Pharmaceutical Industry in the U. Together with Canada and Mexico, it represents the largest continental pharma market worldwide. The United States alone holds over 45 percent of the global pharmaceutical market.
History[ edit ] Mids — From botanicals to the first synthetic drugs[ edit ] The modern pharmaceutical industry traces its roots to two sources. The first of these were local apothecaries that expanded from their traditional role distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid s.
By the late s, German dye manufacturers had perfected the purification of individual organic compounds from coal tar and other mineral sources and had also established rudimentary methods in organic chemical synthesis.
Epinephrine, norepinephrine, and amphetamine[ edit ] By the s, the profound effect of adrenal extracts on many different tissue types had been discovered, setting off a search both for the mechanism of chemical signalling and efforts to exploit these observations for the development of new drugs.
The blood pressure raising and vasoconstrictive effects of adrenal extracts were of particular interest to surgeons as hemostatic agents and as treatment for shock, and a number of companies developed products based on adrenal extracts containing varying purities of the active substance.
InJohn Abel of Johns Hopkins University identified the active principle as epinephrinewhich he isolated in an impure state as the sulfate salt. Industrial chemist Jokichi Takamine later developed a method for obtaining epinephrine in a pure state, and licensed the technology to Parke-Davis.
Parke-Davis marketed epinephrine under the trade name Adrenalin. Injected epinephrine proved to be especially efficacious for the acute treatment of asthma attacks, and an inhaled version was sold in the United States until Primatene Mist. While highly effective, the requirement for injection limited the use of epinephrine[ clarification needed ] and orally active derivatives were sought.
A structurally similar compound, ephedrineactually more similar to norepinephrinewas identified by Japanese chemists in the Ma Huang plant and marketed by Eli Lilly as an oral treatment for asthma.
Following the work of Henry Dale and George Barger at Burroughs-Wellcome, academic chemist Gordon Alles synthesized amphetamine and tested it in asthma patients in The drug proved to have only modest anti-asthma effects, but produced sensations of exhilaration and palpitations.
Amphetamine was developed by Smith, Kline and French as a nasal decongestant under the trade name Benzedrine Inhaler. Amphetamine was eventually developed for the treatment of narcolepsypost-encephalitic parkinsonismand mood elevation in depression and other psychiatric indications.
It received approval as a New and Nonofficial Remedy from the American Medical Association for these uses in and remained in common use for depression until the development of tricyclic antidepressants in the s.
It was sold by Bayer under the trade name Veronal InHermann Emil Fischer and Joseph von Mering disclosed their discovery that diethylbarbituric acid, formed from the reaction of diethylmalonic acid, phosphorus oxychloride and urea, induces sleep in dogs.
The discovery was patented and licensed to Bayer pharmaceuticalswhich marketed the compound under the trade name Veronal as a sleep aid beginning in Systematic investigations of the effect of structural changes on potency and duration of action led to the discovery of phenobarbital at Bayer in and the discovery of its potent anti-epileptic activity in Phenobarbital was among the most widely used drugs for the treatment of epilepsy through the s, and as ofremains on the World Health Organizations list of essential medications.
Today, amphetamine is largely restricted to use in the treatment of attention deficit disorder and phenobarbital in the treatment of epilepsy. InOskar Minkowski and Joseph von Mering found that diabetes could be induced in dogs by surgical removal of the pancreas. InCanadian professor Frederick Banting and his student Charles Best repeated this study, and found that injections of pancreatic extract reversed the symptoms produced by pancreas removal.
Soon, the extract was demonstrated to work in people, but development of insulin therapy as a routine medical procedure was delayed by difficulties in producing the material in sufficient quantity and with reproducible purity.
The researchers sought assistance from industrial collaborators at Eli Lilly and Co. Walden of Eli Lilly and Company found that careful adjustment of the pH of the extract allowed a relatively pure grade of insulin to be produced.
Under pressure from Toronto University and a potential patent challenge by academic scientists who had independently developed a similar purification method, an agreement was reached for non-exclusive production of insulin by multiple companies. Prior to the discovery and widespread availability of insulin therapy the life expectancy of diabetics was only a few months.
The drug was given the commercial name Salvarsan. Arsphenamine was prepared as part of a campaign to synthesize a series of such compounds, and found to exhibit partially selective toxicity.
Arsphenamine proved to be the first effective treatment for syphilisa disease which prior to that time was incurable and led inexorably to severe skin ulceration, neurological damage, and death.
This work, also based in the testing of compounds available from the German dye industry, led to the development of Prontosilthe first representative of the sulfonamide class of antibiotics.
Compared to arsphenamine, the sulfonamides had a broader spectrum of activity and were far less toxic, rendering them useful for infections caused by pathogens such as streptococci.
These were developed by a U. The first diphtheria vaccines were produced in from a mixture of diphtheria toxin and antitoxin produced from the serum of an inoculated animalbut the safety of the inoculation was marginal and it was not widely used.
The United States recordedcases of diphtheria in resulting in 15, deaths. In parallel efforts by Gaston Ramon at the Pasteur Institute and Alexander Glenny at the Wellcome Research Laboratories later part of GlaxoSmithKline led to the discovery that a safer vaccine could be produced by treating diphtheria toxin with formaldehyde.
Unsafe drugs and early industry regulation[ edit ] In over people died after ingesting a solution of the antibacterial sulfanilamide formulated in the toxic solvent diethylene glycol Prior to the 20th century drugs were generally produced by small scale manufacturers with little regulatory control over manufacturing or claims of safety and efficacy.
To the extent that such laws did exist, enforcement was lax. In the United States, increased regulation of vaccines and other biological drugs was spurred by tetanus outbreaks and deaths caused by the distribution of contaminated smallpox vaccine and diphtheria antitoxin.
This was followed in by the Pure Food and Drugs Actwhich forbade the interstate distribution of adulterated or misbranded foods and drugs.By value, the United States still leads the world in pharmaceutical production, accounting for 39 percent of world production, followed by the United Kingdom, Germany, France, and Japan.
Pharmacy and drug store sales in the United States from to (in billion U.S. dollars) This timeline depicts pharmacy and drug store sales in the United States from to Code of fair competition for the retail drug industry as revised August 26, by United States.: National Recovery Administration.
Publication date Topics Pharmaceutical industry--United States.
Publisher Washington, D.C.: U.S. Government Printing Office. AND RETURNS IN THE PHARMACEUTICAL INDUSTRY JULY The Congress of the United States Congressional Budget Office.
x HOW INCREASED COMPETITION FROM GENERIC DRUGS HAS AFFECTED PRICES AND RETURNS July 70 percent of prescription drug sales through retail pharmacies in the United States. The various sets of. The pharmaceutical industry discovers, Measles cases reported in the United States before and after introduction of the (FDA) in the United States – advance the interests of the drug companies rather than the interests of the public due to revolving door exchange of employees between the regulator and the companies and friendships.
Drug Distribution in the United States Two-class Drug System The U.S. drug distribution model is a two-class system of prescription and over-the-counter (OTC) medicines, regulated by the U.S. Food and Drug Administration (FDA).