Abbott and Merck - Essay Example

Abbot and Merck are both pharmaceutical companies which are those companies that make a commercial business out of researching, developing, and selling drugs that cure or help in curing various ailments. They can create medicine that is generic or branded in nature therefore they use patents and other industrial rules to ensure that the business remains competitive. However, because they are deeply connected with the issue of healthcare and public services, they are often regulated in most countries by the respective authorities of the government that deal with pharmaceutical companies.

In the United States, there are several regulatory bodies that such companies would have to deal with. While their financial operations as well as advertising methods are regulated by other bodies, even their basic operations of researching and producing medicine are heavily regulated. The Department of Health and Human Services, Food and Drug Administration, National Institute of Health, Center for Disease Control, and even the National Science Foundation can have an impact on how pharmaceutical companies operate (DHHS, 2007). At the same time, some organizations have more regulatory control than others.  

For example, the FDA is one body that has the most control over regulations that can force pharmaceutical companies to operate one way or the other. The FDA comes under the Department of Health and Human Services which gives the FDA broad guidelines to follow. The FDA is the actual authority that makes the rules that drug companies have to follow. These regulations impact much more than medicine since food, dietary supplements, cosmetics, medicinal products for use in health care as well as medical implements are regulated by the FDA (FDA, 2007).

For pharmaceutical companies, the basic regulations start from food and dietary supplements that may be produced by these companies such as Vitamin C tablets or folic acid pills that may not require prescriptions in many cases. However, in many cases, these products may be treated as food in which case there is a strong labeling requirement of the FDA which regulates the producers as to what information needs to be on the packaging of the product (FDA, 2007).

For example, as an industry regulation, the producers of dietary supplements are allowed to make claims as to the benefits of their products but they cannot make a claim that their supplements can prevent or cure a disease. At the same time, supplements are not heavily regulated and action against the producers of supplements can only be taken if the product is proven to be harmful after it has been released to the market (FDA, 2007).

More importantly, companies like Merck and Abbot continually deal with the FDA’s Center for Drug Evaluation which is responsible for evaluating new drugs that come from the research labs of these companies. The center ensures that the drugs being produced actually do what they claim to do and remain safe for human consumption. This center also oversees the manufacture of the drugs and gives its approval for a drug when it has been found to be beneficial for the patient while the health risks associated with the drug are minimal (FDA, 2007).

The regulations prohibit any drug company from marketing or providing a drug that is under scrutiny by the FDA and even after approval, the drug may not be sold for purposes other than for what the FDA has approved its use. The burden of proof for the drug is effective and safe is on the drug company which is supposed to conduct its own trials and submit the comprehensive results of these trials to the FDA (DHHS, 2007).

The regulations for such trials and the overall process of approval are conducted by professionals recruited by the FDA and these include physicians, statistical analysts, pharmacists, and other government regulators. The FDA is also authorized by the government to make spot checks of the pharmaceutical companies manufacturing facilities to judge if the production of medicine is following the applicable rules and regulations. If these employees consider anything amiss with the production or if they think that the drug is not suitable, they can always deny approval for the production or the marketing of any given medicine (FDA, 2007).

On the other hand, a drug that is found to hold some promise for the treatment of a disease can be given the status of an approvable drug that may be approved if certain conditions are met or if the objections raised by the FDA are handled effectively by the pharmaceutical company (FDA, 2007). There may be one or more approval cycles before a drug is finally given the approved status with which the pharmaceutical company can start manufacturing and selling that drug to the public at large.

On the other hand, there can be drugs that need to be given to the public quickly since they could be potentially lifesaving for diseases that have no real cure. In such cases, the FDA can put the drug on the path for accelerated approval (FDA, 2007). For instance, if a new drug was shown to reverse lung cancer in clinical trials then the FDA may put that drug under an accelerated approval process to get it faster out into the market.

In conclusion, companies such as Merck and Abbott have a lot to do with regulatory bodies but their main concern remains with the FDA under the Department of Health and Human Services (DHHS, 2007). While the FDA regulates drug companies, it also seems to appreciate the input given by these companies and their usefulness to the field of medicine. It seems that there is a balancing act that the FDA has to do between what the drug companies want and what the regulations allow them to do but the concern for the safety of the public always remains paramount for the FDA if not the drug companies.