The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
In United States law, ripeness refers to the readiness of a case for litigation; "a claim is not ripe for adjudication if it rests upon contingent future events that may not occur as anticipated, or indeed may not occur at all." For example, if a law of ambiguous quality has been enacted but never applied, a case challenging that law lacks the ripeness necessary for a decision.
The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary.
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), is an important United States Supreme Court case in U.S. administrative law. It ruled that the Food, Drug, and Cosmetic Act did not give the Food and Drug Administration (FDA) the authority to regulate tobacco products as "drugs" or "devices." This was later superseded by the Family Smoking Prevention and Tobacco Control Act, which granted the FDA the authority to regulate such products.
Gonzales v. Oregon, 546 U.S. 243 (2006), was a landmark decision of the US Supreme Court which ruled that the United States Attorney General cannot enforce the federal Controlled Substances Act against physicians who prescribed drugs, in compliance with Oregon state law, to terminally ill patients seeking to end their lives, commonly referred to as assisted suicide. It was the first major case heard by the Roberts Court under the new Chief Justice of the United States.
Virginia State Pharmacy Board v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976), was a case in which the United States Supreme Court held that a state could not limit pharmacists’ right to provide information about prescription drug prices. This was an important case in determining the application of the First Amendment to commercial speech.
Whalen v. Roe, 429 U.S. 589 (1977), was a case brought before the Supreme Court of the United States. The case involved a New York state prescription monitoring law requiring reporting and storing of information concerning all Schedule II drug prescriptions. Physicians were required to report the name of the prescribing physician; the dispensing pharmacy; the drug and dosage; and the patient's name, address, and age. This information was then stored by the New York Department of State.
Toilet Goods Association, Inc. v. Gardner, 387 U.S. 158 (1967), was a case heard before the United States Supreme Court. It held that judicial review of a regulation's validity was inappropriate because the controversy was not ripe for adjudication. Since it was not clear whether or not an inspection would be ordered and the reasons had not been given by the Commissioner to justify his order, no primary conduct was affected and so no irremediable adverse consequences flowed from requiring a later challenge to the regulation by a manufacturer, who refused to allow inspection.
Wyeth v. Levine, 555 U.S. 555 (2009), is a United States Supreme Court case holding that Federal regulatory approval of a medication does not shield the manufacturer from liability under state law.
In Pacific Gas & Electric Co. v. State Energy Resources Conservation & Development Commission, 461 U.S. 190 (1983), the United States Supreme Court held that a state statute regulating economic aspects of nuclear generating plants was not preempted by the federal Atomic Energy Act of 1954. The case provides a framework that has guided other cases involving preemption of federal authority.
Reno v. Condon, 528 U.S. 141 (2000), was a case in which the Supreme Court of the United States upheld the Driver's Privacy Protection Act of 1994 (DPPA) against a Tenth Amendment challenge.
Ashwander v. Tennessee Valley Authority, 297 U.S. 288 (1936), was a United States Supreme Court case that provided the first elaboration of the doctrine of "Constitutional avoidance".
The National Conference of Commissioners on Uniform State Laws developed the Uniform State Narcotic Drug Act in 1934 due to the lack of restrictions in the Harrison Act of 1914. The Harrison Act was a revenue-producing act and, while it provided penalties for violations, it did not give authority to the states to exercise police power regarding either seizure of drugs used in illicit trade or punishment of those responsible.
Sorrell v. IMS Health Inc., 564 U.S. 552 (2011), is a United States Supreme Court case in which the Court held that a Vermont statute that restricted the sale, disclosure, and use of records that revealed the prescribing practices of individual doctors violated the First Amendment.
The Supremacy Clause of the Constitution of the United States establishes that the Constitution, federal laws made pursuant to it, and treaties made under its authority, constitute the "supreme Law of the Land", and thus take priority over any conflicting state laws. It provides that state courts are bound by, and state constitutions subordinate to, the supreme law. However, federal statutes and treaties must be within the parameters of the Constitution; that is, they must be pursuant to the federal government's enumerated powers, and not violate other constitutional limits on federal power, such as the Bill of Rights—of particular interest is the Tenth Amendment to the United States Constitution, which states that the federal government has only those powers that are delegated to it by the Constitution.
Ciba-Geigy Canada Ltd. v. Apotex Inc., [1992] 3 SCR 120, is a Supreme Court of Canada judgment on trademark law and more specifically the issue of passing off. Ciba-Geigy brought an action against Apotex and Novopharm, alleging that their versions of the prescription drug metoprolol were causing confusion to the public due to their similar appearance to Ciba-Geigy's version of the drug Lopresor. On appeal to the SCC, the issue was whether a plaintiff is required to establish that the public affected by the risk of confusion includes not only health care professionals but also the patients who consume the drugs in a passing off action involving prescription drugs of a similar appearance. The Supreme Court held affirmatively on this question.
POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014), was a United States Supreme Court case that held that a statutory private right of action under the Lanham Act is not precluded by regulatory provisions of the Food, Drug, and Cosmetic Act.
Lambert v. Yellowley, 272 U.S. 581 (1926), was a decision by the Supreme Court of the United States that reaffirmed the National Prohibition Act's limitation on the dispensation of alcoholic medicines. The five-to-four decision, written by Justice Louis D. Brandeis, affirmed the dismissal of a suit in which New York City physician Samuel Lambert sought to prevent Edward Yellowley, the acting federal prohibition director, from enforcing the Prohibition Act so as to preclude him from prescribing alcoholic medicines. The decision affirmed the police powers of the individual states, as well as the power of the Necessary and Proper Clause of the United States Constitution, which was cited in upholding the Prohibition Act's limitations as a necessary and proper implementation of the Eighteenth Amendment to the United States Constitution.
Akamai Technologies, Inc. v. Limelight Networks, Inc., 797 F.3d 1020, is a 2015 en banc decision of the United States Court of Appeals for the Federal Circuit, on remand from a 2014 decision of the U.S. Supreme Court reversing a previous Federal Circuit decision in the case. This is the most recent in a string of decisions in the case that concern the proper legal standard for determining patent infringement liability when multiple actors are involved in carrying out the claimed infringement of a method patent and no single accused infringer has performed all of the steps. In the 2015 remand decision, the Federal Circuit expanded the scope of vicarious liability in such cases, holding that one actor could be held liable for the acts of another actor "when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance." In addition, the court held that where multiple "actors form a joint enterprise, all can be charged with the acts of the other[s], rendering each liable for the steps performed by the other[s] as if each is a single actor."
Chy Lung v. Freeman, 92 U.S. 275 (1876), was a US Supreme Court case that ruled that the powers to set rules surrounding immigration and to manage foreign relations rest with the US federal government, rather than that of the states. The case has been cited in other Supreme Court cases related to government authority on matters relating to immigration policy and immigration enforcement, most recently in Arizona v. United States (2012).
