The “math wars”

Aside from the requisites of do doses manufacturing, a dose companionship moldiness as headspring consecrate the hunchledge on the legal flavour of the pharmaceutical business. A company must be able to have it off what agencies of the government he has to seek advice from before it undergoes the manufacturing transition in assign to withstand a good start.Relative to this, the company needs to whap which regulates the rubber eraser and efficacy of the drugs to be manufactured and which agency protects the pay offs of the producer and the consumers against illicit drugs.This opus will discuss the flockonical responsibilities of the Food and dose Administration and the medicine Enforcement Agency including the laudation plow of manufacturing a generic wine drug replica. nutrition AND DRUG ADMINISTRATION AND ITS RESPONSIBILITIES The Food and dose Administration (FDA) is generally amenable for ensuring the skillfulty and efficacy of all drugs for human and veterinary wasting disease.FDAs 1mission argument peculiar(prenominal)ally states that the administration is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical exam devices, our acress food supply, cosmetics, and products that emit radiation. This will then give us the brain why FDA need to regulate drugs, and that is to ensure that they atomic issuing 18 safe and impressive. The administration is a equal held responsible for ensuring that the drugs have information that is honest and hi-fi for the general public to use.The Drug Enforcement Agency (DEA) (Drug Enforcement Administration for the United States) is in the first place responsible for the enforcement of the Controlled Substances Laws and Regulations. In the United States, DEA is under the wing of the Department of Justice, where it serves as an arm of the secureice against the 2those organizations and princip al members of organizations, involved in the growing, manufacture, or dissemination of tick offled substances appearing in or destined for illicit traffic in the United States. The DEAs drugs of concern include Cocaine, marijuana, heroin, inhalants, LSD, Ecstasy, Steroids, Oxycontin and Methamphetamine.The following list of specific responsibilities is adopted by this writer from the DEAs official website Investigation and provision for the pursuance of major violators of controlled substance laws operating at interstate and international levels. Investigation and preparation for prosecution of criminals and drug gangs who perpetrate violence in our communities and terrorize citizens with with(predicate) fear and intimidation. Management of a national drug intelligence program in cooperation with federal, state, local, and foreign officials to collect, analyze, and disseminate strategic and operational drug intelligence information.Seizure and forfeit of assets derived from, traceable to, or intended to be used for illicit drug trafficking. Enforcement of the provisions of the Controlled Substances Act as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances. Coordination and cooperation with federal, state and local law enforcement officials on mutual drug enforcement efforts and enhancement of such(prenominal)(prenominal) efforts through exploitation of potential interstate and international investigations beyond local or limited federal jurisdictions and resources.Coordination and cooperation with federal, state, and local agencies, and with foreign governments, in programs designed to press the availability of illicit abuse-type drugs on the United States market through nonenforcement systems such as crop eradication, crop substitution, and training of foreign officials. Responsibility, under the policy guidance of the Secretary of State and U. S. Ambassadors, for all programs associated with dru g law enforcement counterparts in foreign countries.Liaison with the United Nations, Interpol, and other organizations on matters relating to international drug control programs. DEAS PROGRAMS AND OPERATIONS Drug Enforcement Agency also updates its programs and operations concord to the demand of technology and the development of young methods of illicit drug operations. upstart report published in the KT4 Online alerted the public on the emergence of culpable websites that be bringing prescription drugs out into the market (KT4 Online, August 24, 2007).The DEA describe that such websites are able to market their products development just source cards as payment modes. The agency now referred the so-called page pharmacies to the congress for the legislation of a much formidable law for such illegal and dangerous activities, which are adjust because such companies do non meet the standards set by the United States. Even medicinal or herbal gives that are non yet studied or regulated under the law is also under the responsibility of the DEA to study and make research relative to its danger in the human health.In Utah, a inhering plant called salvia divinorium, has been put into attention by the Hill gloriole Force Base which tally to initial findings bed cause hallucinations. In the report published in the Salt Lake Tribune, magic mint as its street relieve oneself, is ingested or inhaled ordinaryly by the members of the military and the people inner the base (Salt Lake Tribune, August 20, 2007). The herbal plant is still legal as it is still under research by the DEA. Experts also say that the plant that grows in the wilds of Utah can cause lung irritation when its dried leaves are inhaled.LAWS AND POLICIES GOVERNING GENERIC DRUGS The regulations pertaining to generics drugs are under the responsibility of the Food and Drug Administration. Under the law, pharmaceutical companies or drug shapers have all the right to apply for a generic as sume of their brand drugs. It can also be that a manufacturer seeks for a license from the brand name company to make a generic copy of the branded product. A generic copy of the drug is called authorized generics because the branded product manufacturer had given the authority to the manufacturer of the generic drug copy.However, these generic copied have to undergo the legal work out that is regulated by the FDA. It is the Drug price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Waxman-Hatch Act, which is macrocosm used as a legal basis for FDA for regulate generic drug copies. Since the law was enacted over 23 years ago, the number of generic manufacturers and number of generic drug products on the market have expanded exponentially (Coster, John M. 2007). The law allows a generic drug that is a generic copy of the pioneer drug to be clear by FDA to be marketed by the same company.This is even without the submission of the usual New Drug Ap plication (NDA) that is submitted in full when a branded product is world applied for marketing. The NDA is usually a time-consuming and expensive clinical trials required to be done by the drug manufacturer in order to comply with the safety and efficacy standards required of them. With the Waxman-Hatch Act, NDA is being replaced with the submission of Abbreviated New Drug Application (ANDA) provided that the generic copy has demonstrated the fact that it is bioequivalent to the pioneer drug (J.Coster, The Pharmacist, Vol. 32, No. 6, 2007). This process allows the generic copy to be approved for marketing the easier and faster appearance because it does not to prove its safety and effectiveness through trials since the pioneer drug had already proven such. For the ANDA of the generic drug to be approved, its pioneer drug must have the four required certifications (1) that no patent is listed for the pioneer drug (2) that the patent has authorized (3) the date on which the patent will expire or (4) that the patent is invalid or not infringed.Such information is listed in the FDAs Orange Book, a reference for the pharmacists in de termining the interchangeableness of the drugs. Just recently, the Waxman-Hatch Act has been replaced with 3McCain-Schumer Act, after its authors Senators John McCain and Charles E. Schumer. The main feature of the stark naked act is the changing of the 180-day exclusivity term of the first generic drug copy to only the 30-day term. Exclusivity, in the old law is granted for the manufacturer of the generic drug to market the product exclusively within 180 long time that is for the manufacturer who first secured the FDAs approval of the generic copy.With the brisk law, exclusivity term is shortened for the purpose of further price decrement of the generic drugs as competition is encouraged after the 30-day term. It is estimated, according to Schumers study that the new law will enable consumers to save 60% of their usual put d own when buying branded drugs and that will give consumers a total of $71 billion savings in 10 years (Bash, Dana, CNN Online, May 01, 2001). Schumer cited Claritin, a prescription allergy drug as example which prices an fair of $63. 65 while its generic equivalent will only cost $25. 46.Generally, the new law is of great help for the Americans in terms of their medical expenditures. CONCLUSION By looking into the basic responsibilities and functions of the FDA and DEA, we were able to have an idea of the basic legal aspect of drug manufacturing and marketing. Also by having an overview of the laws organization generic copy manufacturing, we were able to have the basic familiarity of how the approval process rolls. In general we can conclude that the legal process of drug manufacturing and marketing is really a long and expensive process for the companies specially for the branded or patented drugs.However with the Schumer-McCain Act, the process is shortened and had benefited especially the consumers for enabling the cheaper version of their branded medicine to be marketed. REFERENCES 1FDAs Mission Statement. Retrieved on August 26, 2007 from http//www. fda. gov/opacom/morechoices/mission. hypertext markup language 2DEA Mission Statement. Retrieved on August 26, 2007 from http//www. usdoj. gov/dea/agency/mission. htm 3Senate Passes Ground-Breaking Schumer-McCain generic wine Drug Bill (Press Release). July 31, 2002. Retrieved on August 26, 2007 from http//schumer. senate. gov/SchumerWebsite/pressroom/press_releases/PR01124.html Bash, Dana. McCain, Schumer introduce generic drug bill. CNN Online. May 01, 2001. Retrieved on August 26, 2007 from http//archives. cnn. com/2001/ALLPOLITICS/05/01/senate. genericdrugs/index. html Coster, John M. The Waxman-Hatch Generic Drug Law 23 Years Later. The Pharmacist. June 19, 2007. Vol. 32 No. 6 Griffith, Christopher, et. al. (2002). realize from Washington Senate approves changes in generic-drug approval. Leydig, Vo it Mayer, Ltd. Report. October 2002. Volume 3 Issue 4 Colonel bans use of magic mint herb. Salt Lake Tribune. August 20, 2007. Retrieved on August 26, 2007 from http//www.sltrib. com/News/ci_6668009 national Authorities Warn Against Online Rogue Pharmacies. KT4 Online. Retrieved on August 26, 2007 from http//www. ktiv. com/News/index. php? ID=16295 What FDA Regulates. Retrieved on August 26, 2007 from http//www. fda. gov/comments/regs. html There has evermore been a debate on whether the maths be taught should be the old basics or the standards amend mathematics. Basic mathematics primarily comprises arithmetic and enumeration. This is just simple mathematics which involves solving simple equation and memorizing formulas.Basic mathematic also comprises the following list t o f items. There is the accurate counting to 100 or more, mastery of basic facts for all four operations, pencil and paper computation skills with hole numbers, decimals and fractions and solving percent pro blems. Other aspect includes the knowing and using formulas for area and perimeter of basic shapes. Though the above list is a bit simplified its basic position is that kids only get to know or so basic stuff. Basic mathematics can also be referred to as trivial pursuit mathematics meaning that children are to know the content not the practicability (John, 1999).On the other travel by shed light on mathematics has higher level of difficulty and has set five goals. These are that learners should comfort mathematics, be confident in the ability to do mathematics and beget mathematics problem solvers. They should as well be able to channelize well mathematically and learn to reason mathematically. It involves the four basic process standards which are problem solving, communication, reasoning, and connections. It entails gearing the children to develop the ability to think than just memorizing the mathematics concepts.Those who believe in the reform mathematics talk intimately mathematical power, the ability to reason and solve unique problems (John, 1999). It is important to observe that even if the two go upes appear to differ there are some things they share in. Benefits and demerits of basics Basic mathematics requires instructor center appeal which involves teaching the mathematics through drill and practice. However in this way the children can end up not being intrinsically motivated. This prevents them from knowledge mathematics facts and how to connect to the real world.Furthermore the approach is essentially instructor directed, and coordinate only for basic skills instructions. This approach comes with advantages and single outs as far as basic mathematics teaching is concerned. One of the advantages is that, it is clear that for learning to be effective there must be a knowledge source and this is what the teacher act as. The teachers have attained their unifications and expertise from colleges and universities to become experts in t heir fields. In this reasoning its convenient to involve to someone who is already an expertise in the field to impart that knowledge in the scholarly persons.For example according to Kelly, if the savants have a top dog on atopic raised by the textual matter book, the teacher is present ton as the expert to answer the question (Kelly, 2004). Other benefits include good planning and execution of knowledge casual process and good discipline. The disadvantage of this style is that no one can predict which parts of the information the student has learned will in the end become obsolete or incorrect, what the student will forget, or what new information he will need to know in the emerging (Howard, 1980).Furthermore according to Howard in some cases the students can obtain a ridiculous security if they believe that, once information ins dispensed and a cognitive framework provide the student will incorporate the information, recognize where and when it could and should be applie d when time comes. One great disadvantages of this method is that a heavy investment in the style can lead to rigid, standardized, and less(prenominal) pliable ways of managing students and their concerns (Howard, 1908). This acts as huge impediment to development and self uncovering within the student.This huge impediment has been seen as the greatest drawback for this style of administering knowledge. The benefits and demerits of reform mathematics style According the student center online answers, the best approach of teaching mathematics should stress active, student centered learning in real life context (student center). This may help in qualification the concepts more understandable and interesting. This therefore calls for the student knowing the crafts before they can apply them and that is where the basic mathematics comes handy. The reform mathematics takes the student centered approach of learning.This involves instructions where by the students actively create knowl edge for themselves. It consists of chemical group learning, inquiry, and humanistic learning activities (student center). This method has additional advantages both to the student and the teacher some which are enlisted below. To begin with the student would develop learning and knowledge that will help them throughout their life. In this method students always fancy that learning is fun and interesting. Furthermore, through this method teachers always have less traditional work. This is more prominent in the upper class levels where the students are mature enough.The student gets to be more attentive and willing to accede in the class activities. In this way there is a reduction in the number of complaints about fairness and unequal treatment. When student assoil out research and group works they generate a striation of information that the teacher may add to his collection of information. However this method also comes with some disadvantages. It poses a problem when it come s to evaluation in that this has to be individualized. Providing one test for the whole class has to be abandoned. Every student has to be evaluated based on his or her goals.One other big disadvantage of this method is that there some student who do not connect well with it in spite the teachers best efforts. Such scenario is always more prevalent in the lower classes levels even though it can also be found in the upper classes. The other demerit is that the students always have to work in groups. There occur complaints about being put in teams. However the complaints get to seize as the student get to understand that it is what the real world is like. Under some pot student may find it hard to work in teams since well-nigh of them have never had the experience of team work. ConclusionIt is important to note for the reform mathematics, the fact that it takes the student centered learning method gives it an upper hand as method of teaching mathematics. In fact students do consid er the real world experience eve when they do not like them that much (daymalyn, 2009). This is therefore more appropriate and practical than the basics math which would d lead to rigidity and less development of the kids as well as new advancement in the mathematics fields. References Howard S & Robyn M. (1980), occupation Based Learning An Approach to Medical Education, Springer Publishing Company, ISBN 0826128416, 9780826128416.Daymalyn (2009), Disadvantages and disadvantages of student center learning, Accessed on August 7, 2010, from http//wwwemmalynombayan-daymalyn. blogspot. com/2009/09/advantages-and- disadvantages-of-student. html John A. (1999), Reform mathematics Vs. The Basics Understanding the Conflict and Dealing with It Accessed on August 7, 2010 from http//mathematicallysane. com/depth psychology/reformvsbasics. asp Kelly K. (2004), the Math Wars, a Short Analysis, Accessed on August 7, 2010 from http//www. newfoundations. com/ConAnalysis/KellyMathWars. html Student center, Accessed on August 7, 2010 from http//www. abacon. com/woolfolk7/faq. html