Off-Label Lawsuits In A Pharmaceutical Company

Corporate governance: “The set of laws, policies, incentives, and monitors designed to handle the issues arising from the separation of ownership and control.” (Cornett, Adair, & Nofsinger, 2016, p. 16).

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.

Corporate governance in itself has no single definition but common principles which it should follow. For example in 1994 the most agreed term for corporate governance was “the process of supervision and control intended to ensure that the company’s management acts in accordance with the interest of shareholders” (Parkinson, 1994)1. Corporate governance code is not a direct set of rules but a self-regulated framework which businesses choose to follow. This code has continued to change in the past 20 years in accordance with what is happening in the business world. For example the Enron scandal caused reform in corporate governance with the Higgs Report which corrected the issues which were necessary. Although it does not quickly fix problems, it gives a better framework to

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.”

As details of the Enron scandal surfaced public outrage grew, calling for action, accountability and consequences. Corporate governance began receiving renewed interest. Corporate governance is a multi-faceted subject that sets forth the rules and responsibilities of the relationship between the corporation and its stakeholders (Cross & Miller, 2012). This includes the company’s officers and management team, the board of directors, and the organizations shareholders.

The Brazilian pharmaceutical market is the ninth largest in the world and the second among the BRIC countries (First is China, with Russia and India occupying third and fourth), annually handling about R $ 28 billion, a growth trend. Among the six largest pharmaceutical companies in the world, four are Brazilian. Currently there are about 540 pharmaceutical companies registered in Brazil.

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.

On the other hand, although such drug companies may be acting unethically, they are also acting in a legal matter. In other words, they are

Another striking example of this regulatory failure and the unethical outcomes of regulatory capture is the use of trade secret laws to benefit drug companies and help them minimize, deny, or hide adverse effects of their products. The lack of transparency in the drug approval process is highlighted by the use of trade secret laws, which are successful at hiding unflattering drug trial data or reports of dangerous side effects even against the Freedom of Information Act by classifying them as “trade secrets” instead of necessary information for consumers. In the private sector, trade secret laws are a fundamental protection to drive investment and economic growth, however, when interpreted generously, this law protects all the data collected during the innovative period of drug manufacturing, including the results of some trials or side effect reporting, from anyone outside the company. Supporters of this interpretation of the Freedom of Information Act claim that failed efforts at drug development need protection to ensure that the developers are not at a “competitive disadvantage.” However, when the same drug can be disapproved for one use but approved for another, this data is still relevant to public health, yet is locked up by the FDA. This was the case for the Eli Lilly drug Yentreve, a drug that was disapproved for treating stress urinary incontinence due to data showing its connection to suicide rate increases, but approved under the name Cymbalta to treat depression. According to the FDA, federal regulation prohibits them from releasing study data for a drug that failed to gain FDA approval, even if the same drug under a different name, is on the market. With so much data off-limits, it is hard to account for other cases such as this but many private researchers point to pain reliever Bextra, manufactured by the

Over the past couple of decades, a sudden change has started to take over the way business is done. The time when no rules applied, and anyone could do what they pleased at the cost of others or the environment is rapidly ending. Instead, companies today have become aware that it is essential for them to employ ethics and morality in their actions, if not they will be heavily scrutinized and rejected by the public. This way of thinking also applies to the pharmaceutical industry, which over the past century has been rapidly expanding. Do to the fact that this industry can determine the health and lives of millions of people, it is imperative that this industry follow an ethical and moral path.

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.

For CVS’s legal concern, not only do they have to follow federal and state guideline for employees, they have to follow federal guidelines for pharmaceuticals, legal requirements for their nurses, doctors and pharmacist. In addition CVS is expanding into global markets, and that opens them up to foreign legal requirements. Socially, CVS Caremark has a long-standing track record of sound corporate governance and stands firmly committed to acting with integrity and holding

Society expects drug companies to improve people’s well-being and to behave like a nonprofit company not overly concerned with making large profits. However, investors

Pharmed First Inc. is a widely successful chain pharmaceutical company with 85 drugstores located in Canada’s Atlantic provinces. George Brenner is one of the 6 regional managers and Angela MacFee is a store manager in a mall located in Dartmouth. One of MacFee’s loyal customers have purchased 9 packages of Diet Magic on September 2011 however wanted to return them on May 2012. Subsequently, MacFee reacted hastily and defensively, arguing with Johnston in spite of Pharmed First Inc. return policy (Figure 1). As a result, Johnston wrote a letter to Frank Chen, the president of Pharmed First Inc. and told Brenner to deal with it. He proposed that the company gives Johnston a $500 voucher and that MacFee apologizes. However, MacFee remained inflexible as she also challenged Brenner’s authority.

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