Premium Essay

Fda to Regulate Drugs

In: Other Topics

Submitted By cmmccann
Words 1260
Pages 6
Mohammed’s part:
What does the FDA do?
FDA is responsible for protecting the public health by assuring the safety and security of human and veterinary drugs, biological products, and medical devices.
FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines to maintain and improve their health.
Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
What does the FDA regulate?
The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction
Drugs, including:
• prescription drugs (both brand-name and generic)
• non-prescription (over-the-counter) drugs
• vaccines
• blood and blood products
• cellular and gene therapy products
• tissue and tissue products

The Federal Drug Act is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world. The law is intended to assure the consumer that drugs and devices are safe and effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive.

Chris’ Part
The Regulation of Drugs
• The first step for a company seeking approval to sell a new drug is to perform laboratory and animal tests to learn how the drug works and if it will be safe…...

Similar Documents

Premium Essay

How Fda Evaluates Drug Approvals

...101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk Shirley Murphy, MD, and Rosemary Roberts, MD Silver Spring, Md A prominently displayed boxed warning, the so-called ‘‘black box,’’ is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and implications of these ‘‘black box’’ warnings. In this review, our goal is to provide insight into how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. We discuss drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in children, and postmarketing safety surveillance. In addition, we encourage health care providers to report drug reactions to the Food and Drug Administration’s MedWatch program. A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted. (J Allergy Clin Immunol 2006;117:34-9.) Key words: Food and Drug Administration, adverse drug reactions, MedWatch, ‘‘black box’’ warning, drug labeling, drug benefit/risk, risk management, postmarketing surveillance, drug development Abbreviations used AERS: Adverse Event Reporting System CDER: Center for Drug Evaluation and......

Words: 5617 - Pages: 23

Premium Essay

Fda Policies

...U.S. Food and Drug Administration (FDA) drug review bears a structural similarity to many decisions made by other regulatory agencies: high uncertainty, low reversibility, avoidance of observable error, and high political stakes that induce lobbying by interested parties. This project explores the policy lessons to be learned from viewing FDA drug review as a politically shaped exercise in information processing. I argue that the incentives facing regulators induce limits on the degree to which drug review can be accelerated, that the same incentives could render privatization initiatives problematic, and that political pressures could play a useful role in identifying priority drugs. Patients, more than pharmaceutical firms, shape the political costs to the FDA of delaying drug approval. Consider two hypothetical consumers, one a pharmaceutical consumer (“patient”) who wishes to try a new drug for some ailment, the other a vitamin consumer who wishes to take zinc supplements to ward off a cold or flu. There are few institutional restrictions upon the consumption decisions of the vitamin consumer, at least in the United States. She is free to purchase vitamin products over the counter, and the vitamin manufacturer is free to sell them without prior authorization or licensing. Not so with pharmaceuticals. The marketplace for pharmaceuticals is one of the most highly regulated industries in the U.S. economy.1 To use any new pharmaceutical product, the patient must secure......

Words: 5125 - Pages: 21

Premium Essay

Fda Approvals for Medical Trials

...Paper FDA Approval process for Clinical Trials If you, or someone you loved, were diagnosed with a terminal disease, would you chance using a non-FDA approved medication to increase your life expectancy? Many pharmaceutical companies have the medication that could save countless lives, but the FDA clinical trials for these medicines are problematic for enrollment, and thousands of patients are often turned down. New drugs are vitally important to improving the lives and health of Americans. Between 1986 and 2000, new drugs were responsible for 40 percent of the total increase in life expectancy. Yet, the FDA’s clinical trial process remains lengthy and expensive. It takes, on average, more than a decade to bring a new drug from the laboratory to the market. Polls show a clear majority of specialists believe the FDA clinical trial process is too slow and most report having been personally hindered in treating a patient due to the FDA approval process. The clinical trial process initiates when a drug developer submits an Investigational New Drug Application (IND) to the FDA. The IND application includes all available data on the proposed investigational drug, including the results of any animal testing. In reviewing IND applications, the FDA seeks to ensure that the proposed trial does not expose patients to “unreasonable risk of harm.” Clinical trials then move ahead in three mandatory human testing phases. Phase I consists of giving the investigational drug to a......

Words: 2316 - Pages: 10

Premium Essay

Government Regulate People’s Choice

...Government Regulate People’s Choice A healthy nation translates to faster growth, productivity, innovation, and other factors that contribute to well being of its people. Therefore, government should prioritize on ensuring it’s nation is healthy. Government reluctance on health issues can cost any nation a fortune. However, government involvement should cover all sectors of the health department. The government should prioritize these sectors, for example: FDA, disease control, and many more. Concerns have been raised concerning smoking, drinking and eating habits as they are the main causes of death in the world today. Diseases related to unhealthy habits like smoking, drinking, poor diet, and GMO’s are rampant in developed countries. While, trying to unearth the truth about unhealthy habits, the ideal posed in this paper has most health professionals and government officers have been struggling to answer. It is morally correct to have the government regulate personal choices on the above raised problems. As mentioned early, mortality rate caused by unhealthy habits is staggering. The leading causes of these deaths obesity and diseases like diabetes, coronary heart failure, and respiratory diseases caused mainly by unhealthy diet, smoking, and drinking (DA and DHHS, 20). Governments are reluctant to regulate personal choices on what one can eat, drink, and smoke. However, there is massive campaign to ensure that people know the health risk related with......

Words: 1133 - Pages: 5

Premium Essay

Fda Standards on Anti-Depressant

...Anti-Depressant Drugs and FDA Approval Anti-Depressant Drugs and FDA Approval Procedure Ashley Jensen A01054823 Pima Community College Psych 101 Abstract Antidepressant drugs fall under three main categories; MOAI’s, Tricyclic Antidepressants, and SSRI’s. Like any drug, Antidepressant drugs must get FDA approval prior to putting in on the market for society, ensuring it has no harmful effects. The Food and Drug Association has a series of trials, tests, and procedures, to ensure these drugs are safe and effective for people with severe depression. Effects of each Type of Antidepressant Drugs Anti-Depression drugs target the amygdala by directly by increasing the activity in the prefrontal cortex, therefore decreasing the reactivity in the amygdala. The amygdala has cortical and subcortical projection to other regions of the brain, such as the hippocampus, which is where we create and maintain memories. With the cortical projections increasing the level of activity for the amygdala, there is a possibility your brain will adapt and sustain a repetitive negative associations when approached with an emotion. Anti-Depression medicines target the amygdala because the amygdala is the integrated center for emotions and an emotional behavior. (DeRubeis, R. J., Siegle, G. J., & Hollon, S. D. 2008). Monoamine Oxidase Inhibitors MAOI’s were the first discovered anti-depressant medicine in the 1950’s, and they were originally used to treat symptoms of tuberculosis.......

Words: 1612 - Pages: 7

Free Essay

Core Functions of Fda

...Thesis: One of the biggest agencies within the U.S. Department of Health and Human Services is the Food and Drug Administration (FDA). The Office of the Commissioner and four directorates administer the core functions of the agency which are medical products and tobacco, foods and veterinary medicine, global regulatory operations and policy, and operations. While being a huge, big named agency designed to protect and provide public health; there are necessary regulations and guidelines to ensure the purpose of the agency is being met. This paper will explore the needs, stakeholders, expected outcomes, and other regulatory action and implementation of the FDA. Introduction: The Food and Drug Administration Safety and Innovation Act (FDASIA) is a regulation which was proposed by The Food and Drug Administration (FDA or Agency) to establish a list of “qualifying pathogens” that are likely to cause serious harm to public health. FDASIA utilizes the agency’s ability to protect and improve public health by giving the authority to collect user fees, promoting innovation, increasing stakeholder involvement, and enhancing the safety of the drug supply chain. Methicillin-Resistant Staphylococcus aureus (MRSA) is a “staph” germ that does not improve with the first-line antibiotics that typically cure staph infections. When this takes place, the germ is “resistant” to the antibiotic. This class of antibiotics includes penicillin, amoxicillin, oxacillin, methicillin, and others. (MRSA...

Words: 2680 - Pages: 11

Premium Essay

Electronic Cigarettes: Regulate Them

...smoke, to the user (Mayo Clinic, 2013). Many of the manufacturers of electronic cigarettes boast the safety of these products although there are little evidence supporting that claim. Nevertheless, people continue to purchase them, and it is important to start implementing stricter policies on them. The Family Smoking Prevention and Tobacco Control Act of 2009 gives the FDA authority to regulate the marketing, manufacture and sale of tobacco products (Products, 2013), but the original intent of the FDA is to regulate electronic cigarettes as therapeutic drug delivery devices because of the contents of the liquid. In 2010 the United States District Court of Appeals declares that electronic cigarettes should be considered tobacco products (Grana, 2013). Unfortunately, since this declaration, the FDA has not exercised regulatory authority over electronic cigarettes. A main reason for this is partly due to the government shutdown in October. Prior to this, the FDA has taken steps to provide a proposed rule to the Office of Management and Budget, which is currently reviewing it (Staff, 2013). In the absence of FDA regulation many states, localities, and the Department of Transportation have enacted their own policies to restrict electronic cigarettes, whether it be the sale to minors or the use of them in public spaces. In a 2010 hearing before the Senate Committee on Commerce, Science and Transportation, Susan Kurland, Assistant Secretary for Aviation and International......

Words: 2323 - Pages: 10

Premium Essay

Fda Roles of Safety for the Public

...The Roles of the FDA in Protecting the Patient Rasmussen College Author Note This paper is being submitted on October 18, 2015, for Trang Nygyen’s PTN1009 Foundations of pharmacy practice. The FDA Roles in Protecting the Patient The current role of the FDA is to protect the public health by assuring the safety, efficacy and security of human and veternariny drugs, biological products, medical devices, our national food supply, cosmetics, and products that emit radiation.(“FDA Fundamentals, 2015”) The FDA serves as a consumer watchdog, making sure that medications are safe and effective to help improve patient’s health. All new drugs are evaluated before they can be sold to ensure they work correctly and the health benefits outweigh known risks. FDA monitors and ensures safety of drugs after approval. (“What is the FDA’s role in drug safety”, 2010-2015) Risk Evaluation and Mitigation Strategy (REMS) is used to manage a known or potential serious risk associated with a drug or biological product. REMS are required by the FDA if determined they are necessary. REMS include Medwatch, medication guide, and black labeling.(“REMS resource center, 2015”) Medwatch is an FDA safety information and adverse event reporting program. The FDA uses REMS by communicating safety information by releasing Medwatch safety alerts to subscribers and through the Medwatch partner program. www.fda.gov/medwatch/safety The FDA posts monthly label changes on the web and distributes......

Words: 530 - Pages: 3

Free Essay

The Fda

...One of the oldest U.S. consumer protection agencies, the Food and Drug Administration (FDA) protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards. As part of the department of health and human services, the FDA annually regulates over $1 trillion worth of products, which account for one-fourth of all consumer spending in the United States. It also protects the rights and safety of patients in clinical trials of new medical products, monitors the promotional activities of drug and device manufacturers, regulates the labeling of all packaged foods, and monitors the safety of the nation's blood supply. To ensure compliance with its regulations, the FDA employs over 1,000 investigators and inspectors who visit over 15,000 food-processing, drug-manufacturing, and other facilities each year. If it finds violations of law, the FDA first encourages an offending company to voluntarily correct the problem or to recall a faulty product from the market. If the firm does not voluntarily comply with the law, the FDA may take it to court and seek criminal penalties against it. The FDA may also seize faulty products, order product recalls, seek injunctive relief, impose fines, and take other types of enforcement action. Each year, the FDA declares about 3,000 products and 30,000 import shipments to be unacceptable in various ways. The FDA employs over 2,000 scientists—including 900 chemists and 300 microbiologists—who provide the......

Words: 3299 - Pages: 14

Premium Essay

Fda Approvals

...Food and Drug Agency’s Drug Approval Process Abstract The drug approval process of the Food and Drug Agency for pharmaceuticals is a complex and often lengthy one. Done out of necessity to ensure the products being introduced into the growing healthcare field are overall safe and effective for utilization by patients. While the process is far from perfect it still a staple in introducing innovative and breakthrough drugs into healthcare fields across the board. This paper will discuss the process encountered to get pharmaceuticals approved for manufacture and distribution to physicians and patients. Food and Drug Agency’s Drug Approval Process “For healthcare technology, the most important regulatory approval comes from the federal Food and Drug Administration (FDA)” (Williams & Torrens, 2008, pg.28). This agency approves all drugs and pharmaceuticals, medical devices, and some medical equipment. The FDA also controls access to drugs by deciding whether a certain drug will be available by prescription only or as an over-the-counter purchase (Shi & Singh, 2013, pg.115). The most well-known regulatory review of medical technology is that conducted on pharmaceutical products and to some medical devices that are subjected to detailed preliminary approvals, clinical trials, and post-approval surveillance policies. Before a drug can begin (first phase) clinical testing, the sponsor of the drug must evaluate the product’s safety and biological activity via in vitro......

Words: 911 - Pages: 4

Premium Essay

Should the Fda Regulate Vitamins and Dietary Supplements?

...Abhitej Nibber YR7544 NEWS MEMO 2- Food Politics Should the FDA regulate Vitamins and Dietary supplements? How healthy are the Vitamins and Dietary supplements that promise to promote good health? Vitamins and other Dietary supplements have no set boundaries since the law that regulates this industry, The Dietary Supplements Health and Education Act of 1994 took the legal control and jurisdiction power away from the Food and Drug Administration (FDA). This law was passed in 1994 by the Congress and signed by the president and resulted in a piece of legislation called the Dietary Supplement Health and Education Act (DSHEA) of 1994.This legislation limits the FDA’s power to regulate dietary supplements. These Vitamins and Supplements have long been known to have potential serious health consequences and can also lead to death. Excess and improper consumption of these supplements can cause Liver damage, reduced bone strength, Cancer and cause birth defects. Excess of iron may lead to vomiting and nausea, harmful during pregnancy and nursing, harmful to children, increased risk of high blood pressure, heart attack, stroke and various other cardiovascular problems. The safety and health is endangered by the unregulated dietary supplements, but the dollars the industry is spending serves to dampen congressional concern over the issue,” said Ms. Sloan.  “Heartbreakingly, this kind of money spending is highly usual as it has a great impact.  Industries facing a......

Words: 782 - Pages: 4

Premium Essay

Fda Research Prospectus

...Food &Drug Administration (FDA) IT Security Project Plan ITEC640-9043 October 14, 2015 Table of Contents Introduction…………. …………………………………………………………………Page 3-4 Project Organization…………………….……………………………………………....Page 5-6 Statement of Need ………………………………………………………..…………….Page 7-8 Project Definition ………………………………………………………………………Page 8-10 Approach to Developing Project Plan………………………………………………….Page 11-12 References………………………………………………………………………………Page 13 Introduction Green Team Consulting Company is a team of professional project managers, who are hired to assist organizations with known network integrity issues after a cyber attack or data breach. The Greet Team is an investigative firm that specializes in a high quality, detailed analysis of the breach, development of a project mitigation plan, evaluation of any legal implications that may result in the future, and implementation strategies of new systems and workflows that will ensure future network security. Walter Harris, the Chief Operations Officer of the Food and Drug Administration or FDA, has contracted with the Green Team after a critical data breach that exposed confidential information. The data that was exposed includes but is not limited to: employee records, new pharmaceutical drug proposals, clinical trial results, and complaints filed about products the FDA regulates. The three main goals of this project will be to target the cause of the data breach, review the consequences this......

Words: 2776 - Pages: 12

Free Essay

Memo Fda

...this chain of event FDA is also being dragged since FDA did not pass the Original Tracking Bar rule. A lot of people are saying that FDA is responsible for these, although it is clear that FDA does not have any liability towards the these victims. Robins and Robins has caused this problem and they were one of the most active members who opposed this regulation and even bribed companies to be against it. they went ahead and they convinced the addicts to support them. Robins and Robins lobbied against this rule and got the rule stopped during the public comments period. Even after Robins and Robins was aware of the problem caused by their medicine they did not make a justified effort to recall their product. It could never be a 100% recall since there is no tracking methodology that can be used. As far as the role played by FDA is concerned they did the right thing in stopping this bar code rule. They could not pass it without public’s consent and majority of them had voted against it. They thought it would violate their privacy rights. And also doing this would have increased the price of the medicine which was a big concern. As it is hard for people to afford medication as is and with this the price increase would have been tremendous. It was not only Robins and robins that lobbied against it but there were certain public interest groups involved as well. The death and illness have been caused because of the negligence of Robins and Robins and not the FDA. In response......

Words: 523 - Pages: 3

Premium Essay

Fda Proposals

...Britney Brooks Week 2 Assignment Food and Drug Administration – This agency interests me because I do cook, and knowing about certain foods and the benefits/risks of those foods, will factor into my eating habits for myself and my family. This will affect me directly as it could lead to a change in the foods I choose to cook and eat. 2. Describe the proposal/change.  The proposal will allow the FDA to collect information from a study about the relationship between selenium and the risk of various cancers. The proposal will also dig deeper into scientific evidence of whether health claims are ‘complete, truthful and not misleading’. The proposal will enforce companies to enable the public to comprehend the information provided and to understand the relative significance of such information in the context of a total daily diet. 3. Write the public comment which you would submit to this proposal. If the proposed regulation deadline has already passed, write the comment you would have submitted. Explain briefly what you wish to accomplish with your comment. (10 points) My comment is that I encourage this new scientific study to be done so that the public is not misled on whether or not Selenium (trace mineral that is essential to good health but required only in small amounts) is beneficial to the body or not. There have been several claims that conclude that the mineral reduces the risk of certain cancers, but the FDA has ruled that these claims are very limited and......

Words: 645 - Pages: 3

Premium Essay

Fda Should Regulate Herbs

...Herbal Supplements The FDA should regulate herbal supplements as it ensures safety for the consumer. If taken properly, herbal supplements have great benefits. The problem is that there simply is not enough regulation of the herbal supplements. Many herbal supplements can be dangerous if taken incorrectly. What’s worse, people simply do not have enough information about the benefits and risks of herbal supplements. A great example of the lack of regulation is overuse of Ephedra. A while back, people started taking mass amounts of Ephedra in order to lose weight. It ended in a great amount of deaths, causing the FDA to take measures against makers of medicines containing Ephedra. Because it was considered an herbal supplement, it did not have the same scrutiny as synthetic drugs. Herbal supplements can be just as powerful as synthetic drugs, so the same vigilance in regulation should apply. Also, harmful ingredients sometimes end up in herbal supplements, which present an entirely new risk. If herbal supplements were more closely monitored, there would be a better chance of preventing this from happening. Because of the lack of regulation, consumers do not have any assurance that what they are buying is safe. Consumers need that assurance, especially when it comes to health products. There also is not very much awareness about herbal supplements. People do not realize how powerful some herbal supplements are. Many people hold the mistaken belief that herbal supplements...

Words: 996 - Pages: 4