal health agencies in studying the chemical in both animals and humans. 

This, in contrast to its report of 2008, when the agency deemed the chemical safe. 

Not that the FDA is saying that BPA is unsafe. Far from it. “If we thought it was unsafe, we would be taking strong regulatory action,” said Dr. Joshua Sharfstein, the principal deputy commissioner of the drug agency, at a news briefing late last week. 

However, it is a hint—baby steps here—that the FDA is taking a harder line on issues than it appeared to take previous to the Obama Administration. Needless to say safety advocates are buoyed by the change of position, short of being overjoyed given their entrenched view that the FDA has not gone far enough. 

The chemical industry from whence the BPA originates, is also not happy with the news. 

Hardly surprising, as both camps line up and defend their respective positions—the chemical industry saying that the FDA’s concerns are unfounded, while the safety advocates say the FDA hasn’t gone far enough. Then there’s the FDA, trying to come up in the middle and be fair to everybody. 

But at least they’re looking. Rather than remain cocooned in a kind of Pleasantville (the movie, with apologies to any real ‘Pleasantvilles’ out there), outfitted with blinders and assuming that everybody, everywhere will be doing Read the rest of this entry »

Tags: BPA, FDA
Posted in Personal Injury | No Comments »