Generic drugs. Rant

[Clarence Martin]

Not every Generic Drug is the same as it's Brand Name counterpart. There are some groups of Drugs that are so sensitive when it comes to either being correct in dosage, too low of dosage that they don't do any good, or too high in it's active ingredient, that it makes the Drug toxic. It is a small group of Drugs. Epilepsy drugs are the example I am referring to. Take Dilantin , for Example. It has a Generic "Equivalent". I would NEVER take it. When you go to the Pharmacy and get a generic drug filled, you can have one generic brand one Month, and a different generic brand of the same drug the next Month. The Insurance Companies love it when a Generic drug comes on the market. Who could blame them. They spend less for the drug, it saves the consumer and the Insurance company money. Both win in that situation. But, like I said before, there is that small group of Drugs that even though there are Generics in place of those Brand Names, it is better to stick with the Brand Name Drug.

[Ken Fitzgerald]

From the FDA's website and page concerning generic drugs, a copy and paste:

The generic drug approval process includes a review of scientific data on manufacturing, ingredients and performance. A generic drug approved by FDA that would be substituted by a pharmacist for a brand name drug will:

• Contain the same active ingredients as the brand-name drug. Active ingredients make the drug effective against the disease or condition it is treating. Inactive ingredients may vary.
• Be identical in strength, dosage form and route of administration. If the brand-name drug is a capsule and is taken orally, so is the generic.
• Treat the same medical condition.
• Be absorbed into the bloodstream at a similar rate and over the same period of time.
• Meet the same requirements for identity, strength, purity and quality.
• Be manufactured under the same strict standards that FDA demands of brand-name drugs.
  
  That's not to say a manufacturer won't break the law and do otherwise but there's nothing to keep the brand name manufacturer from do so either.

[Wayne Lomman]

I can't comment on prescription drugs in the US market, but I do know that the FDA conducts on the ground audits of overseas manufacturers. They are extremely thorough. Cheers

[Al Launier]

Thanks Ken, that was informative.

[Art Mann]

I take generic drugs for cholesterol, triglycerides and blood pressure. They all work well for me and 2 of them include no insurance copay and cost me nothing. I am happy I have the generic option.

[Greg Peterson]

Just like the CALM act, industry will find a loophole in the regulations.

These FDA regulations are, IMO, generic.

In this instance, the FDA requires the generic to be absorbed in a similar manner. I'm sure the lawyers can and do create a generous amount of latitude with that.
I've taken generic, or more accurately copy cat dtugs, both over the counter and prescription and noticed a different, less effective result. Or should I say, I experienced a similar result?
Similar is an objective measure.

[Brent Gamble]

I take generics...if my Doc approves. My daughter has epilepsy. Of course she must take anticonvulsant drugs, and will need them for the rest of her life. Without going in to all of the details, the drug she takes has just come off patent and our insurance company has stopped paying for the brand name. Her doctor has gone round and round with the insurance co. but they insist they won't pay for the brand until she tries the generic and it doesn't work. HUH? In her case "doesn't work" means she has tonic-clonic (grand mal) seizures. The bad, dangerous ones. It is well documented that people with epilepsy are prone to problems with generic meds once they've acheived control on the brand med. Google "generic anticonvulsants". It's a risk we are not willing to take with our daughter's well being. Generic drugs are required by the FDA to be the same within a given range and they can vary from one manufacturer to the next. They are almost, but not quite the same, and they do not, in every case work indentically. Sorry for the rant, but this is a touchy subject for me.

[Greg Peterson]

Generics, by definition are not the same.

[Frank Drew]

Generics, by definition are not the same.

Yes, the bottles they come in are different.

[Greg Peterson]

Yes, the bottles they come in are different.

Well, more than the bottle is different.

"But generic drugs diverge from the originals far more than most of us believe. For starters, it’s not as if the maker of the original pharmaceutical hands over its manufacturing blueprint when its patent runs out or is challenged. The patent reveals the components, but it doesn’t explain how to make the drug. In reality, manufacturing a generic requires reverse engineering, and the result is an approximation rather than a duplicate of the original."

http://fortune.com/2013/01/10/are

The article goes on to explain that the maximum concentration can not fall below 20% or exceed 25% that of the brand name. That is a 45% variance.

The production of a generic is backward engineered, and as such, some of the previously considered inert ingredients likely serve a specific purpose in the distribution and absorption os the active ingredient.
As the article states, the regulations are overly broad.

Generics are not the same as their brand name counerpart. They may be close enough in some applications, but there is no evidence nor requirement for generics to identical. In the auto parts business, we call it a functional equivalent.

[Mike Henderson]

I never looked at pharmaceutical patents, but the basis of a patent is that it teaches (someone "skilled in the arts") how to do the patented thing. The deal our patent system makes with an inventor is that the inventor discloses how to make something and the inventor gets a patent for a certain number of years.

If that's true I assume a company would be able to use the patent as a guide (for someone skilled in the arts) to make the generic medicine. For people in the business, I guess there's not a lot of mystery about how to make a certain drug. After all, it's 17 to 20 years after the drug was patented.

Mike

[Rich Engelhardt]

Here's a little something to get your blood pressure up..
http://www.nytimes.com/2013/10/13/us..._20131013&_r=0

Since I have COPD, the subject of generic inhalers - or more exactly - the lack of such things - is something I have a special interest in.

The above article & this one from Mother Jones:
http://www.motherjones.com/kevin-dru...s-so-damn-much

Are real eye openers to the world of - - (generic) drug pricing...

[Greg Peterson]

From the Fortune article I linked to above:

"At a meeting of the FDA’s advisory committee for pharmaceutical science and clinical pharmacology in 2011, Dr. James Hennessey, clinical director of the division of endocrinology at Beth Israel Deaconess Medical Center in Boston, presented evidence of three different generic formulations of levothyroxine (used to treat hypothyroidism). All were more potent than the branded version and varied from one another. One was 12.5% above, another 9% above, and another 3% above the brand name’s potency. All had been approved as bioequivalent. Noting that “less than 10% dose intervals make clinical differences,” Hennessey told the advisory committee meeting, “These differences are too large.”

These three generic versions of levothyroxine were within FDA regulations, yet obviously were not identical to the name brand or even bioequivalent to the name brand.

So FDA regulations are not adequate for all generic medications.

[Ken Fitzgerald]

Greg,

There is also nothing from stopping brand name drugs from having the same type of variations between production runs.

I would love to know what the fine doctor's views were before he found these inconsistencies and who pays his paycheck.

And how many total manufacturers produce and sell the generic levothyroxine?

Is this the only 3 who manufacture this generic or is it 3 out of 1000 who make this generic?

[Greg Peterson]

Ken, we'll have to agree to disagree on a very fundamental level in this discussion. I'll leave it at that.