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 labeling or news releases of any eventual contraindications. Should there be systematic or serious adverse effects, FDA may withdraw the product from the market. FDA has tended to expand and increase its regulations and requirements. An example was a typical drug, which underwent 30 clinical trials of 1,500 patients. In 1990s, it had to undergo 60 additioal clinical trials of almost 5,000 patients (FDA). Allergan's marketing strategy is moving from the 50-above age bracket of women to the 35-45 age to prevent the effects of aging. Recession has not stopped people, especially women, from spending for their looks. Allergan's shares rose 23% in the last 12 months as compared to Johnson & Johnson's fall by 4%. Thomson Reuters analysts foresee Allergan's per-share earning to increase by 14% in 2010 and 2011 (Benesh).
High Public Acceptance
A single-center, randomized, double-blind and placebo-controlled trial was recently conducted on 34 OAB male and female patients at the Guy's Hospital in London, UK from May 2004 to February 2006 (Sahai et al., 2009 p 1509). The objective was to determine if botox treatment affects the quality of life of patients with the condition, refractory to anti-cholinergics. They received 200 units of botox and their quality of life was assessed through the King's Health Questionnaire at 4 and 12 weeks after botox injection. Results showed that the majority of patients experienced improved quality of life. Their symptoms also improved in the overall at 4 weeks. It concluded that botox A bladder injections at 200 units seem to improve the quality of life and OAB symptoms of the respondents for at least 24 weeks (Sahai et al. pp 1510-15).
A MEDLINE and EMBASE evaluation of 18 clinical studies on treatment with botox intradetrusor injections on adults with neurogenic detrusor over activity or OAB and urinary continence of OAB symptoms found that it was effective (Karsenty et al., 2007). In most of the cases, 300 units of botox were injected in the bladder under cystoscopic guidance and anaesthesia. Improvement was recorded in 40-80% of the patients who became completely dry, urodynamic pressure reduced and quality of life improved. The review concluded that botox injections provide significant improvement on patients with these disorders resistant to anti-muscarinics. Botox is also quite tolerated. However, it still needs better designed controlled trials and answers to questions on optimal dose, longest duration of efficacy, timing and indications of repeat injections and patients who will best benefit from it (Karsenty et al.).
A five-minute telephone survey of 72 botox patients revealed that 67% of them were satisfied with it and considered continuing with the treatment (Hori et al., 2009). The survey was intended to evaluate their perspective on BTX -- A as a long-term treatment for their neurogenic detrusor over-activity, secondary to spinal cord injury condition. Only 7 or 15%, still undergoing botox treatment, would consider alternative permanent surgical options in the succeeding 5 years. Those considering botox on a permanent basis were younger. New recruitment rate was high at a 14.4 mean and annual withdrawal rate was low at 4.8. Because of the high satisfaction and demand rate, there is need to optimize the current delivery of intradetrusor botox injections for NDO patients (Hori et al.).
Market research reports that there are 19 companies, which are the key players in the Botox market worldwide (Global Industry Analysts, 2009). These companies include
Allergan, Inc. USA; Ipsen Group France; Lanzhou Institute of Biological Products China; Metabiologics, Inc.USA; Merz Pharmaceuticals GmbH Germany; Mentor Corporation USA, Medy-Tox Incorporated South Korea, Medicis Pharmaceutical Corporation USA, and Solstice Neurosciences, Inc. USA (Global Industry Analysts).
Observers say that U.S. FDA approval of Botox is likely and coming (Benesh, 2010). This will be the first major medical application for Allergan and boost its fortune. The benefits of Botox are temporary and its increasing stream of patients will continue keep coming back. That insures Allergan's prosperous stand. Most of these patients are women who want their wrinkles and crow's feet erased. They are sure clients every three months. And its cost is not open to insurer pressure because insurance companies do not cover it. Allergan made $1.3 billion in sales from Botox in 2009, 30% of its total revenue for the year. With its forthcoming use for migraine headaches, Allergan could make an additional $1 billion a year from it.Its CEO, David Pyott, said Botox holds 79% of the global aesthetic market and still growing at 13% every year. Its long-term development program includes a next-generation range of products for treating pain. The firm's diversification...
Botox is used to reduce glabellar lines and facial wrinkles (Global Industry Analysts, 2009). Its therapeutic applications now cover movement disorders or pain, cervical dystonia, hemifacial spasm, blepharospasm, strabismus, chronic pain, migraine, hyperhidrosis, bladder dysfunction and spasticity (Global Industry Analysts). Its applications have expanded since its approval from the FDA in 1989 for ocular dystonas (Herkovits, 2004). Dr. Alan B. Scott received permission from FDA to try botox's effect on strabismus in 1978. When it worked, Allergan acquired the rights to market the drug, initially as Oculinum. Allergan conducted additional trials for benign essential blepharospasm and cervical dystonia. Dr. Allen M. Putternam, who attended the first FDA trials, watched the application of early studies on eye muscle hyperactivity and blepharospasm. He and other researchers did not have the faintest guess about the vast potential of the drug. In 1992, Dr. Alastair Carruthers and his wife Jean first suggested the use of botox for cosmetic purposes. Since then, more and more individuals from varied disciplines outside ophthalmology discovered the capability of botox to inactivate line-producing muscles (Herkovits).
Political and Institutional Influences
Most health plans today are financers of care rather than organizers of care (Havinghurst, 2000). Few actually manage care to insure quality or that their subcontractors actually do. Managed care today is operated by subcontracting and capitation techniques to make sure health plans costs are lower. This is done by exercising purchasing power over providers and moving most of the financial risk to them. Health plans choose subcontractors on the basis of low cost. They need not have experience in treating patients and compensated in ways that may lead to neglect or under-treatment. Yet they make the decisions on clinical matters or through their physicians. Corporate power is thus exercised to reduce costs and increase profit with the necessary and significant legal responsibility over patient care (Havinghurst).
An approach to remedy this problem is the creation within the Institute of Medicine of a permanent, staffed Forum on Legal Issues in Health Care (Havinghurst, 2000). It will focus on health care and defocus on health law. Its main concern will be the law affecting the financing, delivery and quality of persona health service. A private, nonprofit entity with a broad perspective should perform this synthesizing and coordinating function. It will have a wider perspective than Congress and state legislatures, which are also influenced by lobbyists. Its goal will be to adopt a genuine "systems" approach in investigating legal rules in the health sector and guide the courts and legislatures in their performance concerning healthcare. It will be an assembly of experts, a fact-finder, distiller of knowledge and "a vital source of insights and principles" for legislators, judges and officials, advocates and academics in shaping law for the healthcare industry in times to come (Havinghurst).
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.
Ellsworth P. And Kirshenbaum E. (2010). Update on the pharmacologic management of overactive bladder: the present and the future. 30 (1) Urologic Nursing; Society of Urologic Nurses and Associates
FDA (2002). The drug development and…
Allergan's marketing strategy is moving from the 50-above age bracket of women to the 35-45 age to prevent the effects of aging. Recession has not stopped people, especially women, from spending for their looks. Allergan's shares rose 23% in the last 12 months as compared to Johnson & Johnson's fall by 4%. Thomson Reuters analysts foresee Allergan's per-share earning to increase by 14% in 2010 and 2011 (Benesh).
FDA: Center for Drug Evaluation and Research (CDER) 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
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
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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
This situation illustrates the difficulties in navigating an uncertain regulatory environment. 3. It is reasonable that the WHO 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