President Franklin D. Roosevelt signed the Federal Food, Drug, & Cosmetic Act into law in 1938. This is one of the laws you will need to be familiar with as you study to become a pharmacy technician. Learn more at http://rxtechstudy.blogspot.com/ --Music - "Constancy Part II" by Kevin MacLeod @ Incomepetech (royalty free) --Photos - United States Government & Public Domain
A 2009 court case further defining the court's interpretation of section 331 of the FDCA act and cases of negligence per se
valentine day video redone : 2012 GlaxoSmithKline $3 billion ($1B criminal, $2B civil) Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program Avandia, Wellbutrin, Paxil, Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex; False Claims Act/FDCA 2009 Pfizer $2.3 billion Off-label promotion/kickbacks Bextra/Geodon/ Zyvox/Lyrica False Claims Act/FDCA 2013 Johnson & Johnson $2.2 billion Off-label promotion/kickbacks Risperdal/Invega/ Nesiritide False Claims Act/FDCA 2012 Abbott Laboratories $1.5 billion Off-label promotion Depakote False Claims Act/FDCA 2009 Eli Lilly $1.4 billion Off-label promotion Zyprexa False Claims Act/FDCA 2001 TAP Pharmaceutical Products $875 million Medicare fraud/kickbacks Lupron False Claims Act/ Prescription Drug Marketing Act 2012 Amgen $762 million Off-label promotion/kickbacks Aranesp False Claims Act/FDCA 2010 GlaxoSmithKline $750 million Poor manufacturing practices Kytril/Bactroban/ Paxil CR/Avandamet False Claims Act/FDCA 2005 Serono $704 million Off-label promotion/ kickbacks/monopoly practices Serostim False Claims Act 2008 Merck $650 million Medicare fraud/kickbacks Zocor/Vioxx/Pepsid False Claims Act/ Medicaid Rebate Statute 2007 Purdue Pharma $601 million Off-label promotion Oxycontin False Claims Act 2010 Allergan $600 million Off-label promotion Botox False Claims Act/FDCA 2010 AstraZeneca $520 million Off-label promotion/kickbacks Seroquel False Claims Act 2007 Bristol-Myers Squibb $515 million Off-label promotion/ kickbacks/Medicare fraud Abilify/Serzone False Claims Act/FDCA 2002 Schering-Plough $500 million Poor manufacturing practices Claritin FDA Current Good Manufacturing Practices 2006 Schering-Plough $435 million Off-label promotion/ kickbacks/Medicare fraud Temodar/ Intron A/K-Dur/ Claritin RediTabs False Claims Act/FDCA 2004 Pfizer $430 million Off-label promotion Neurontin False Claims Act/FDCA 2008 Cephalon $425 million Off-label promotion Actiq/Gabitril/Provigil False Claims Act/FDCA 2010 Novartis $423 million Off-label promotion/kickbacks Trileptal False Claims Act/FDCA 2003 AstraZeneca $355 million Medicare fraud Zoladex Prescription Drug Marketing Act 2004 Schering-Plough $345 million Medicare fraud/kickbacks Claritin False Claims Act/ Anti-Kickback Statute
Facts: Pom Wonderful, LLC (Pom Wonderful), a California-based beverage company, sold various types of juice, including a pomegranate blueberry juice blend. In 2007, Coca-Cola Company (Coca-Cola) announced its own version of a pomegranate blueberry juice. In 2008, Pom Wonderful sued Coca-Cola in federal district court and argued that Coca-Cola misled consumers into believing that Coca-Cola's product contained pomegranate and blueberry juices when it actually contained 99% apple and grape juices and only 0.5% pomegranate and blueberry juice. Specifically, Pom Wonderful claimed that Coca-Cola violated provisions of the Lanham Act, a federal law prohibiting false advertising, as well as California's false advertising and unfair competition laws. The lawsuit challenged the name, labeling, marketing, and advertising of Coca-Cola's product. The district court held that Pom Wonderful's claims regarding the name and label of the juice were barred by a separate law, the Food, Drug and Cosmetics Act (FDCA). The FDCA allows the Food and Drug Administration (FDA) to regulate the labels on, among other items, juices. Because the FDA has exclusive authority to file claims for violations of the FDCA, the court feared that a decision under the Lanham Act would undercut the FDA's authority to regulate juice labels. After both parties gathered evidence, the court granted summary judgment in favor of Coca-Cola on the name and label issues. Although the court gave Pom Wonderful the opportunity to proceed to trial on the remaining issues, Pom Wonderful conceded that it could not win without the name and label issues. Pom Wonderful appealed. The U.S. Court of Appeals for the Ninth Circuit affirmed the lower court's decision to bar Pom Wonderful's claim with respect to the name and labeling of Coca-Cola's juice. It vacated the lower court's ruling in favor of Coca-Cola, instead allowing Pom Wonderful's case to proceed on the remaining claims. Question: Did the U.S. Court of Appeals err when it held that FDA regulations barred Pom Wonderful's claim for false advertising under the Lanham Act? Conclusion: Yes. Justice Anthony M. Kennedy delivered the opinion for the 8-0 majority. The Court held that, while it is the duty of the courts to harmonize statutes, the best way to do that in this case does not entail barring POM Wonderful's Lanham Act claims. Neither the Lanham Act nor the FDCA explicitly forbids or limits Lanham Act claims on labels that the FDCA regulates. The Court held that, because the Lanham Act and the FDCA have coexisted since the passage of the Lanham Act in 1946 without Congress addressing the issue, Congress has evidently not seen a problem with their potential interferences. Therefore, holding that the FDCA precludes the operation of the Lanham Act would represent a disregard for the legislative intent of having the two statutes complement one another. Justice Stephen G. Breyer did not take part in the discussion or decision of this case. For more information about this case see: https://www.oyez.org/cases/2013/12-761 Section 1: 00:00:05 Section 2: 00:18:19 Section 3: 00:28:33 Section 4: 00:54:11 PuppyJusticeAutomated videos are created by a program written by Adam Schwalm. This program is available on github here: https://github.com/ALSchwalm/PuppyJusticeAutomated The audio and transcript used in this video is provided by the Chicago-Kent College of Law under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License. See this link for details: https://creativecommons.org/licenses/by-nc/4.0/
A podcast done for Medical Packaging 452 with Dr. Laura Bix. Recorded on the campus of Michigan State University on December 8, 2009.
Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act abbreviated as FFDCA, FDCA, or FD&C, is a set of laws passed by Congress in 1938 giving authority to the US Food and Drug Administration FDA to oversee the safety of food, drugs, and cosmetics A principal author of this law was Royal S Copeland, a three-term US Senator from New York2 In 1968, the Electronic Product Radiation Control provisions were added to the FD&C Also in that year the FDA formed the Drug Efficacy Study Implementation DESI to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs3 The act has been amended many times, most recently to add requirements about bioterrorism preparations The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form4see elixir sulfanilamide disaster It replaced the earlier Pure Food and Drug Act of 1906 Contents 1 Contents 2 Food coloring 21 Certifia Federal Food, Drug, and Cosmetic Act Click for more; https://www.turkaramamotoru.com/en/federal-food-drug-and-cosmetic-act-37758.html There are excerpts from wikipedia on this article and video
Fireside chat by Paul Links, Brian Harris, and James D
Comments on Hans rosling and Sheryl Wedunn's TED talks