Regulatory Processes and Administrative & Health Law

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Table of Contents

Abstract
Introduction
Major Responsibilities of FDA:
Departments of FDA
Limitations
Conclusion
References

Abstract

It is in the major responsibilities of any government to take a good care on the issue of Public health and safety. It is one of the essential functions for any government. Food and Drug Agency is responsible to maintain the over all health and safety measure through out the country. Due to diversity in the function of FDA is further divided in to different sub agencies and these sub agencies exercise the power on behalf of FDA. Food related and medicine related work is not as easy as it seems. Especially the medicine sector is much more diversified due to the rapid technological development in the field of medicine and especially in Bio Tech medical world. FDA is still aiming to provide the best safety and security standards by using its full power to maintain the over all public health throughout the nation.

Introduction

In every human society there are some basic life standards and ways of living. These sets of predefined ethical values are called rules. These rules and regulation are the essential elements to build any human society. These rules and regulations are mandatory to maintain the discipline and to build a healthy environment for the development of the society. In every society there is an authority that is responsible to maintain these rules and regulation in the society. This authority is called government. The application of the word Government is quite broader. Government is the authority which maintains the overall development structure of any society or country. This is also the responsibility of the government to provide every available facilities and benefits to their peoples or to the participant of society in against of restricting them in rules and regulation. Government appoints its executives in the practice of distribution of power to perform different functions to maintain the discipline in the society. These subagent of government are called it agencies. Normally a regulatory process in any field initiate with the proposed observation in a specific field. Then this proposed regulation come in to the phase of legislation. Where legislature members argue regarding different aspects of the proposed regulation and then this legislature approves this final regulation and implement it throughout the country. After passing the regulation the government usually announces an organization to maintain the supremacy of the approved rule or regulation. These agencies or authorities have the responsibility to implement that rule or regulation in to the country. That’s why most of the time these nominated governmental organization is called regulatory authorities. If we define regulatory authority than it means an organization appointed by the government to implement some specific tasks and goals for the betterment of any sector is known as the regulatory authority. For this purpose government authorize the organization to take full measure use of its autonomy and exercise its powers to implement the designated rule or regulation. In other words the major function of a regulatory agency is to implement the government’s wants in any specified field. In any regulatory agency there must be some fundamental predefined terms and conditions on which that organization perform its daily operations. This kind of administration is necessary in any regularity authority to prevent the officials from exercising their power negatively. These set of rules are necessary to streamline the operation of the authority. It is also interesting that the authority define its internal rules by itself. Government normally gives full autonomy to these regulatory authorities for two main reasons. First and the most important reason is to give access for restricting the society from committing that act and second one is to take some relax in a specific field. (Regulatory Agency, n.d.)

United States Drug and Food Agency

Such like other regulatory agency U. S Drug and Food Agency is also performing its task in the field of food and drugs. It runs directly under US Department of Health and Human Services. The major purpose to establish this agency is to implement the rules and regulation regarding the public health issue of United States. The major responsibilities of FDA are to protect Public health by taking action and assure the safety, efficiency and securing human and veterinary drugs. FDA is also responsible to take after the process and maintain the integrity of biological products. FDA also has the major role in providing quality food supply in respect of providing strict safety precaution. FDA also helps in process of efficient, safer, affordable medicines and food by providing scientific and technological advance facilities to the companies who shows their interest in developing quality food products. FDA also helps those companies and organizations who wanted to promote more safer and valuable solutions to both human and veterinary problems. FDA also plays an important role in promoting cheaper and quality medicine. Its major role of application is in safety measures and super visioning is its secondary services. (FDA organization, n.d.)

Origin of Food and Drug Agency:

Food and Drug Agency was formed actually in Department of Agriculture, and became an effective part after 1^st July 1930 under the Act of Agricultural Appropriation Act. Before the formation of FDA there were 2 different agencies in department of Agriculture the first one was the Division of Chemistry and the second was Bureau of Chemistry. After following different phases of development like in 1953 FDA was a part of Department of Health, Education and Welfare by Reorganization Plan No. 1 of 1953, effective April 11, 1953 and then transferred to Public Health Services in 1968 by HEW reorganization plan, effective July 1, 1968 and finally it was become the agency of Department of Health and Human Services by Department of Education Organization Act (93 Stat. 695), October 17, 1979. (Matchette, 1995)

Major Responsibilities of FDA:

If we summaries the major responsibilities in different fields then FDA perform duties in

Biologics

In this FDA is the licensing authority for product and manufacturing. FDA has a predefined procedure for the licensing process. FDA also assures the safe blood supply throughout the country. For that purpose it has been regulated that without the approval of FDA, no hospital or medical services provider transfuse or even transfer the blood but only by following the predefined procedure developed by FDA.

Cosmetics

FDA also has active parts in cosmetics in term of safety and labeling to provide quality cosmetics and to prevent from any skin disease. Although it seems quite unusual but FDA also have a supervisory role in the cosmetic industry.

Drugs

Food and Drug Agency is the main authority to give approval of new medical products. FDA also provides advanced research facilities to pharmaceutical industry for the betterment of drugs and medicines. It is in the regulation of drugs that the contents in any medicines should be highlighted on the cover of the drug. Along with that FDA also form, terminate and modifies different drugs standards. Or in other words FDA is the final authority to give the basic structure and guidelines to the local pharmaceutical industries.

Food

Like the role of FDA in the drugs in food sector it is also in the jurisdiction of FDA to make sure that the content of any food is mention on the top of the packing of each and every item food item. Now Natural Drinking water in purified form is in the top priorities of every person that’s why Food and Drug Agency also plays a supervisory role in providing safe and secure drinking water in term of providing strict and regulation for bottled water distribution companies.

Medical Devices

Food and Drug Agency also manage and give license as well as pre market approval of new medical related devices. Due to the rapid technological changes the bio tech industry is going very rapidly. Several different new devices related to the technological cure is coming out day by day. Now it is must for any bio tech instrument provider to take pre marketed approval from Food and Drug agency regarding its product. It was necessary because although the integration in technology is very obvious but it definitely have some negative points as well that’s why FDA make sure that the device which will come after the approval must comply with the basic safety standards of the society and must comply with the basic industry rules. Again like other scopes FDA also responsible to maintain the standards as well as redefine for the betterment of the biotech industries. Another important function of this regulatory authority is to collect the information regarding the malfunction of some pre approved bio tech devices and follow the trails and trace the error regarding the adverse effect of that specific device. This can be called as the tracking system of FDA regarding electronic equipment use in medical field.

Radiation – Emitting Electronic Products

FDA also have the authority to define the safety standards regarding the use of some electrically charged radioactive and wave related items like microwave ovens, television trans – receivers and other diagnostic equipments that are being used in normal human living. FDA also regulates regarding X – ray equipment and cabinet x – ray system which are being used in several airport. Mammography effects are also in regulation of FDA. FDA also defines the safety standards while working with these devices.

Veterinary

Food and Drug Agency also concerns with the live stock feed to provide a safe and quality marked food for humans. Food and Drug Agency also provide technical help and other technological facilities to the farmers to maintain the healthy environment for their livestock in order to provide best care for both human and animals. (What FDA Regulates, n.d.)

While talking with William Hubbard, an FDA Official he informed us that the role of FDA in Food and medicine is quite mandatory, he gives an example that most of the food products it is impossible to avoid foreign ingredients and we are here to make sure that these foreign ingredients are safe enough to be used in our products. For that purpose FDA have a set of procedures to be follow. First FDA took a sample of 3 different sample sizes. Then these samples transported to the main research facility which is at CFSAN. Then we first observe its physical presence and their attributes. After physical we have to analyze the chemical attributes of the sample. William Hubbard also inform that after doing the chemical analysis a concise report is made and presented to the first advisory committee of the FDA then after a process of around 2 days when the sample report become more logical the advisory committee issue an advice or NOC to use the sample product or ingredient in United States. William Hubbard also informed us that for the purpose of inspection FDA have a network of inspection team as Drug and Food Inspectors. Their basic work is to examine the products or any ingredients of the product. They first inspect the container contains the sample then they collect the samples from the container. According to the William Hubbard the main reason behind the delay in the issues of NOC to foreign products and ingredients is insufficient numbers of food inspectors. That’s why it took that much long to process a case. William Hubbard argued that if the numbers of Inspectors increased then they will get their best performance even they will be enable to complete the process in a day. In case of Chinese products like melamine utilization William Hubbard uncover the truth that the level of toxic melamine is much higher in most of the products coming from chine. According to him because of the availability of cheap labor, and cheap raw material third world countries they will be able to produce a product cheaper then us. In that process they usually avoid the basic safety standards in manufacturing these food or food ingredients. According to William Hubbard FDA has an effective media management committee to look after the matters of Public issues. He informed us that FDA has established a new process of regulating foreign items and products. Basic medium to interact and aware the public is mass media campaigning. He informed us that the procedure for implementing some specific regulation is now becoming simpler. According to him FDA has a team of well organized team of Professionals for their public relations. According to William Hubbard FDA is now running its own mass media awareness campaign in digital mediums such as on World Wide Web. FDA has their own media managers to publicize the periodicals and general publication such as weekly bulletins and approval notice along with certain disclaimers and warning. FDA is now on the project to implement a complete sectional list of entities for future references. (Major Flaw in Chinese Melamine Crackdown, n.d.)

Departments of FDA

With reference to the diversified functioning of FDA this organization is further divided into other sub department. Every department covers a specific part of FDA and in the whole FDA uses its sub agencies to run the affairs of the organization. In real this further distribution of FDA is very useful and it is in accordance with distributing system of organizations. These departments provide and exercise their powers in their specific sectors. These departments are:

Center for Biologics Evaluation and Research (CBER)

This is the department for upcoming bio – molecular products. It has been funded about $40 billion dollar for that research. It is responsible for the development in cellular replacement therapies, organ replacement treatment of animals, Molecular research in blood and blood products. This centre regulates the affairs regarding blood transfusion and blood related products like plasma, blood derived proteins and even to manage affairs of blood donors. These agents are supposed to fight with the cancer. This centre I also associated with research of gene therapy to cope the problems by converting abnormal gene of any cell in to normal gene cell. Another new field of work for CBER is the transplantation of different organ or cells from any animal to any human (4cber, 2002).

Center for Devices and Radiological Health (CDRH)

This center is associated, as showing from the name, with the impact of using bio tech instrument in medical field. There are around 20000 firms which are associated to provide different biotech products. This Centre regulates the law and assures the safety by using any new bio – tech device. For any new product this centre has a series of test to analyze the performance of that specific device as well as its after effects. Regulation regarding Radiation also comes under its jurisdiction. This centre also tests any upcoming bio – tech device before launching the specified product into the market. This centre also provides the advanced facilities for research in different emerging technologies like human genome project and radiation safety issues regulation and standards (5cdrh, 2002).

Center for Drug Evaluation and Research (CDER)

The main purpose of this centre is to provide the services to make sure that all the legal medicine and drugs are safe and effective for the peoples of the state. The main regulatory function of this centre is to exercise its power in distributing effective, economical and safe drugs. Even after that this centre watches the medicine market, looking for the sake of some discrepancy. This centre has also the responsibility to monitor the advertisement of the drugs and assure this thing that the advertised product really have that power as shown in the advertisement. Center for Drug Evaluation and Research also provides and promulgate the information with the helps of consultant and health professionals to build a public awareness regarding the use of safe drugs. Efficient Risk Management, Patient and Consumer Safety in using medicine, better consumer Information regarding the medicines and preventing against medicine counterterrorism are some of the main strategic motives of Center for Drug Evaluation and Research (3cder: secured, 2003).

Center for Food Safety and Applied Nutrition (CFSAN)

As shown from its name this centre is associated to provide the standards as well as to test some new product before allowing it to enter into the market. This centre has developed a complete system to test any new product. It is also responsible to take a good care of the food product which are already in market and are in use of peoples (2cfsan, 2002).

Center for Veterinary Medicine (CVM)

The centre for veterinary Medicine has the responsibility to help consumers regarding the idea that the animal food product is safe. This centre is like a safe guard for the betterment of the live stock position. This centre also has the facility to test any veterinary medicine as well as to allow some new medicine to enter in to the market. This center is also committed to provide a complete solution against med Cow Disease. Another important centre which runs under FDA administration is Centers are National Center for Toxicological Research (NCTR). This centre provides the advanced research facilities for toxicological research. This centre regulate regarding the handling and usage of toxic material and their disposal (6cvm: secured, 2002).

Limitations

When talking about the rules and regulations whenever some regulation applies then this creates a form of resistance in those who usually follow the rules. Although FDA work just directly under department of Health and Human Services but on the contrary there are some problems and some limitations like any other department. These are

First of all although FDA can have a close over watch on all advertisement related drugs and medicines but it can only monitor it. Other than that if FDA found some misleading in some advertisement of any medicine it can only inform the trade commission regarding it but it can’t block the advertisement.

Alcohol

Such like with the case of Alcohol. Food and Drug Agency have no active regulatory role in labeling and maintaining the quality of alcohols and beverages.

Consumer Applications and Products

Food and Drug Agency although have regulatory power in consumer products but only in those products which are some how related in emitting or associated with radiation. Otherwise FDA doesn’t have that jurisdiction to restrict access of some product.

Abuse of Drugs

FDA doesn’t have the jurisdiction to work on illegal drugs like heroine and marijuana. This work is for DEA (Drug Enforcement Administration). In fact FDA provides any possible assistance to DEA in order to cope that drugs problems.

Health Insurance

FDA has no active regulation regarding health insurance and health care products or procedures. Reimbursement for medical facility availed doesn’t come under the jurisdiction of FDA. It is related to Centers for Medicare and Medicaid Services.

Meat and Poultry

Although meat and poultry are also in food items but Food safety and Inspection Service has the authority to provide over watch on it. It is not in the jurisdiction of FDA.

Pesticides

All the pesticides are above the jurisdiction of FDA but FDA works with the cooperation of USDA and Environmental Protection agency to prevent the society from the contamination.

Water

All this issues related to this is divided into FDA and Environmental Protection Agency. In a manner that EPA has the responsibility to maintain the supply of pure and safe natural drinking water and FDA has the regulatory power control the labeling and safety of Bottled water. (What FDA does not regulate, n.d.)

Conclusion

Whenever a government wanted to implement some specific restrictions or wanted to achieve some new targets, the government normally appoints an organization to look after the matters by giving this organization the full authority to implement that specific task or plan with full exercise of power. This is the main function and parameter of any regulatory agency. Like other regulatory agency Food and Drug Agency was also working as an autonomous regulatory body in food ad drug services. Its major function is to implement the parameter of public health by a complete over watching and making sure to deliver safe, effective and economical food and medical items. FDA also provides technological help and other research work facilities in almost every part of Food and medicine from meat and Poultry till the use of artificial intelligence in Bio technology. FDA consists of different centers. Each center is associated with some specific research work. FDA is the main Agency that deals with over all public safety standards and food related policies in any manner like food, poultry, meat, bio tech or even labeling is in the regulatory issue of FDA.

References

2cfsan (2002)
3cder: Secured (2003)
4cber (2002)
5cdrh (2002)
6cvm: Secured (2002)
FDA organization (no date)
Regulatory agency, regulatory agencies (no date) Web.
Robert Matchette, Records of the food and drug administration (1995) Web.
What FDA does not regulate (no date)
What FDA regulates (no date)
Major Flaw in Chinese Melamine Crackdown.

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