FDA: Center for Drug Evaluation and esearch (CDE)
And Over-the-counter Weight Loss Medications

Obesity is one of the most serious epidemics facing the American public. "Over two-thirds of adults in the United States are overweight or obese, and over one-third are obese" (Overweight and obesity statistics, 2012, WIN). To address concerns about obesity, many adults turn to over-the-counter medications like dietary supplements that promise the user easy weight loss. The medications usually claim to increase metabolism and suppress appetite, while some also claim to inhibit the absorption of carbohydrates and calories. According to a recent study: "an estimated 15.2% of adults (women 20.6%, men 9.7%) had ever used a weight-loss supplement and 8.7% had past year use (women 11.3%, men 6.0%); highest use was among women aged 18 to 34 years (16.7%)" (Blanck et al. 2007). The FDA has tried to prevent the use of weight loss supplements with tainted ingredients and…...

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References

Blanck (et al. 2007). Use of nonprescription dietary supplements for weight loss is common among Americans. Journal of the American Dietetic Organization. 107(3):441-7.

Dietary supplements. (2012). FDA. Retrieved:

 http://www.fda.gov/Food/DietarySupplements/default.htm 

FDA regulation of nutritional supplements. (2012). FDA. Retrieved:

Given that there is no expectation of substantial equivalence, the following process will need to be undertaken.
The 510(K) that needs to be submitted is the Traditional. A Special is for modifications to products that already have 510(k) approval, so that does not apply in this case. An Abbreviated 510(K) applies when a product is approved for this process by the FDA. There is little explanation on the FDA website of what that means, or what the definitions of the terms it uses are. But with a device that does not have equivalence, there is little likelihood that with new technology this product would be eligible for the abbreviated FDA process.

The different types of documentation that need to be submitted along with the Traditional 510(K) can be found here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm

The decision letter is the final stage of the process, wherein the FDA informs the company of its decision about the…...

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Works Cited:

FDA.gov. (2009). 510(K) Substantial Equivalence decision making process. FDA.gov. Retrieved April 16, 2012 from  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134783.htm?utm_source=fdaSearch&utm_medium=website&utm_term=substantial%20equivalence&utm_content=10 

FDA.gov. (2009) How to prepare a traditional 510(K). FDA.gov. Retrieved April 16, 2012 from  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134572.htm 

FDA.gov. (2010). Medical devices. FDA.gov. Retrieved April 16, 2012 fromhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

Phase II consists of efficacy trials of the drug, which are tested on volunteers of the target population. When everything goes right, the drug manufacturer discusses the development process, continued human testing, other concerns and protocols for phase III with the FDA. Phase III is the more extensive. It is at this time that the manufacture can work for the accelerated development and review of the drug. Treatment IND and parallel tracking also occur at this stage or phase. Upon completion of phase III, the manufacturer files a New Drug Application or NDA, which is reviewed for 1-2 years. At this stage, the FDA consults advisory committees of experts for advice on safety, effectiveness and labeling. If and when approved, marketing may be done with FDA-regulated labeling. FDA also collects safety information on the drug's use and adverse effects, if any. There will be occasional requests for changes in…...

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BIBLIOGRAPHY

AAD (2005). Botulinum toxin. American Academy of Dermatology. Retrieved on July

25, 2010 from  http://www.aad.org/public/publications/pamphlets/cosmetic_botulinum.html 

Benesh, P. (2010). Allergan's botox nears U.S. approval to treat migraine. Investors Business Daily: Investors Business Daily, Inc. Retrieved on July 25, 2010 from http://www.investors.com/NewsAndAnalysis/Article/541624/201007261859/Allergan-Botox-Nears-U.S.-Approval-To-Treat-Migraine.aspx

Duthie J. et al. (2008). Botulinium toxin injection for adults with overactive bladder syndrome. Issue 3, The Cochrane Collaboration: Wiley Publishers.

Gene Therapy
FDA

Ethics can be considered to come from personal values. From both a medical and a business perspective, ethics are the reasons that some news stories should be followed from beginning to end and all in between. "On Sunday morning, 23 February 1997, the world awoke to a technological advance that shook the foundations of biology and philosophy. On that day, we were introduced to Dolly, a 6-month-old lamb that had been cloned directly from a single cell taken from the breast tissue of an adult donor." (Brannigan 10) This report is not about cloning per se, but it is about the underlying industry for gene therapy and the Food and Drug Administration regulations as they pertain. The secondary goal is to point out who controls the legal aspects of a new drug application process. Like cloning, gene therapy is in some circles a great medical and scientific breakthrough while…...

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References

Brannigan, Michael C. Ethical Issues in Human Cloning: Cross-Disciplinary Perspectives. New York, NY: Seven Bridges Press, LLC, 2000.

Food and Drug Administration. "Cellular & Gene Therapy Products." Retrieved on December 7, 2009, from FDA at:  http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/default.htm 

Murphy, Dano B.. "Guidance for Industry: Guidance for Human Somatic Cell, Therapy and Gene Therapy." U.S. Department of Health and Human Services, Food and Drug, Center for Biologics Evaluation and Research Administration. March 1998.

Divisions of the FDA
The FDA is in charge of the regulation of pharmaceutical drugs and medical devices, as part of its mandate to safeguard the U.S. health care system. One unit for this is the Center for Devices and adiological Health (CDH), which approves medical devices. The unit that approves drugs is the Center for Drug Evaluation and esearch (CDE). There is also the Center for Biologics Evaluation and esearch (CBE), which is responsible for the evaluation of biological products used in health care.

Each of these organizations will have a number of different products that are going through the different stages of approval. The agencies do not comment on drugs that are currently going through the approvals process, as that would be unfair to the drugs, the companies that make them, and their shareholders. The new drug approval process, however, does not end when the initial drug is approved. The…...

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References

FDA (2015). Homeopathic product regulation: Evaluating FDA's regulatory framework after a quarter-century. Food and Drug Administration. Retrieved March 31, 2015 from  http://www.fda.gov/Drugs/NewsEvents/ucm430539.htm 

NIH. (2013). Homeopathy: An introduction. National Institutes of Health. Retrieved March 31, 2015 from  https://nccih.nih.gov/health/homeopathy

Administrative Law
REGULATING STEM CELL THERAPY

Administrative Agency: Food and Drug Administration

Article 1 Section 1 of the federal Constitution creates administrative agencies, which are law-making entities but with limited powers (USLegal, 2014). The rules and regulations created by an administrative agency are lawfully enforceable. It assists in the faster management of cases and is, therefore, a big help to U.S. courts. The administrative process is also a valuable resource for other important case. Members of an administrative agency are necessarily experts in their field (USLegal)..

One such agency is the Food and Drug Administration or FDA, which is under the U.S. Department of Health and Human Services or HHS (USgov, 2014). It is charged with the mandate to protect the health of the public by insuring the safety, efficacy and security of human veterinary drugs, biological products, medical devices, food supply for the country, cosmetics and radiation production. It likewise disseminates accurate and…...

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BIBLIOGRAPHY

AABB (2014). How are stem cells regulated? American Association of Blood Banks.

Retrieved on May 16, 2014 from http://www.aabb.org/resource/bct/therapy/facts/Pages/regulated.aspx

Cell Therapy Cluster (2014). U.S. federal appeals court decision. Retrieved on May 16,

2014 from  http://www.celltherapycluster.eu/en/news/99-us-federal-appeals-court-decision-propagated-stem-cells-are-a-drug.html

This situation illustrates the difficulties in navigating an uncertain regulatory environment.
3. It is reasonable that the HO guidelines are used as the framework for U.S. policy. The U.S. system, however, is unique in certain ways. You alluded to the need to encourage innovation. The balance between innovation and cost control is different in the U.S. than in Europe, so I think that is why U.S. policy will look slightly different than European policy. It will be interesting to see how that plays out. In Europe, there has obviously not been much innovation in this field in the past few years, if new product introductions are any indicator. If the U.S. system can stimulate more innovation, that can actually be used to demonstrate the power of the American model and perhaps drive changes in Europe, rather than the other way around.

orks Cited:

Riley, K. (2009). FDA approves first drug for treatment…...

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Works Cited:

Riley, K. (2009). FDA approves first drug for treatment of peripheral T-cell lymphoma. FDA. Retrieved November 19, 2009 from  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183799.htm

The philosophy behind clinical trials goes back nearly fifty years, to the Kefauver-Harris Drug Amendments. The objective of a trial is twofold -- to understand the benefits and risks of a drug. The FDA has an obligation to the public that is just as great if not greater than their obligation to the industry. They are willing to support the industry through the most important approvals processes when necessary, such as with AZT. From the researcher's point-of-view, the requirements for additional data may be a pain, but they are also a pain for the FDA as well because of the additional resources they must dedicate to analyzing that data. There are a lot of sides to this debate. From the point-of-view of the researcher or the drug company, additional trial requirements and demand for larger data sets may be onerous, but it is worth considering the issue in the…...

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Works Cited:

Farley, D. (no date). Benefit vs. risk: How FDA approves new drugs. MDAdvice. Retrieved November 16, 2009 from http://www.mdadvice.com/resources/clinical_trials/fda.htm

Pharmaceutical Law
Perhaps one of the greatest ethical challenges of pharmaceutical marketing will be a result of overreach of the Justice Department with respect to its interpretation of the First Amendment. Indeed, in his dissenting opinion in Sorrell v. IMS Health, Inc., Justice Breyer argued, "If the Court means to create constitutional barriers to regulatory rules that might affect the content of a commercial message, it has embarked upon an unprecedented task -- a task that threatens significant judicial interference with widely accepted regulatory activity" (Berman, 2011, p. 36). A pharmaceutical manager would do well to observe how contemporary views about free speech and the robust influence of money -- whether legitimate or corrupt -- have on the pharmaceutical industry. The influence of the digital age on commerce and communication cannot be overstated. The strength of this influence is particularly evident in the article on off-label promotion (Berman, 2012) and the…...

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References

Berman, J.R. (2012, March-April). First Amendment off-label promotion cases work their way through the courts. Journal of Health Care Compliance, 14(2), 33-39.

Ofek, El & Laufer, R. (2008). Eli Lilly: Developing Cymbalta. [Case Study 9-507-044]. Boston, MA: Harvard Business School Publishing.

Quelch, J.A. (2013, November 7). GlaxoSmithKline in China (A). [Case Study 9-514-049]. Boston, MA: Harvard Business School Publishing.

Quelch, J.A. (2014, April 29). 23 andMe: Genetic testing for consumers (A). [Case Study 9-514-086]. Boston, MA: Harvard Business School Publishing.

Medical devices: FDA should take steps to ensure that high -Risk device types are approved through the most stringent premarket review process.
Medical Device Reporting (MDR)

Medical Device Reporting (MDR) is the name of the Act that allocates control to the Food and Drug Administration to monitor results of medical devices in order to make sure that no adverse effects results to society. The FDA receives information on this account from all manufacturers, users, and importers of medical devices who, if they experience a problem, are obligated to report this problem to the FDA so that these problems can be treated directly. User Facilities (e.g., hospitals, nursing homes), moreover, are required to report these problems to both the FDA and the manufacturer. Even if the user facility only suspects a serious result to have occurred because of the device but is not certain, nonetheless, the suspicions should still be reported to both…...

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Source

Medical Device Reporting - General Information www.rcb.ca.gov/forms_pubs/attach6.pdf

FDA - Medical Device Reporting (MDR)  http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

Responsibility and Awareness of Regulatory Status The responsibility or lack thereof concerning the Food and Drug Administration (FDA) to the public is cause for concern and is of personal interest. Regulations and deregulations are important as a father, husband, and member of the community for personal views that I hold. First, a loved one has a red meat allergy that has been disregarded by pharmaceutical companies and the FDA. Secondly, she is employed by the local hospital and observes a concerning number of individuals with like immunocompromising deficiencies. If the FDA standardizes and regulates suppliers instead of third-party inspection agencies, millions of others like her may conclude viable alternatives in the United States and abroad. The FDA’s inability to regulate effectively can transform personal relationships adversely.
A review of academic literature consists of detailed analysis and observations concerning regulatory schemes. In 1938 the Federal Food, Drug, and Cosmetic Act was introduced with…...

ICH Guidelines and FDA egulations
One of the biggest challenges with drug regulations is the different standards which are utilized by numerous countries around the globe. This is problematic, as these disparities make it hard for manufacturers to follow certain protocol when researching, testing and introducing new drugs to the marketplace. As a result, ICH and FDA regulations are becoming streamlined to offer greater amounts of transparency. To fully understand the way that this is occurring requires examining ethical and regulatory requirements which must be accounted for in the design of a clinical research study. This will be accomplished by conducting a literature review of various sources. Together, these elements will illustrate how the two standards are becoming integrated to achieve these larger objectives. (Carson, 2007)

Carson, P. (2007). Good Clinical, Laboratory and Manufacturing Process. Cambridge: Cambridge University Press.

In 1996, the FDA and ICH guidelines were integrated together. The result is that…...

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References

Carson, P. (2007). Good Clinical, Laboratory and Manufacturing Process. Cambridge: Cambridge University Press.

Schnoll, L. (2008). The Regulatory Compliance Act. Chico, CA: Patton Professional.

Narcotics Lollipop a. Should the FDA ban the narcotics lollipop? Go through the steps of the linear model to decide how this issue could be resolved.
Define Problem

The problem to be addressed is whether or not the narcotic lollipop should be barred. Answering this question requires consideration of various factors. Questions raised include:

Is the narcotic fentanyl too dangerous for children?

Is the narcotic fentanyl more dangerous than the tranquilizers used?

Is the lollipop as a means of distributing the drug also a problem?

Do doctors make up their own unregulated sedatives to calm children before surgery?

Is the lollipop preferable if the alternative is the unregulated sedatives doctors use?

Is there a problem with controlling the dosage of the drug?

Gather Evidence

Fentanyl is a drug used to treat chronic pain, pain associated with operative procedures and used to enhance general anaesthetics. It is commonly used as a preoperative medication to sedate patients prior to surgery, including being…...

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References

Kain, Z.N. Perioperative Psychological Issues in Children. American Society of Anesthesiologists, 2000. Retrieved October 4, 2002. URL:  http://www.asahq.org/NEWSLETTERS/2000/08_00/perioperative0800.html 

Lacy, C., Armstrong, L.L., Ingrim, N., & Lance, L.L. Drug Information Handbook. Hudson OH: American Pharmaceutical Association, 1997.

Thalidomide
Although the United States succeeded in averting the same thalidomide tragedy that occurred in Europe by refusing to approve the drug, some observers counter that the action introduced unnecessary delays in the approval of many useful drugs. Given that thalidomide is now accepted as an effective treatment for leprosy, this paper provides an evaluation concerning whether Dr. Frances Kelsey was correct in stopping the development of thalidomide in the United States in 1960, followed by a summary of the research and important findings in the conclusion.

In 1961, two doctors working independently in Australia and Germany determined that thalidomide, a sedative and n anti-nausea drug that was being prescribed for pregnant women, was responsible for a wave of birth defects (Carpenter, 2010). Based on their analysis of the available data concerning thalidomide, the two physicians, Drs. McBridge and Lenz, determined that thalidomide caused birth defects when taken during the first…...

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References

Annas, G., & Elias, S. (1999, January). Thalidomide and the Titanic: Reconstructing the technology tragedies of the twentieth century. American Journal of Public Health, 89(1),

98-101.

Brown, V.J. (2009, February). New insights into thalidomide. Environmental Health

Perspectives, 117(2), 61.

Limiting DTC drug ads
The moratorium on direct-to-consumer (DTC) prescription drug ads protected patients because it enabled health care practitioners and other professionals to make educated, informed decisions about potentially harmful substances rather than the consumer relying on materials designed exclusively at sales, promotion, and marketing.

DTC drug ads should be again limited by the FDA because the advertisements are potentially misleading, causing consumers to request drugs that they have seen on television or in print ads. These ads can offer what are essentially "miracle" cures, while downplaying potential harmful side effects or by failing to mention other alternatives. "Most direct-to-consumer advertising does not warn patients of drug-drug interactions," ("Direct to Consumer Advertising"). Moreover, many patients might stop taking the medication they are currently on because they see an ad for something else.

The FDA should be dedicated to promoting public health and safety. If prescription drug advertisements interfere at all with this…...

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Works Cited

Collins, Susan, et. al. "Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations." United States General Accounting Office. Oct 2002. .

'Direct to Consumer Advertising for Prescription Drugs." American College of Physicians. 9 Oct 1998. .

'Prescription Drugs and Mass Media Advertising." National Institute for Health Care Management Research and Educational Foundation. Nov. 2001. .

Title: The Opioid Epidemic: A Multifaceted Crisis with Profound Social, Economic, and Public Health Implications

Introduction:
The opioid epidemic has become a significant public health crisis in the United States, causing widespread devastation and claiming countless lives. This essay aims to explore the multifaceted nature of the opioid epidemic, delving into its social, economic, and public health implications. By analyzing the causes, consequences, and strategies for addressing this crisis, we can gain a deeper understanding of its impact on individuals, communities, and the nation as a whole.

1. Historical and Cultural Context:
The opioid epidemic has deep-rooted historical and cultural origins. Understanding the evolution....

1. The Role of Technology in Transforming Health Care Delivery

Discuss the latest technological advancements in health care, such as telemedicine, AI-powered diagnostics, and wearable health trackers.
Explore how technology can improve access to care, reduce costs, and personalize treatments.
Analyze the ethical implications of using technology in health care and the potential for data privacy and algorithmic bias.

2. Addressing Health Disparities through Policy Interventions

Identify the root causes of health disparities based on race, ethnicity, socioeconomic status, and geographic location.
Evaluate the effectiveness of existing policy interventions aimed at reducing disparities, such as Medicaid expansion and community health centers.
....

Ethical Considerations in the Use of Ritalin: Essay Topics

1. The Balancing Act of Medication and Stigmatization

Explore the ethical dilemma of prescribing Ritalin to children with ADHD, weighing the potential benefits of symptom management against the social stigma associated with mental health medications.
Discuss the importance of informed consent and parental involvement in decision-making, ensuring that parents are fully aware of the potential risks and benefits before starting treatment.

2. Equitable Access and Economic Disparities

Examine ethical concerns surrounding the disproportionate use of Ritalin among children from lower socioeconomic backgrounds.
Investigate the role of systemic factors, such as lack of access....