Pharmaceutical Industry

The pharmaceutical industry is the collective business enterprise employed in discovering, developing, manufacturing, and marketing legal drugs.

• Controversies
• List of pharmaceutical companies

The origins of the pharmaceutical industry can be traced back to the chemical industries (of the late nineteenth century) in the upper Rhine Valley of Switzerland. These industries were producing dye stuffs. When dye stuffs were found to have antiseptic properties, a number of these industries turned into pharmaceutical industries e.g. Hoffman-La Roche, Sandoz, Ciba-Geigy, etc.

Another origin is the drug store. The first known drug store was opened by Arabian pharmacists in Baghdad in 754, and many more soon began operating throughout the Islamic world and Europe. By the 19th century, many of the drug stores in Europe and North America had developed into larger pharmaceutical companies.

Most of today's major pharmaceutical companies were founded in the late 19th and early 20th centuries. https://web.archive.org/web/20100120103354/https://www.scribd.com/doc/21734187/History-of-Pharmaceutical-Industry

The roots of the pharmaceutical industry lie back with the apothecaries and pharmacies that offered traditional remedies as far back as the middle ages, offering a hit-and-miss range of treatments based on centuries of folk knowledge.

But the industry as we understand it today really has its origins in the second half of the 19th century. Whilst the scientific revolution of the 17th century had spread ideas of rationalism and experimentation, and the industrial revolution had transformed the production of goods in the late 18th century, the marrying of the two concepts for the benefit of human health was a comparatively late development.

Merck in Germany was possibly the earliest company to move in this direction. Originating as a pharmacy founded in Darmstadt in 1668, it was in 1827 that Heinrich Emanuel Merck began the transition towards an industrial and scientific concern, by manufacturing and selling alkaloids.

Similarly, whilst GlaxoSmithKline’s origins can be traced back as far as 1715, it was only in the middle of the 19th century that Beecham became involved in the industrial production of medicine, producing patented medicine from 1842, and the world’s first factory for producing only medicines in 1859.

America’s pharmaceutical founding fathers

Meanwhile in the USA, Pfizer was founded in 1849 by two German immigrants, initially as a fine chemicals business. Their business expanded rapidly during the American civil war as demand for painkillers and antiseptics rocketed.

https://web.archive.org/web/20200929225934/https://pharmaphorum.com/r-d/a_history_of_the_pharmaceutical_industry/

The period between 1918 and 1939 was marked by two breakthroughs that presaged the arrival of the pharma industry as we know it today. The first was insulin – Frederick Banting and colleagues managed to isolate insulin that could treat diabetes, up until that point a fatal condition. But it was only in collaboration with the scientists at Eli Lilly that they were able to sufficiently purify the extract and industrially produce and distribute it as an effective medicine.

The second was penicillin, a discovery of an impact possibly unparalleled by any other in medicine. After Alexander Fleming’s initial discovery of the penicillium mould’s antibiotic properties in 1928, and Howard Florey and Ernst Chain’s further experimentation, a government-supported international collaboration including Merck, Pfizer and Squibb worked on mass producing the drug during World War Two, saving thousands of soldiers’ lives. The immense scale and sophistication of the penicillin development effort marked a new era for the way the pharmaceutical industry developed drugs. The war had also encouraged research into everything from new analgesics to drugs against typhus, with a great deal of collaboration between the companies and government.

https://web.archive.org/web/20200929225934/https://pharmaphorum.com/r-d/a_history_of_the_pharmaceutical_industry/

Pharmaceutical Research and Manufacturers of America, also known as PhRMA, is one of the largest and most influential lobbying organizations in Washington. Representing 48 pharmaceutical companies.

PhRMA has 20 registered lobbyists on staff and has contracted with dozens of lobby and PR firms – including Akin, Gump, Strauss, Hauer & Feld, Barbour Griffith & Rogers, DCI Group and The Dutko Group– to promote its members' interests. PhRMA has a record of hiding its lobbying and PR activities, often by paying other organizations, such as United Seniors Association (USA) or the Consumer Alliance, to advocate industry-friendly policies.

PhRMA was a member of ALEC's “Private Enterprise” Board of Directors as of 2016, with lobbyist Jeff Bond representing it on the board.[11] PhRMA was also a 2011 recipient of ALEC's Private Sector Member of the Year Award, a “Chairman” level sponsor of 2011 ALEC Annual Conference, which equated to $50,000 in 2010, a sponsor of Louisiana Governor Bobby Jindal's plenary luncheon speech at the 2011 ALEC Annual Conference, and a “Vice Chair”-level sponsor of the 2016 ALEC Annual Conference. A list of ALEC corporations can be found here.¹⁾

ALEC is a corporate bill mill. It is not just a lobby or a front group; it is much more powerful than that. Through ALEC, corporations hand state legislators their wishlists to benefit their bottom line. Corporations fund almost all of ALEC's operations. They pay for a seat on ALEC task forces where corporate lobbyists and special interest reps vote with elected officials to approve “model” bills. Learn more at the Center for Media and Democracy's ALECexposed.org, and check out breaking news on our ExposedbyCMD.org site.

Soon after Wisconsin Governor Scott Walker came into office, Walker and GOP state legislators pushed for the adoption of Wisconsin Act 2, an ALEC-influenced bill that benefitted the bottom line of PhRMA members. The bill seeks to implement “tort reform” by “limiting the ability to hold corporations accountable for causing injury or death” and “make it easier for corporations like drugmakers to escape liability for manufacturing dangerous products or products with insufficient warnings about hazards.” The legislation drew heavily from ALEC Model bills on tort reform, including the “Constitutional Guidelines for Punitive Damages Act” and the “Product Liability Act.”²⁾

• Mar 1, 2019 Public citizen: Companies Are Reaping Benefits from Social Influencers, and Big Pharma Wants In

Different governing bodies regulate the pharmaceutical industry according to their own legal and governance structures.

(select highlights not full list)

1905 - The American Medical Association, through its Council on Pharmacy and Chemistry, initiates a voluntary program of drug approval that would last until 1955. To earn the right to advertise in AMA and related journals,companies submitted evidence, for review by the Council and outside experts, to support their therapeutic claims for drugs.

1914 - The Harrison Narcotic Act requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.

1930 - The name of the Food, Drug, and Insecticide Administration is shortened to Food and Drug Administration (FDA) under an agricultural appropriations act.

1938 - The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions- Extending control to cosmetics and therapeutic devices.- Requiring new drugs to be shown safe before marketing, starting a new system of drug regulation.

1951 - Durham-Humphrey Amendment defines the kinds of drugs that cannot be used safely without medical supervision and restricts their sale to prescription by a licensed practitioner.

1966 - FDA contracts with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4,000 drugs approved on the basis of safety alone between 1938 and 1962.

1970 - In Upjohn v. Finch the Court of Appeals upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy. FDA requires the first patient package insert- oral contraceptives must contain information for the patient about specific risks and benefits.

1977 - Introduction of the Bioresearch Monitoring Program as an agency-wide initiative ensures the quality and integrity of data submitted to FDA and provides for the protection of human subjects in clinical trials by focusing on preclinical studies on animals, clinical investigations, and the work of institutional review boards.

1981 - FDA and the Department of Health and Human Services revise regulations for human subject protections, based on the 1979 Belmont Report, which had been issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The revised rules provide for wider representation on institutional review boards and they detail elements ofwhat constitutes informed consent, among other provisions.

1987 Investigational drug regulations revised to expand access to experimental drugs for patients with serious diseases with no alternative therapies.

1988 - Food and Drug Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary and the Commissioner for research, enforcement, education, and information.

The Prescription Drug Marketing Act bans the diversion of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, subpotent, and counterfeit drugs to the public. The new law requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.

1991 -The policy for protection of human subjects in research, promulgated in 1981 by FDA and the Department of Health and Human Services, is adopted by more than a dozen federal entities involved in human subject research and becomes known as the Common Rule. This rule issues requirements for researchers who obtain and document informed consent, secures special protection for children, women, and prisoners, elaborates on required procedures for institutional review boards, and ensures that research institutions comply with the regulations.

2004 - Project BioShield Act of 2004 authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the U. S., among other provisions.

2005 - Formation of the Drug Safety Board is announced, consisting of FDA staff and representatives from the National Institutes of Health and the Veterans Administration. The Board will advise the Director, Center for Drug Evaluation and Research, FDA, on drug safety issues and work with the agency in communicating safety information to health professionals and patients. Three final guidances were published to fulfill FDA's commitment to the risk management performance goals that are part of the 2002 reauthorization of PDUFA. * Premarketing Risk Assessment * Development and Use of Risk Minimization Action Plans * Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

https://web.archive.org/web/20210306155449/https://www.fda.gov/media/74571/download

The Thalidomide scandal of 1961 prompted an increase in the regulation and testing of drugs before licensing, with a new amendment to US Food and Drug Administration (FDA) rules demanding proof of efficacy and accurate disclosure of side-effects for new medications (the Kefauver-Harris Amendment) being implemented in 1962. Likewise, the 1964 Declaration of Helsinki put greater ethical structures on clinical research, clearly cementing the difference between production of scientific prescription medicines and other chemicals. https://web.archive.org/web/20200929225934/https://pharmaphorum.com/r-d/a_history_of_the_pharmaceutical_industry/