Continued through the years The industry remained relatively small scale until the 1970s when it began to expand at a greater rate. [ Legislation allowing for strong patents, to cover both the process of manufacture and the specific products, came into force in most countries. By the mid-1980s, small biotechnology firms were struggling for survival, which led to the formation of mutually beneficial partnerships with large pharmaceutical companies and a host of corporate buyouts of the smaller firms.
Pharmaceutical manufacturing became concentrated, with a few large companies holding a dominant position throughout the world and with a few companies producing medicines within each country. Marketing changed dramatically in the 1990s. The Internet made possible the direct purchase of medicines by drug consumers and of raw materials by drug producers, transforming the nature of business.
In the US, Direct-to-consumer advertising proliferated on radio and TV because of new FDA regulations in 1997 that liberalized requirements for the presentation of risks. The new antidepressants, the SSRIs, notably Fluoxetine (Prozac), rapidly became bestsellers and marketed for additional disorders. Often, large multinational corporations exhibit vertical integration, participating in a broad range of drug discovery and development, manufacturing and quality control, marketing, sales, and distribution.
Smaller organizations, on the other hand, often focus on a specific aspect such as discovering drug candidates or developing formulations. Nature of industry Costly, risky Drug companies are like other companies in that they manufacture products that must be sold for a profit in order for the company to survive and grow. They are different from some companies because the drug business is very risky. For instance, only one out of every ten thousand discovered compounds actually becomes an approved drug for sale.
Much expense is incurred in the early phases of development of compounds that will not become approved drugs In addition, it takes about 7 to 10 years and only 3 out of every 20 approved drugs bring in sufficient revenue to cover their developmental costs, and only 1 out of every 3 approved drugs generates enough money to cover the development costs of previous failures. MUST MAKE UP FOR LOSS MAKING DRUG PURSUITS Since 2001, the Center for Drug Evaluation and Research has averaged 22.
9 approvals a year. This approval comes only after heavy investment in pre-clinical development and clinical trials, as well as a commitment to ongoing safety monitoring. THIS IS THE RIGHT WAY OF BUSINESS MUST RECOVER COST OF TRIAL AND ERROR LONG TERM COST opportunity cost of investing capital many years before revenues are realized Where pharmaceutics have been shown to cause side-effects, civil action has occurred, especially in countries where tort payouts are likely to be large. LEGAL COST.
Patent protection enables the owner of the patent to recover the costs of research and development through high profit margins for the branded drug. When the patent protection for the drug expires, a generic drug is usually developed and sold by a competing company. The development and approval of generics is less expensive, allowing them to be sold at a lower price.
RECOUP COST Competition between pharmaceutical companies has resulted in “me-too” drugs, which are defined as chemically-similar compounds or compounds with the same mechanism of action as an existing, approved chemical entity. [20] Much of the “me-too” drug phenomenon is actually a result of independent parallel research at rival companies. [21][22]
It may take 10 or more years for a drug to go from discovery to FDA approval, and if a new clinical pathway is discovered, multiple companies often will simultaneously develop a drug treatment within this pathway, leading to several similar drugs arriving on the market within a short period of time. NOT VERY EFFECTIVE? ELIMINATES MONOPOLY, REDUCE COST, BETTER FOR CONSUMER.
Researchers who have tried to reveal ethical issues with clinical trials, or publish papers showing harmful effects of drugs – and who saw themselves as whistleblowers – have faced or been threatened with lawsuits from drug companies, or have lost their jobs. [31] For example, Dutch medical researcher Dr. Koos Stiekema was sued by the pharmaceutical company Organon for violating his confidentiality agreement, after he discussed his concerns about a clinical trial design with three ethics committees in 1999.
Organon’s other experts agreed that the trial design was safe, and a court in Amsterdam awarded Organon ? 550,000 for the trial-delay costs that resulted from Stiekema’s disclosures. [32] The award was overturned on appeal; the court ruled that Stiekema’s breach of confidentiality was “justified by a higher interest. “[33]
In the United States, corporate whistleblowers are given a percentage of any fines levied UNETHICAL PRACTISE Pharmaceutical sales reps, also known as pharma reps or PSRs, have an excellent understanding of pharmacology – the science of medications and their effects on the human body.
When selling a new product, they must be able to describe its chemistry, method of action, side effects and potential interactions with other drugs. By specializing in a certain group or class of pharmaceuticals such as cardiac or psychiatric drugs, PSRs can deepen their knowledge base, making them more valuable to healthcare providers and more effective at promoting their products.
Most PSRs are salespeople who work on commission within a certain geographic territory. In this role, they schedule and attend sales meetings with health care providers, follow leads and cultivate new customers for the company.
They may also attend industry conferences, speak at provider events and conduct continuing education sessions for medical professionals. In addition to their sales duties, many PSRs conduct field research on behalf of their employers. They may be responsible for monitoring physicians’ prescription patterns or gauging reactions to a new treatment. Reps often spend their evenings and weekends at conferences and networking events where they can develop contacts for future sales.
http://www. innerbody.com/careers-in-health/pharmacy/how-to-become-a-pharmaceutical-sales-representative. html You’ll need at least a four-year degree to qualify for most pharmaceutical sales reps jobs. Often, it doesn’t matter what subject the degree is in, but you may be more attractive to employers with a degree in science. Some companies may even prefer an MBA, since pharmaceutical sales combine scientific knowledge with business principles. http://www. wikihow. com/Become-a-Pharmaceutical-Sales-Rep cost of prescription drugs in us.
Critics of the pharmaceutical lobby argue that the drug industry’s influence allows it to promote legislation friendly to drug manufacturers at the expense of patients. The lobby’s influence in securing the passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003 was considered a major and controversial victory for the industry, as it prevents the government from negotiating prices with drug companies who provide those prescription drugs covered by Medicare. As a result, 61 percent of Medicare spending on prescription drugs is direct profit for pharmaceutical companies.
http://en. wikipedia. org/wiki/Pharmaceutical_lobby influence on doctors The pharmaceutical industry’s sponsorship of clinical research has come under increased scrutiny in recent years, as authors of publications favorable to the industry often receive compensation from major drug companies, thereby raising doubts about their research’s objectivity. Medicare Prescription Drug, Improvement, and Modernization Act The benefit is funded in a complex way, reflecting the diverse priorities of the lobbyists and constituencies whose support was needed: 1.
it provides a subsidy for large employers to discourage them from eliminating private prescription coverage to retired workers (a key AARP goal); it prohibits the Federal government from negotiating discounts with drug companies http://en. wikipedia. org/wiki/Medicare_Prescription_Drug,_Improvement,_and_Modernization_Act Pharmaceutical Research and Manufacturers of America founded in 1958, is a trade group representing the pharmaceutical research and biopharmaceutical companies in the United States.
PhRMA’s stated mission is advocacy for public policies that encourage the discovery of new medicines for patients by pharmaceutical and biopharmaceutical research companies. On its website, PhRMA states its “mission is winning advocacy for public policies that encourage the discovery of life-saving and life-enhancing new medicines for patients by pharmaceutical / biotechnology research companies. To accomplish this mission, PhRMA is dedicated to achieving in Washington, D. C. , the states and the world:[1] 2. “Broad patient access to safe and effective medicines through a free market, without price controls, 3.
“Strong intellectual property incentives, and “Transparent, efficient, regulation and a free flow of information to patients. ” http://en. wikipedia. org/wiki/Pharmaceutical_Research_and_Manufacturers_of_America Biotechnology Industry Organization is the largest trade organization to serve and represent the biotechnology industry in the United States and worldwide;
The Patient Protection and Affordable Care Act consists of a combination of measures to control health care costs, and an expansion of coverage through public insurance (broader Medicaid eligibility and Medicare coverage) and subsidized, regulated private insurance.