Posts Tagged ‘ FDA ’

What the Heck Does “Off-Label” Mean, Anyway?

January 7th, 2010. By Kristine B

One of the phrases we at LawyersandSettlements.com see frequently is “prescribed for off-label uses.” In fact, we see it a lot. But, we realized that not everyone understands what “off-label uses” actually means, or what its implications are. So, this week’s Pleading Ignorance examines the off-label use of drugs. (I promise this won’t be too painful). 

When a drug is approved by the FDA it’s approved for specific circumstances (meaning, for specific health problems) and, often, for specific people (usually defined by an age range, e.g. adults). That’s because the drug has been tested and shown to be beneficial in treating those health problems in that group of people. 

When a drug is prescribed for off-label use, the drug is being used either for a condition that it was not approved to treat or for a person outside the group listed in the prescribing information or both. 

According to a report at USA Today (11/25/08), a study published in Pharmacotherapy listed 14 drugs that should be studied further regarding their off-label use. Those drugs include Seroquel, an antipsychotic medication that is approved to treat schizophrenia and short-term manic or depressive episodes in bipolar disorder. However, according to researchers, in three out of four cases, the drug has been used off-label, for maintenance therapy of bipolar disorder. Other drugs included on the list, as cited at The Wall Street Journal blog (11/25/08) were Coumadin, Lexapro, Risperdal and Singulair. 

It’s not illegal to prescribe drugs for off-label uses. Doctors are allowed to prescribe an FDA- Read the rest of this entry »

Tags: Drugs, FDA, Off-label, Pleading Ignorance
Posted in Pleading Ignorance | 2 Comments »

Put the FDA in Charge of Homeopathic Products

December 3rd, 2009. By Hunter West

The Zicam issue brings to the fore yet another issue involving the mandate of the US Food and Drug Administration (FDA), the federal health regulator that has jurisdiction over medical devices and medical drugs—and food. A wieldy mandate indeed and one that, due to funding and staffing issues, the agency has been hard-pressed to undertake effectively. 

That said, naturopathic products, natural-health potions and homeopathic elixirs do not fall under the FDA’s regulatory mandate for approval. 

Given the growing popularity of homeopathic products, the FDA’s mandate should be expanded. 

“Many of our clients believed the FDA had evaluated Zicam before it reached the market,” said lawyer Robert Gordon, a partner with the New York law firm Weitz & Luxenberg. “In fact, Zicam products were not regulated or approved by the FDA because they were listed as homeopathic treatments that use natural ingredients. Mounting evidence from the scientific community is proving Zicam with zinc should never have been sold. Some trusting users are now paying a price with their health.”

The status quo only confuses the public. To be fair, nowhere on the labels for products such as Zicam does it say that the product carries FDA approval. And yet, when there is a problem with a product—homeopathic or otherwise—which agency undertakes the issue of the health alert?

The FDA. The latter is also involved in the negotiation and co-ordination of voluntary product recalls—as it was for Zicam—for products the FDA was not required to approve. That, together with the blurring of the lines between what is medicinal and what isn’t, leaves Joe Q. Public at a loss to explain just who is running the show.

The same holds true for dietary supplements and other weight-loss remedies that use natural ingredients. If it’s homeopathic, then a product does not have to satisfy the FDA before it goes to market.

But here’s the rub: various medicinal ingredients, either on their own or in concert with other ingredients, can elicit side effects and other dangerous risks. Hence the requisite testing required of the manufacturers, with the subsequent vetting through the FDA before the product is approved for sale.

However, just because an ingredient is listed as ‘natural’—a mineral, herb or otherwise—doesn’t automatically suggest it is safe. Natural products can hurt you too, if used in the wrong way and in misguided combination with either another product or in association with an incorrect indication.

People who have used Zicam nasal spray for colds have reported a loss of their sense of smell. Sometimes it is immediate. For others the loss occurred after prolonged use. Some had their sense of smell return after they stopped using Zicam. Others are fearing that their smell loss (and concurrent loss of the ability to taste food) may be permanent, and lawsuits have been launched.

All, because of zinc. Zinc on its own has a benefit to the human body. It’s actually integral, in proper balance with copper, to maintaining a healthy system. However, zinc up the nose is apparently a problem, as various studies and a flood of reports to the FDA now show.

Would this have happened, had this product been required to go through the rigorous FDA approval process?

The FDA is under the gun due to the perception of lax oversight. The agency’s critics cite too many close ties, funding and otherwise, with pharmaceutical companies that only serves to cloud its objectivity. Defenders of the FDA cite the fact that the agency has suffered through years of chronic under-funding and staff shortages and thus cannot hope to cope with a regulatory environment that now sees drugs and medical devices increasingly manufactured offshore.

And now this.

The FDA needs to promote to the American consumer that it does not have jurisdiction over homeopathic products—at least at the approval stage—and therefore the consumer cannot assume that a homeopathic product he is buying comes with the FDA stamp of approval.

Either that, or Congress needs to provide a massive funding and staffing boost to the FDA in order to undertake its current mandate, together with the adoption of a new mandate to regulate the homeopathic industry.

The FDHA—the US Food, Drug and Homeopathic Agency.

Has a nice ring to it.  

Tags: FDA, Homeopathic, Zicam
Posted in Drugs/Medical, Emerging Issues | 9 Comments »

What You Should Know About Drug Studies

November 19th, 2009. By Kristine B

In light of the recent release of the results from the ARBITER 6-HALTS trial regarding Zetia and Niaspan, there may be questions about what drug studies are and why they are important. This week, Pleading Ignorance examines drug studies: what they do, what they don’t do and what you should know about them.

Drug Studies: What They Do (Timing is Everything)

The names of the drug studies are impressive, aren’t they? Names like ARIBITER 6-HALTS, ENHANCE, RECORD and so on. The fancy thing is that all the letters in the names mean something (an acronym!)—but no one ever remembers what the heck they mean, save of course the folks conducting the test. So the catchy name is fine for the rest of us. (By the way, ARBITER 6 HALTS stands for “Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6–HDL and LDL Treatment Strategies“—say that fast 6 times). Once you’re beyond the name though, it’s important to know at what point in time the study is being done—after all, the studies are designed to show something. The timing in which the drug is tested will clue you in to what information the researchers are looking for.

Drug studies that are done before the drug is approved by the FDA (known as clinical trials), are done to prove…

• that a new drug is at least as effective as an older drug
• that the new drug is more effective than just standard therapy alone, or
• that the benefits of the new drug outweigh the risks (see, they’re watching out for you!)

If the studies are done after the drug is approved, they may be done to… Read the rest of this entry »

Tags: Drug Studies, Drugs, FDA, Pleading Ignorance
Posted in Drugs/Medical, Pleading Ignorance | No Comments »

Online Pharma Advertising…can’t wait

November 17th, 2009. By AbiK

Actually I can. You know how drug advertisements look in magazines—it can be like 3 pages of text (aka “product disclosure”) that runs on and on and interrupts whatever you’re reading. Heaven help you if you’re reading Reader’s Digest where 3 pages suddenly becomes 5 due to the smaller format. And if you do take a moment to glance at the ad, you’ve got to be thinking that something that takes that much explaining maybe shouldn’t be taken at all. Be that as it may, enter the brave new world of online advertising…

Well, there’s just no room online to be putting all that junk. Those tightly designed banner ads would become full-page ads with all the disclosure notices included and I guarantee that after coming face to face with a few “impressions” of those, you’ll never click on that website again.

And don’t the drug companies know it. But they need to be pushing their wares online—that’s where all the “growth” is these days. So now, get this—the drug industry’s big guys like Eli Lilly and Pfizer are turning to the FDA for guidance on how to push their goods online. Why? The current FDA guidelines for advertising in traditional print media (magazines, newspapers) or t.v. require all that disclosure information is shown prominently. But there aren’t really any guidelines set for new media—so everyone’s playing by the rules of traditional media, and clearly that’s not good.

Not good for who? Big pharma, but also the bigger online media companies. See the online Read the rest of this entry »

Tags: Big Pharma, FDA, Online Advertising
Posted in Drugs/Medical, Emerging Issues | No Comments »

What’s in Your Kid’s Favorite Drink? (Big Brother wants to know…)

November 16th, 2009. By LucyC

College kids, caffeine and alcohol. How many red flags does that sentence raise for you? Well, it’s raised a few at the Food and Drug Administration (FDA), specifically, is adding caffeine to alcoholic beverages legal, and is it safe from a health perspective? Short answer: the Agency isn’t sure…or at least that’s how it appears. 

So, last week the FDA issued a press release alerting the public about its latest course of action on this issue—which by the way is not new. The Wall Street Journal wrote a piece on this in August, stating “Last year, [2008] about a dozen attorneys general secured settlements with beer giants Anheuser-Busch InBev NV and MillerCoors LLC, which agreed to remove caffeine, guarana and other stimulants from drinks such as Sparks.” 

But that’s another story. I digress. The FDA press release informed the public that it has issued letters to 30 manufacturers of caffeinated alcoholic beverages—basically putting them on advisement that the whole issue is under investigation. The crux of the matter is:

“Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the Read the rest of this entry »

Tags: alcohol, alcoholic beverages, caffeine, FDA
Posted in Emerging Issues | No Comments »