Pharmacist Erik Mogalian and assistant professor Paul Myrdal of the University of Arizona's College of Pharmacy explain.
A brand-name drug product is originally discovered and developed by a pharmaceutical company. In order for the company to market and sell their product they must first gain approval from the Food and Drug Administration (FDA) by submitting a New Drug Application. In this documentation the company submits data to establish a drug's clinical safety and efficacy. Other studies determine the characteristics of the drug dosage form, including the manufacturing process, drug stability, purity, strength, and how it dissolves. Once the drug receives FDA approval, the innovator company can then exclusively market and sell this 'brand-name' product for as long as the company has patent protection. A 2000 study published in the Journal of Health Economics estimated that bringing a new drug to market costs the innovator on average $802 million over a period of 10 to 15 years. A patent allows the innovator to sell its product exclusively in order to recoup money spent during development and to generate a profit.
The difference between a brand-name product and a generic one is designed to be transparent. Once the patent life expires on a brand-name drug product, it is eligible to be made into a "generic drug." To do this, the generic drug manufacturer must ensure that the drug they are producing contains the same active ingredient(s) as the brand-name product, in the same dosage form, at the same dose or concentration, and for the same route of administration (for example, amoxicillin 500 milligram (oral) capsule). The drug may differ in color, shape, taste, inactive ingredients, preservatives and packaging, however. Because of these differences, the generic drug manufacturers are required to submit additional paperwork to the FDA to prove that their product is manufactured in accordance with good manufacturing practices (GMPs), and is as pure and stable as the brand-name product. Additionally, the generic needs to meet pharmacokinetic parameters in the body, which means it must dissolve (in a beaker) at the same rate and to the same extent as the original. This process ensures that the two products are bioequivalent because if product A and product B dissolve in a virtually identical manner, then they should behave the same in the body.
Thus, a drug that contains the same active ingredient, in the same amount, in the same form, dissolving at the same rate in equal amounts may be granted acceptance for substitution for a brand-name product. If it is accepted, the drug can be prescribed no differently than the brand-name product. Once all the equivalency tests have been conducted, the generic drug is considered a therapeutic equivalent. This means that the drug will do the same thing via the same mechanism, and will also follow the same distribution, metabolism and elimination pathways in the body. One publication that lists this sort of information is called the Orange Book. This publication rates generic drugs in accordance with their respective brand-name products and gives the FDA substitution recommendations. The FDA website (www.fda.gov) is also a very good source.
Philip DeShong, professor of chemistry and biochemistry at the University of Maryland, offers the following explanation:
The major difference between a brand-name pharmaceutical and its generic counterpart is neither chemistry nor quality, but whether the drug is still under patent protection by the company that initially developed it. When a company develops a new drug, it typically receives a patent that lasts 20 years. This means that other pharmaceutical companies may not sell this substance without permission from the developing company during that time. Once the patent expires, however, other companies may begin to sell the compound. Because companies wishing to sell the generic drug have much lower development costs, they can produce it at a lower unit cost, sell it for less and still make a profit on the sale. The FDA regulates manufacture of both brand-name and generic drugs and the overall quality should be comparable. (This is an area of some contention between companies, but to a first approximation the statement is valid.)
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8 Comments
Add CommentI was told , by a pharmacist years ago, that as long as a generic drug comes within 30% of FDA guide lines that it is allowed to pass...I don't believe this has changed.
Reply | Report Abuse | Link to thisI was told pharma drug distributors (middlemen)
Reply | Report Abuse | Link to thischarge retailers five times what drug companies
charge the middlemen. But you can tell how rich
an industry is by their TV commercials, such as
drug company's. Whose are slicker?
I think the pharmaceutical industry is a govern-
ment-protected monopoly. I think doctors are
trained to use their products because they support
their professors and schools. I think the laws to
make drugs safe and effective don't work as well
as they should. They would probably have better
net results if more responsability was allowed
consumers, releiving us of costs most can't afford.
Germany is a freer country that way and they have
a very outstanding tradition of medical excellence.
There was an expose by the nytimes on cheap, inf-
erior chemical ingredients made in China and sold
to drug companies all over the world to mix in their
products. Some are deadly.
The worst evil is "The New Freedom Initiative"
(what doublespeak!). Drug companies have convin-
ced state legislatures to buy mind-altering drugs
and abuse children with them via education
departments, if their teachers think they behave
abnormally - for any reason. In other words, if
they cause any problem, they are drugged, some-
times against the parent's will as well as theirs.
I think many children can't sit still or concentrate
because they are abused by parent's tobacco at
home. Nicotene is a brain irritant for many. Also
there are so many chemicals in candies and white
sugar makes many children manic. So the state
should give them more poison to compensate?
Adderall is amphetamine salts. Some school mas-
sacres were done by students on antidepressants.
I prefer nutrients, herbs & nutraceuticals. I think
there's generally more bang for your buck, they are
often safer and more effective. Megadosing most
micronutrients is safe and can do wonders. There
are about eight grades of quality in natural supple-
ments, which can make all the difference.
Brain nutrients and herbs have made me smarter
than ever. I learn like when i was at 11. I'm going
on 54. I find brain nutrients with intentional, int-
ellectual cultivation, going on 18 years, has lasting,
desired effects, even when i don't have them.
Vegie B-12, C, Ginko Biloba, DMAE-PABA, phosp-
hatidyls & others. Freshness very important.
Self-educate and experiment carefully. Tailor
dosages. Cholines & aminos come in capsules
with 10 times useful doses for me.
Nutrients are chemicals we must have to live.
Usually more is safe.
"i learn like i was at 11"? "responsability'? Smarter? oh, okay, or maybe just more paranoid. I guess an 11 year old would have a hard time spelling responsibility.
Reply | Report Abuse | Link to thisFYI, your so called "natural" suplements cause side effects and can be very damaging to the liver and other vital organs.
Just curious, do you have kids? what is your expertise to make such an all encompassing remark?
toothgirl makes a valid point. What expertise do you have to back up such a statement?
Reply | Report Abuse | Link to thisBy all means take whatever supplements you want, nobody's stopping you. However megadosing nutrients is not a the wisest or safest thing to do, nor does it benefit you more. What makes you think taking 100x the Vitamin C (for example) you need daily will do? It won't bring 100x the benefits, I wish! All that happens is that the body discards the excess through metabolic processes, as with any excess. Just like if you drink an extra 2 glasses of water, you produce more urine later, than if you drink a teaspoonful.
If you mega overdose, your body will accumulate the metabolic by products, some of which may be toxic or harmful.
It would be much safer (and less wasteful) to consume a variety. The body synthesises what it needs from whats provided and it excretes what it doens't.
The rest of your comment is incoherent, you don't make your points clear, and it sounds like a rant from an educated illiterate (no offence intended).
Some of your points speak of a totally different issue and are somehow linked to others! Like "abused by parent's tobacco at home". Surely that is the fault of the parents? You're also dragging poilitics (general term, NOT layman's term) into the issue.
Until there is more hardline evidence (and research) to show HOW all of these "herbs" and remedies have effect, you can't expect the scientific community to accept your word as fact, when the opposing side DOES show.
(anyways)
The article can be summed up into just 4 words: nothing! Except the price...
However the rest of it was interesting :)
Why can't the developer over this drug to all other drug companies at a price that will offset the developing cost. If the response to this offer is excepted then these companies that except this cost may produce it while it is still under patent. It would add balance to the market and produce competition earlier and aid companies to develop faster. Thus aiding the consumer.
Reply | Report Abuse | Link to thisRufus
Interesting but not entirely helpful article. The biggest benefit of taking a brand-name drug is that you know you're getting the "standard", albeit at higher cost. The biggest benefit of taking a generic is the cost savings even though there may be some risk that it may not be quite as effective as or cause more side-effects than the original version. I suspect (but have no proof) that in most cases a generic is equivalent to or nearly equivalent to the original.
Reply | Report Abuse | Link to thisI disagree with one of the opinions above that doctors (in general) write for trade-name drugs due to some reciprocal agreement with the drug companies. Most states permit pharmacists to substitute the generic (if available) unless the physician specifies that only the trade-name drug can be prescribed. (This is not the norm.) Most physicians will have the patient's best interests at heart; they do not get compensation from drug companies for writing for a trade-name versus a generic drug. You can always ask your physician to write a prescription for the generic version (if available) as well.
There is no question that pharmaceutical companies make a lot of profit and are spending their money on TV ads to influence consumer drug choices and well as on our legislators to influence health legislation to their benefit (e.g., Medicare Part D). This discussion is outside of the scope of the original topic.
MrMouse, your Pharmacist friend if quoted correctly is not correct in that generic drugs may differ from brand name by 10% not 30%. Some confusion lies in the allowance for one generic drug to be 10% higher in the patient's blood stream for example than its brand name counterpart and another generic drug may be 10% lower. These two specific generic drugs then could be said to be 20% different from each other, but not to the brand name drug. The 30% is not correct in any sense of it's usage.
Reply | Report Abuse | Link to thisI hope this clarifies some of the mystery. Richshav, BSPharm
The problem with generics is that the equivalency testing is done "in house" with no oversight by the FDA. The FDA does no independent testing, but simply accepts the paperwork of the drug company at face value. This is like having the fox guarding the hen house. While any difference is apparent with psychoactive drugs or those with a measurable effect like blood pressure medication, for those with no immediately apparent effect like antibiotics it is impossible for the consumer to know if what the they are taking is as effective as the brand name.
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