Have you noticed that you can buy a drug with a brand name that will be very expensive, and at the same time buy the same generic version of the same drug cheaper. The generic usually have the same main ingredient, same dosage, and even the same effect on the body, yet the brand name is more expensive than the generic one. Most times I wonder if this is because one works better than the other but at the end, we realize that they do the same job. So how did this happen and how do people or company begin to own chemicals?
In the 1900s, getting drugs was basically simple as people were either getting Ethical drugs, or Patent drugs. Ethical medicines were drugs that had positive effect which was documented on the body and these drugs included Quinine, Aspirin, Digitalis, and other drugs that were known to have positive effects.
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In the same way, people who requested for patent medicines were requesting for drugs that the ingredients were secret and known only to the salesman or sometimes scientists that created them. In most cases, the secret ingredients were either Opium, Spices, Sugar, Alcohol, or even cocaine. While these drugs were very popular, they were not completely great at treating diseases. An example of patent medicine at that time was Snake Oil, others includes, Dr. Winchell's Teething Syrup, Sloan's Liniment, Sojen Cough Syrup, and Dr Harter's Lung balm (oh this name is ridiculous). With patent medicine, it was more of an endorsement than a trademark.
With drugs, the active ingredient was the reason why it would work and companies could not own the property right to the active ingredients used to create the drug but they could on the patent to their brand. A very good example is in 1899 when Bayer started selling a medicine that contained Acetyl salicylic acid and in other o be able to have a patent, they branded it Aspirin. With patent in drugs, drug makers were able to have a monopoly of the market for a short time and make money from it since there was no alternative.
You might have been wondering that instead of hearing names like Dr pepir Lung balm, you hear brand names and this time there are lots of changes. This is as a result of certain events. One of which happened in 1937, where chemists at the Massengill company in Tennessee released an elexir that killed over 100 people while trying to tweak a powdered sulfanilamide into a syrup. While the powder couldn't dissolve in water, it dissolved in Diethylglycol (antifreeze). These led to the death of over a 100 people, and while the company used Dietylglycol, the name Elixir meant that the solution was ethanol but it wasn't ethanol.
In the 1950s, another tragedy occurred as Chemie Grunenthal released Thalidomide (a sleeping pill) and different companies had different brand names for the same drug thereby causing the market to have over 30 different types of Thalidomide but then this drug had serious effect on pregnant women causing them to give birth to deformed children who would have shortened arms, legs and even missing fingers or deformed fingers. This affected over 10 thousand infants before the drug was recalled.
This events led to the Drug Amendment Act of 1962 (Kefauver-Harris Amendment). It was a safety law and it led to how we test drugs today as drugs needed to go through rigorous testing to be approved for use. This led to delay in approval time from 2 years to about 7 or 12 years, and this caused pharma company to take a patent on a drug that is yet to be approved as a way to insure their money since patent for drugs was a 17 years monopoly from the day of filing the patent.
While brand name drugs were going to spend more time on development and testing, Generic drug applications would not need clinical trials as they would apply for apply for approval via Abbreviated New Drug Application (ANDA) and it was literature base. The FDA used the Orange Book to write list of Brand drugs as well as their generic equivalent.
We can tell that with this, the brand drug companies would be doing the work, while the generic drugs make money from less research. With this, the Hatch Waxman Act was created where branded drug companies have 5 years exclusivity provided the drug was innovated. When the generic is out, they must show bioequivalence with the branded drug.
In 1992, the Generic Drug Enforcement Act was passed but it was passed to regulate the creation of generic drugs. If we are to look at both generic and named brand version of drugs, they have the same efficacy and almost same safety degree but then, lots of people prefer to get named drugs because they want to be able to hold a company with a brand name responsible for their health.
Reference
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2690298/
https://www.jstor.org/stable/20059191
https://www.jstor.org/stable/26656214
https://www.fda.gov/media/110437/download
https://www.jstor.org/stable/24631986
https://www.nyhistory.org/blogs/snake-oil-almanacs-patent-medicine-advertising-in-the-19th-century
https://www.jstor.org/stable/41109885
https://www.jstor.org/stable/44442097
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1894700/
https://ptcbtestprep.com/sulfanilamide-disaster-what-happened/
https://www.gvsu.edu/cms4/asset/F51281F0-00AF-E25A-5BF632E8D4A243C7/kefauver-harris_amendments.fda.thalidomide.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4101807/
https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters
https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda