Facts: Section 3(c)(1)(D)(ii) of FIFRA authorizes EPA to consider certain previously submitted data only if the "follow-on" and registrant has offered to compensate the original registrant for use of the data. The legislation provides for binding arbitration. However, if the registrants fail to agree on compensation, the arbitrator's decision is subject to judicial review only for "fraud, misrepresentation, or other misconduct." The manufacturing firms engaged in the development and marketing of chemicals used in pesticides, appealed the EPA decisions and began proceedings in Federal District Court to challenge the constitutionality of the arbitration provisions. They argued EPA violated Article III of the Constitution by allocating to arbitrators the functions of judicial officers and by limiting
The Case of Neurontin Juan Jesus Lopez RES/351 January 23, 2013 Edward Balian The Case of Neurontin “The goal of ethics in research is to ensure that no one is harmed or suffers adverse consequences from research activities.” (Cooper & Schindler, 2011). In the article of Neurontin written by Dr. Ramirez De Arellano, she discusses the unethical practice of, “selective outcome reporting”, conducted by pharmaceutical giants Pfizer and Parke-Davis. Neurontin, which is the brand name for gabapentin, is prescribed for the treatment of epilepsy. Some physicians prescribe Neurontin for, “off-label”, uses such as insomnia, migraines, bipolar disorder, and restless leg syndrome. In some cases off-label uses often exceed the intended use, which in turn becomes very profitable for the pharmaceutical manufacturer.
The question I ask here today is this ok? Is it ok if these companies are allowed to persuade our doctors to sell us one drug over another? And if so, do we know if our doctors and the sale reps putting our best interests here ahead of their own interest? To better help us to understand a little more of what happens in the Pharma industry, here I have a sample writing from Ben Goldacre new book Big Pharma. Drugs are tested by the people
There are several key actors who can affect the future of RU-486 in the US. President Reagan and his administration, Commissioner Young, and pro-life interest groups do not want RU-486 to be distributed in the US. Pro-choice groups, Roussel and other pharmaceutical companies want RU-486 to be present in the US market. In the long term, the Republican administration and its pro-life allies will want to solidify the FDA’s position on RU-486 making it difficult for opponents to infiltrate the agency’s bureaucratic structure and allow possible approval of the drug. Opponents will want to keep the FDA structure more open, hoping to gain an opportunity for policy change with a shift in political
Both sides are fighting to be right and win. Whether drugs are legalized or stay illegal one or both sides of the argument will be unhappy, unless they come to a compromise. The recent legalization of medical marijuana in some states could be looked at as a compromise. With the compromise, marijuana is legal with the certain prescription, but still is illegal and has repercussions if used for the wrong reason. Another compromise is the decriminalization of marijuana; if someone is to be in possession of less than one ounce then it is just a misdemeanor.
The FDA greatly investigates these companies to make sure that food, human and veterinary drugs, medical devices, cosmetics, and electronic products are safe to sell to the public. If the products turn out to be unsafe, the company will have to announce a recall. In this scenario, the FDA had yet to investigate Pro Health’s new product ProBio. Before then, Pro Health had found out that ProBio had the same brand name as another product already out for purchase. Having the same brand name as another product is also one of the things that are against the FDA’s regulations because this could protect the consumer from buying the wrong drug because of the similar names.
For example of a disclosure that is insufficient is the American Home Products Corp. vs. Johnson & Johnson, it’s a case where Johnson & Johnson advertised its drug by comparing the drugs side effects to other American Home Product drug, but left out some side effects of its own. According to Dictionary.com the Lanham Act does not require full discloser, but the court held the defendant (Johnson & Johnson) to a higher standard and ruled the advertisement misleading because of the potential health risks it posed to
The importance of the blue ocean strategy is that it keeps companies looking for untapped markets, which will provide new goods and services for the consumer. A product or service that might be considered a blue ocean move can be as simple as mixing alcohol and energy drinks packaging them and selling to the public. Anheuser-Busch could do this as long as the energy drinks do not contain caffeine. Mixing alcohol and energy drinks is not a new idea, but in November of 2010 the Food and Drug Administration declared caffeine an illegal and unsafe additive to manufactured alcoholic beverages. So now breweries cannot manufactures energy drinks with alcohol.
advocacy group Mission Possible is leading a campaign to fill a product liability lawsuit with New York and New Jersey residents whose brain tumors may be linked to the consumption of the artificial sweetener aspartame (NutraSweet/Equal/Spoonful, etc.)”. aspartame manufacturers from exposing the public to this sweet poison. In fact, aspartame producers are reporting increased sales and boasting the marketplace addition of 'neotame,' a new aspartame product". Makes one wonder why manufactures still insist in selling this poison. breath mints, carbonated soft drinks, cereals, flavored syrups for coffee, flavored water, frozen ice cream novelties, fruit spreads, sugar free gelatin, iced tea powders( crystal light), juice blends, meal replacements, mousse, no sugar added pies, hard candies, ice cream toppings, no added sugar or sugar free ice cream, non-carbonated diet soft drinks, sugar free gum, instant cocoa powder, pudding, sugar free cookies, fat free, and sugar free yogurt.
The high compensation can cause a bias in the speaker. Sponsoring by the pharmaceutical Industry can bias the results of drug studies. Drug studies, financed by pharmaceutical companies, frequently show positive results in favor of the sponsor. Apart from financing the study, financial links to the authors, such as payments for lectures, may