Merck, the FDA, and the Vioxx Recall In 1999 the Food and Drug Administration (FDA) had approved Vioxx, what would become Merck’s “blockbuster” drug. Although the FDA had approved the drug there was uncertainty of the safety of drug. Vioxx was approved to treat a variety of conditions, such as osteoarthritis and acute pain, but there was also a chance that it would increase cardiovascular problems. What I found most interesting about this case was the changes in how drugs are brought to consumers
Words: 548 - Pages: 3
Prices soar on generics Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 per cent, prompting a backlash from patients, pharmacists and now Washington lawmakers. A Senate panel met Thursday to scrutinize the recent, unexpected trend among generic medicines, which usually cost 30 to 80 per cent less than their branded counterparts. Experts said there are multiple, often unrelated, forces behind the price hikes
Words: 350 - Pages: 2
companies are classified according to their level of investment in Research and Development (R&D): the “Principal Companies” are the companies which have large investments in R&D to produce patented drugs, whereas “Generic Companies” produce offpatent drugs. Generic drugs (Generics or Branded Pharmaceuticals) are defined by Brems et al. (2011) as off-patent drugs which are not offered by the original manufacturer (Principal Companies) and under different brand names, and they represent a substantial
Words: 4085 - Pages: 17
Generic Prescription Drug Costs Prescription drugs have been causing problems in the United States for a very long time. Pharmaceutical companies are one of the largest profiting global industries. It was in 2009 when drug shortages increased with numbers reaching what many have termed crisis level which raised all prices of generic prescription drugs significantly (Fox, Sweet, & Jensen, 2014). This increase was and still is leaving patients with a life threatening decision; either go on
Words: 3188 - Pages: 13
expensive clinical studies and the barriers to market access. Unlike chemical-based prescription drugs, biologic drugs are derived from living cells. They are used to treat cancers, immunological diseases and other chronic illnesses. Biosimilars are generic versions of biological drugs that are similar to innovative biological drugs. The Patient Protection and Affordable Care Act (PPACA) became law in 2010. Section XII of the law allows an abbreviated approval pathway for biosimilars. FDA is currently
Words: 1491 - Pages: 6
Federal Trade Commission announced that Watson Pharmaceutical Inc. proposed a $1.7 billion acquisition against rival generic drug company Arrow Pharmaceutical owners by Robin Hood Holdings Limited. Watson alleged that the transaction would substantially reduce competition in the U.S. markets for important generic drug Cabergoline used to treat Parkinson's disease and generic drug Dronabinol used to treat side effects from chemotherapy. For the commission to be satisfied, the two companies
Words: 638 - Pages: 3
practices. One, called parallel importing, allowed importers in South Africa to purchase drugs from the cheapest source available, regardless of whether the patent holders had given their approval or not. Thus South Africa asserted its right to import “generic versions” of drugs that are still patent protected. The government did this because it claimed to be unable to afford the high cost of medicines that were patent protected. The other practice, called compulsory licensing, permitted the South African
Words: 1709 - Pages: 7
the word because this period is limited in time. It is perhaps better to describe it as a limited warranty. There are also other limitations. Pharmaceutical companies in some countries may not respect intellectual property and may copy or produce generic drugs even before the patent expires. An important criterion of a monopoly is price control. However, in many countries, a governmental agency is responsible for setting the prices of drugs, making the influence of the manufacturers somewhat limited
Words: 858 - Pages: 4
MBA502 Economic Theory and Applications: Chapter 8 Applicable Questions (Pg: 220): 1) Find and label the monopolist’s profit-maximizing output and price: The chart shown below represents monopolistic competition, short run. P MC P1 MR D
Words: 605 - Pages: 3
players; 1000 smaller companies - focus: pipeline – new drugs in the process of development - 15% of sales into R&D - generics: 20-30% decrease in price after patent expiration - GENERIC DRUG COMPANIES: o majority of revenues from selling generic drugs + generic active pharmaceutical ingredients (APIs) o sell packed version of the drug under own name or o sell generic APIs to other pharmaceuticals – package and sell o strict regulatory approval o success: low-cost production capabilities
Words: 806 - Pages: 4
