Marketing Drugs For Off Label

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

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.”

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

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.

These ads are necessary so that the development of new, life-changing drugs are able to occur. At what cost, though? DTC prescription drug ads are being promoted before long-term safety information is known. Vioxx, a pain medication, was advertised and prescribed for five years before being withdrawn from the market for causing strokes and heart attacks; “Vioxx was listed as the primary suspected cause of death in 4,540 mortalities…” (paragraph 7).

Washington, H. A. (2011). Flacking for Big Pharma: Drugmakers Don't Just Compromise Doctors; They Also Undermine the Top Medical Journals and Skew the Findings of Medical Research. (cover story). American Scholar, 80(3), 22. Retrieved from EBSCOhost.

In most cases, there is a committee that decides this. The committee typically includes both physicians and pharmacists. They meet periodically to update the drug list in order to keep it current and relevant.

The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.

Pharmaceutical companies use direct to consumer advertisement to present their drug as effective by means of promotional visuals, symbols and language that appeal to women and attract a large customer base. I want to know if women are the targeted for prescription drugs on television commercials, video commercials on the internet and magazines, also known as in direct to consumer pharmaceutical advertisement. If so, I would like to see the effects this has on not only women but the public’s perception of women and pharmaceutical drugs that treat diseases, specifically mental health diseases.

Another question we come across in this case is "Should these pharmaceutical companies have a moral obligation to make the drugs available to the people who they performed clinical trials on?". Again we clearly should see that the pharmaceutical companies should allow the access of these drugs to the people that are being used to test their products. There is a huge risk for these people who are taking a new drug, not knowing exactly what the outcome can be and are merely treated as guinea pigs for the

The pharmaceutical industry confronts several dilemmas every year. Most of these dilemmas revolve around money or whether or not to sacrifice now for a bigger payoff in the end concerning money and/or lives. Pharmaceutical companies tend to use shortcuts that create ethical problems. Drug companies have spent millions/billions of dollars in research, and they obviously want to see

Pharmaceutical companies and manufacturers are some of the most reported on entities in the world. With many recalls and promotional commercials, scandals, conspiracy theories and research studies, there is never a dull moment. Since the pharmaceutical industry is directly connected to the health of most humans and even other organisms on Earth, the industry gets a lot of widely spread press in various forms when something negative happens. In order to deflect the negative press and keep it from affecting their stocks, most pharmaceutical companies are quick and successful at maintaining a positive reputation and diverting attention with positive narratives that compete with and overshadow the negative press.

Pharmaceutical companies should attempt to be as transparent as possible when marketing prescription drugs to the public. Their marketing efforts should not only convey the benefits of the prescription drug, but also easily convey the possible risks associated with the prescription drugs. Many patients may tend to think the benefits outweigh the potential risks of prescription drugs and may pressure their physician to prescribe it. Due to the way the prescription drug is marketed, the consumer may believe the

A Generic drug (generics) is a drug product that is comparable to a brand/reference-listed drug product in dosage form, strength, quality and performance characteristics, and intended use. These are produced and distributed without patent protection. The Generic drug must contain the same active ingredients as the original formulation. Generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. Most of the generic products are available once the patent protections afforded to the original developer is expired, when it happens it often leads to substantially lower prices for both the original brand name product and the generic forms. Drug patents in US give twenty years of protection, but as they are applied for before clinical trials begin, the effective life of a drug patent tends to be between seven and twelve years.1