Off Label Promotion : Profitable Health Jeopardizing Act Of Defiance

They have also attacked patent listings in the Food and Drug Administration “Orange Book” and have alleged monopolization through fraud on the Patent and Trademark Office and sham litigation. Yet other cases have condemned distribution agreements as unlawful exclusive dealing. These government actions have led to substantial private class action litigation against the pharmaceutical industry. The FTC has also challenged numerous mergers and acquisitions in the industry over the last decade. One common feature in all of these cases is the need to define a relevant market. In nonmerger cases, the FTC and private plaintiffsgenerally allege narrow markets, limited to a single drug and its generic equivalent in some cases and to generic drugs excluding the bioequivalent “brand-name” drug in other cases. In its merger challenges, on the other hand, the FTC has alleged markets ranging from those based upon a particular chemical compound, to broader markets based upon various drugs’ manner of interaction or dosage form, to still broader markets of all drugs used to treat a disease or condition. In numerous pharmaceutical merger challenges, the government has included in the market not only currently marketed drugs but also other drugs under development, alleging “innovation markets.”

There are proponents of DTC prescription drug ads. They argue that “the ads inform patients about diseases and possible treatments, encourage people to seek medical advice, help remove stigma associated with medical conditions, and provide needed sales revenue to fund costly research and development (R&D) of new drugs (Drug Ads ProCon.org).” On the flip side opponents argue “that DTC drug ads misinform patients, promote drugs before long-term safety-profiles can be known, medicalize and stigmatize normal conditions and bodily functions like wrinkles and low testosterone, waste valuable medical appointment time, and have led to our society’s overuse of prescription drugs (Drug Ads ProCon.org).”

Many consumers are often not aware that a large number of companies do not label everything they put

Bill Maher once mocked the aggressive nature of the drug advertisements that direct you to tell your doctor that their drug is right for you. “Tell your doctor? Shouldn’t your doctor tell you what drugs you need. When you tell your doctor isn’t he just a dealer at that point,” said Bill Maher. The American public generally trusts their government to protect them from the hidden dangers prescription and over-the-counter drugs. However, that trust isn’t fully warranted as the FDA has been featured in the GAO report of “high risk” agencies which need drastic reforms. After all, the FDA is in charge of regulating the shameless drug advertisements that inundate the airwaves.

In 1899, Florence Kelley instigated The White Label Campaign of the National Consumers League (NCL), an organization dedicated to promoting proper working conditions and fair living wages for factory laborers.1 By linking middle-class women reformers with trade unionists in conjunction with the use of labels, the NCL successfully advocated for legislation to establish safety standards and maximum work hours during the Progressive Era.2 The NCL worked to help consumers know goods were produced through consumer sovereignty, which suggests the consumer is the one who can influence the production of goods.3 The White Label Campaign presents the idea that it is the responsibility of the consumer to “demand safety and reliability from the goods and services they buy.”4 In addition, the outcome of this campaign brought awareness to American society during the Progressive Era; this showed that natural human rights are not a privilege, but a right. The purpose of the White Label Campaign was to identify and label goods made under fair living wages and proper working conditions, and to compel consumers to take responsibility to support white-labeled companies.

The article discusses the regulations of the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC) on health claims and structure/function claims of food products. It explains that the FDA approves a health claim that is supported by

Relators brought a qui tam action on behalf of the United States and various states against Solvay Pharmaceuticals, Inc. (“SPI”) and its affiliates pursuant to the False Claims Act. Relators alleged that SPI had marketed drugs for conditions other than the conditions for which the drugs were approved by the FDA and offered kickbacks to physicians who prescribed these drugs. Relators moved for summary judgment on a number of SPI’s affirmative defenses,

Approximately eighty percent of food eaten in the United States contains GMOs, but not many people know what they are actually consuming from their food sources (Prah). Genetically modified organism, also known as genetically modified organisms engineered in a lab by scientists that alter the genes of plants and animals. By fixating DNA from other organisms into America’s food sources, they create substances that are detrimental to the health of human beings. In addition to this, these genetically modified organisms are completely foreign to the plants and animals they undergo; their genes can become damaged from inserting the genes of the organisms. This unnatural process can interfere with a metabolic pathway in the plant or animal. In addition, studies have shown that on average forty-four percent of people had the “Round-up Ready” herbicide, glyphosate, which is used on genetically modified crops, found in their bodies (Stonebrook). Both, the genetically modified organisms and the chemicals used on them, cause several problems to occur in humans and other organisms which consume GMOs. These include tumors, damaged immune systems, allergies, and infertility; this is dangerous to the health of humans and to their regular body processes. Americans have the right to know what is going into their bodies and how these man-made GMOs are affecting them. By the government

According to Ghillyer (2014), medications and drugs have many uses that are often not approved by the Federal Drug Administration. In 2012 Abbott Laboratories were involved in a lawsuit related to illegal marketing. The company promoted a medication to control and treat agitation, aggression, and schizophrenia. The medication had only been approved for treatment of seizures, migraines, and bipolar mania. GlaxoKline-Smith was also involved in a settlement regarding off-label promotions for marketing Wellbutrin for weight loss, sexual dysfunction, substance addiction, and behavioral

In other words, it is like “sell whatever you want, but don’t get yourself caught”. These seems to be so irresponsible especially for profit-driven manufacturers. Furthermore, even though the FDA (in cooperation with the FTC) have already regulate product advertisement, there are still so many false advertising claiming that their product somehow could be used for diagnosis and curing certain diseases. In this matter, we could not give the consumer full responsibility to determine on their own which ones are safe as most of the people lack the related knowledge. In other examples, even though the advertising is ‘properly-written’ and acceptable under FTC regulations, they still provide us with some scientific facts that the products showed indication of diagnostic and curing effects, but even the source-reliability could still be questioned. Nevertheless, most people will still get fooled easily by these claims, especially from products sold online that also provide pictures of random celebrities as if they are consuming these products (in fact they are not!) and/or some un-reliable testimonial photos. Robert Longley from about.com reported that in 2014, the FDA have sent warning letters to 16 dietary supplement distributors that made false and

Understanding the topic of medical fraud and off labeling is important, especially for consumers who participate in the use of prescription drugs. It is imperative to understand what your doctor is prescribing and knowing the specific uses of said drug. Off labeling may occur and recognizing this fact will only benefit a wise consumer and make them aware of the risks of using a drug that was prescribed for a uses not on the label. This topic is especially important during the time of new Healthcare reform. Although it seems like we should be able to trust our doctors and believe what they tell us and the drugs they approve

Overall, the analysis found that 37% of physicians said they sometimes or often agreed to prescribe a brand-name drug at their patients’ request.” Consumers rarely think to give their doctor permission not to prescribe them a drug. The emotional connection and sense of urgency created by advertisements can make patients develop a sense of dependency on the product before even trying it.

For example, Vedula (2012) notes that FDA guidelines state pharmaceutical companies can use peer-reviewed articles to publicize evidence of a drug’s effectiveness for off-label uses, as long as a number of conditions are met—perhaps the most essential of which is that “the information disseminated must not be false or misleading.” However, Vedula continues, there is no unyielding regulation that all research findings have to be published. Therefore, a company can still choose to selectively disseminate favorable findings. His article concludes that there is now a copious amount of evidence that suggests selective reporting of study results, based on the strength and direction of findings, is performed extensively by the pharmaceutical industry.

There is full concurrence among the four commentators: Gamgort, Nelson, Thompson, and Sheehan that Bryant Pharmaceuticals should not approve Laura's pitch for a product placement of Seflex on the news program The Morning Show. Undoubtedly, Laura and her Bryant colleagues, along with executive management have an unenviable task; conjuring a "dramatic increase in sales" (Peebles, Ellen. October 2003 P. 32) of Seflex prior to its patent expiration in two years. Yet, the purported solution fails to address serious concerns across three critical issues: "legal, business, and ethical" (Peebles, Ellen. October 2003 P. 40).

Thinking about the responsibility for illegal off-label promotion, question of the chain of command pops out. Who initiates that type of campaigns and actions? Sometimes it’s company’s established strategy; sometimes it’s sales force’s desire to reach the quota. What happens when company’s ideas confront with common sense and legal responsibilities of the employees? Do they really have a choice?