US Legislative Bill Research Paper
The key author of this legislation was Royal S. Copeland, a three times Senator from the state of New York. In the year 1968, another aspect was added to this law regarding provisions on the color additives and cosmetics. In the same year, the legislation went further to incorporate Drug Efficacy Study Implementation as a recommendation from the National Academy of Sciences (McNeil, 2001). This body that deals with scientific research investigated the marketed drugs and declared the need for changes.
The Act has been subjected to many amendments, even in the recent years. The most recent amendment has been aimed at fighting against market issues in quality. The Act was established as a reaction to more than 100 patients suspected to get poisoning from drugs in their production. Sulfanilamide as a medication contains diethyl glycol that dissolved the drug to form a liquid (Gross, 1953). Thus, the earlier act of the year 1906 was termed obsolete and was replaced with this new act. The new legislation is concerned with reauthorizing specific programs in the field of Public Health Service and those of Federal Food, Drug and Cosmetic Acts. This is done in accordance with vital concerns on preparedness, security measures, and other purposes. This legislation was enacted by the Congress and the Senate of the United States of America.
This paper discusses legislation in America, specifically the legislation dealing with the strengthening of national response and preparedness for the emergencies in public health. The paper uses this example of legislation to study the national process of creating the bill. The paper discusses the details of the legislation and information pertaining to the process of establishing the bill and those individuals who took key part in it. The paper uses secondary sources of information in forming a credible discussion on the subject. Using reputable books as sources of information for the study gives a reliable basis of understanding.
This Act is popularly known for its use in the process of naming additives of food coloring. An example of this naming is the food color additive called Yellow No. 6. This Act also made the naming of additives in food colors mandatory. The Act emphasizes proper certification of the additives in food coloring. Some of the additives that are being used are regarded as safe and thus do not need to be certified. The Act recognizes nine Food, Drug, and Cosmetics additives that are certified for industrial and domestic use in America. Before being accepted for commercial and local use, these natural and artificial additives and cosmetics had undergone strict scrutiny in assessing their safety for the consumer.
In the era of homeopathic medications, the preparations involved are protected and regulated by the Act. For example, Section 201(j) and 201(g) are concerned with ensuring regulation and protection of this type of medication. The required merit should be that all formulated medications should be matching those listed in America's Homeopathic Pharmacopoeia (McNeil, 2001). The Act recognizes this aspect as the nation's official compendium on drugs.
The process of bottling the water has specific regulations that aid in achieving the needed quality, labeling, and bottling standard. Bottled water undergoes regulations that are similar to those for food. FDA classified bottled water in different categories, like, spring and mineral water (Murcia, 2012).
In the area of cosmetics, the Act looks at cosmetics as beautifying, cleansing, and promoting attractiveness, hence improving appearance. This allows FDA to categorize cosmetic products without the need for regulations. The manufacturers of this commodity are able use raw materials and ingredients; hence, they sell their products without the need for approval from government.
Section 510(k) of the Food and Cosmetics Act says that registration of manufacturers should be submitted to FDA 90 days prior to the process. This registration is required of those entities that have the intention of marketing devices in the field of medication and medical services. This type of notification is called the Premarket Notification. The aim of registration is to allow FDA to assess the device in the market. They find the equivalent of the device in the already established categories of classification. It enables the classification of any new device that is not catered for in the three categories to be identified. The idea is that all devices that reach the market through Premarket Notifications should be equivalent to other devices that were present before May 1976 (Neal, 1996). In case the device does not match any present item in the market, it has to undergo a premarket approval process.
There are three ways in which this devices are categorized in classification. The first class is made up of those devices that do not need the process of clearance or premarket approval. In spite of this, they have to meet the general controls. For instance, a product like dental floss falls under Class I devices in market. The second class of devices is cleared by the process of Premarket Notification. For example, amalgam alloys, diagnostic tests, and devices that are used in filling cavities are put in this category (Bureau of National Affairs, 1964). The device is usually different; therefore, it is necessary to clear those devices that cannot be put in the third class.
The third class consists of devices that have qualified for approval, which is similar to the application of a new drug. The third class devices are considered necessary for supporting human life (Firestone, 2004). They can be implanted in the body of patients or those individuals who desire them. For instance, the most popular device in this group is the automated external defibrillator. In essence, those devices that do not fit in this class are termed as being in the second class.
Those devices that are able to succeed into the market through this process do not undergo an approval by the FDA. Despite this, the devices can be freely sold and marketed on American soil. The common name for them is cleared devices. A published scientific study conducted by the National Research Center for Women and Families showed that those devices that were termed as safety and health hazard for the public in the last five years have been approved through the process of 510(k). This is because the process is less strict and hence cheaper in assessment. For instance, in some cases, devices were thought to be of low risk, so FDA did not have to regulate them (Neal, 1996). The only positive reaction and intended action would be a reevaluation of FDA’s procedures. The action of qualifying devices under a process that is not too stringent is seen as an improvement in the Act.
FDA has worked to reduce the cases of drug shortages. This is an important result as the American market has experienced a significant increase in its provision of drugs to consumers. Obviously, the quality of drugs is a top concern for consumers. The correct approach to the issue can achieve better safety of the drugs, additives, and cosmetics. The federal regulators are strictly supervising drug producers so as to reduce the shortages. The authorities are working closely with health providers and industries to mitigate those shortages (Neal, 1996). Consider a case where the shortage affects the medication that is desperately needed for public health. The result would be increased outbreaks of serious maladies in the community. Producing devices and products that threaten the public would lead to increased deaths and the poorer health of the nation. For instance, FDA says that cases of drug shortages have almost tripled in a period of six years. The number was 61 drug products in 2005, and 178 five years later (Moyers, 2008).
FDA has also sought to improve the situation with Statins, drugs that are taken by patients with fatal diseases and other conditions like heart diseases. This medication has been evaluated in terms of its chemical result by FDA. It has been found that after this medication for lowering cholesterol, the patients should be subjected to liver monitoring. This is because monitoring of the liver enzymes would help in preventing or predicting subsequent liver injuries that come from the side effects of statin. The drug is also known to cause impairment in cognitive skills, like the loss of memory or confusion (Davies, 2007). From the actions of this administrative body, statin and its effects have been monitored, thus reducing subsequent health problems.
In the same area of medication and health care, there has been an increase in the devices for medication. This is because more devices have been introduced to the market through the less stringent process of 510(k) (McNeil, 2001). Many of the devices that could not be approved through the process of FDA have been positively assessed and thus do not need regulations. The health care sector has benefited from more of useful products that suit its needs.
In ensuring quality of products, counterfeiting has been reduced in the national market. This is where non-certified products are brought into the market by individuals who want to take advantage of consumers (Firestone, 2004). Fraud is a serious crime, because ill-intended manufacturers use similar labels to the popular ones to sell fake devices. Moving such devices under the jurisdiction of Food and Drugs Administration, especially in food colors, would put the market in a safer position.
