The development of any new pharmaceutical is a complex and expensive project. In many instances, the research divisions within pharmaceutical companies spend years studying aspects of the biology and biochemistry of the disease in question (malaria, cancer or bacterial infections, for example) in an effort to develop an approach to attack the disease. Once the biology of the disease is understood and an assay or animal model is in place, medicinal chemists begin to prepare potential chemical inhibitors. From initial results in the biological system, the chemists then prepare new, and hopefully improved, lead compounds. This sort of teamwork between the chemists and biologists often takes years before a final group of lead compounds is ready for more significant evaluation. At this point, a candidate drug is evaluated for toxicity, efficacy and other properties in an animal model (rats or dogs, for instance). This evaluation process may last years. Assuming that the drug candidate is successful in these tests, it then enters into Phase 1, Phase 2 and, finally, Phase 3 clinical trials in humans. The FDA establishes the number of patients required for each phase of the clinical trials according to guidelines based on the disease being treated. For example, a drug candidate for a disease that afflicts only 10,000 people would have a smaller number of patients in its trials than would a potential drug to fight a disease that afflicts millions such as high blood pressure. At the end of the clinical trials the company presents its data to the FDA, which then decides whether or not to approve the drug for sale to the public.
On average, the cost of developing a new drug is now well in excess of $1 billion and takes more than 10 years. (Again there is a wide discrepancy between estimates of the actual cost and time required, but I have attempted to provide an unbiased estimate using a variety of sources.) Because patents are typically granted during the initial research phase of investigation, a company developing a new drug usually has 10 years of patent protection (at the maximum except in rare cases of "orphan diseases") during which the drug is on the market. Thus, the higher prices of brand-name prescription drugs arise because companies have to recoup their investment during the lifetime of the patent, typically seven to 10 years, as well as make a profit on the sale.
This response represents a simplified case study and there are many examples of drug development that do not fit this profile precisely. For some brand-name drugs the developmental time frame is shortened somewhat, but there are many others in which it can last much longer.
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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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