PHARMACY LAW History Overview: 1906-Present Federal Regulation of Medications: Development, Production, and Marketing The Federal Food, Drug and Cosmetic Act (FDCA) provides for the comprehensive regulation of all drugs introduced into intestate commerce. The intent of the law is to protect consumers from adulterated or misbranded foods, drugs, cosmetics, or devices. Historical Overview of the FDCA Pure Food and Drug Act of 1906 The law prohibited the adulteration and misbranding of foods and drugs in interstate commerce. This law fell short of providing the protection the Congress intended. Examples of this can be United States Vs Johnson, 221 U.S. 488, when the U.S. Supreme Court decision held that the misbranding provision
CASE STUDY QUESTIONS 1. The case study references on statute. Identify it and explain what it prohibits. Texas Penal Code section 42.09(a)(3), prohibits the desecration of a venerable or inanimate object. 2.
Policy-Making in the Federal System Rona Harris POL 201 Instructor: Roger Pao June 3, 2013 Policy-Making in the Federal System The expression federalism itself exemplifies the concept of collective although separate powers. In a federal system national and local governments obtain power from the citizens (Levin-Waldman, 2012, p. 66). The guidelines affirm actions federal and local state governments must consider to impose legislation upon its citizens. The Affordable Health Care for America Act (Obama-care) passed and signed into law in 2010. However, considered by its opponents as unconstitutional, the Supreme Court intervened and in a five to four decision upheld the health care law as constitutional in 2012.
However, the state statute is contrary to the federal law. The state law is * Valid. * Invalid as preempted by the Necessary and Proper Clause. * Invalid as violating the dormant Commerce Clause. * Invalid as preempted by the federal law under the Supremacy Clause.
The Court, in this case, ruled that the prohibition of distribution of contraceptives to persons under the age of 16 did not serve any compelling state interest and, therefore, ruled that the statute was unconstitutional. Questions 1. 2. 3. 4.
The Supreme Court stated that the statue did not meet the states goal of preventing breaches of peace because there was already a Texas statute which prohibited all breaches of the peace. The Supreme Court ruled that the Texas statute was inconsistent with the first amendment and they got rid of the statute. 7.) Difference between case law and statutory law? Focus on how case law and statutory laws are created, the
The plain meaning of this language might indicate a limited power to regulate commercial trade between persons in one state and persons outside of that state.“ (Thomas, 2014). The main reason for developing the effects on interstate commerce test was to conclude if it violates the dormant Commerce Clause: “(…) The United States Supreme Court has developed a series of test to determine whether a state regulation that affects interstate commerce violates the dormant Commerce Clause.” (Giachino, 2001). 3. Is most commerce considered “interstate commerce”? Why or why not?
Antitrust Law and the Ethical Ramifications of Generic versus Brand Name Drugs Antitrust laws are on the books in the U.S. to prevent companies from cornering the market on a specific product, ensuring fair competition and lower prices for consumers. Antitrust law dates back to 1890 when the Sherman Act was introduced to ensure healthy market competition by limiting the ability of a company to monopolize the market on a product in order to purposely limit trade (Cyprus, 2011). Other laws have been enacted specifically in the pharmaceutical market to ensure fair trade, while still allowing for companies to recoup the R and D expenses of manufacturing a new drug. In 1984, the Hatch-Waxman Act was put into law to promote generic drugs, but also leave a window of exclusivity to the original company who manufactured the drug to recoup its R and D costs (CPTech, n.d.). Many pharmaceutical companies have been involved in litigation regarding their alleged attempts to monopolize their drugs.
Attorney’s General from varies states including South Carolina, Washington, Michigan, Texas, Colorado, Alabama and North Dakota – have come together in determining whether or not the Healthcare Bill in the U.S. Senate violates the 10th Amendment of the U.S. Constitution. The 10th Amendment stipulates that powers not granted to the national government nor prohibited to the states by the constitution of the United States , are reserved to the states or the people. As such, the 10th Amendment may pose constitutional challenges to the bill itself. Does the constitution grant to the federal government the “power” to provide healthcare? More curiously, does the constitution grant to the federal government the “power” to mandate that people buy anything - including health insurance.
Our nation was made for the federal government and state governments to have their own separate laws, and that whatever federal law there is in place, states can’t make laws that affect the federal ones. In response to this, I feel that the federal government should let the state governments have medical marijuana laws, but work together to make the state laws legal on the stance that it doesn’t affect the federal laws that are already in place. Speaking on behalf of the federal government thinking that with state medical marijuana laws in place, will make the controlled substance act ineffective, my argument, which is also the state governments argument, would be that the state laws won’t make the act ineffective because the marijuana isn’t being sold from state to state. In addition, if it does end up effecting interstate commerce then the federal government can then prosecute those people not following the Act. All in all, if the medical marijuana is regulated properly then the federal government won’t lose oversight of illegal drugs.