Consumer interest attorney James Turner and neuroscientist, Dr. John Olney, filed an objection to the FDA’s approval. In addition to their objection, Dr. Adrian Gross, an FDA toxicologist, was questioning methods used by Searle for anther of their products, Flagyl. A taskforce which included Dr. Gross, investigated studies on several of Searle’s products, including aspartame. Based on the findings of the first taskforce, the FDA set up another taskforce to review three studies on aspartame which Searle had submitted.
FDA can issue warnings to companies that violate rules and regulations such as cGMPs. Gulf Pharmaceutical Industries (2/23/12) and Laboratories Jaloma S.A. de C.V. (3/9/12) are two companies that received warning letters in 2012 from the FDA’s Office of manufacturing and Product Quality.12 Gulf Pharmaceutical Industries was cited for adulterated products due to cGMP violations that require manufactures to take specific steps to prevent contaminantion. The warning letter stated the specific CFR code violated, a request for corrective actions and supporting documentation, and a specific deadline to respond to the letter. In addition, the FDA warned the company that their products will be not be accepted into the United States until there is proof of cGMP compliance and corrective actions are implemented. Laboratories Jaloma S.A. de C.V. had a similar warning letter for noncompliance to standards and cGMPs.
Question 2 1 out of 1 points Correct The Food and Drug Administration (FDA) is investigating reports that Caplets Pharmaceutical Corporation is putting potentially harmful additives in Doze, a new pain-relief medication. The FDA's demands for particular documents from Caplets Answer Selected Answer: d. must be general so as to force an uncooperative party's compliance. Correct Answer: d. must be general so as to force an uncooperative party's compliance. Question 3 1 out of 1 points Correct Before adopting new regulations to govern Internet-based phone services, the Federal Communications Commission may not Answer Selected Answer: d. ignore the Administrative Procedure Act to streamline proceedings. Correct Answer: d. ignore the Administrative Procedure Act to streamline proceedings.
Aspartame Myrex Martinez University of Phoenix Instructor: Julia L.G. Kressig, J.D. November 1, 2009 Aspartame is an artificial sweetener and used as a food additive. Investigations of G.D. Searle’s research practices had the Food and Drug Administration held on the approval of Aspartame. Aspartame is trademarked by NutraSweet, Equal and Splenda, etc.
Describe briefly our society's underlying motivations for the establishment of governmentalregulation and the control of drugs and drug use, differentiating between regulating drug use andtaking a laissez-faire approach. 2a. Some of the underlying motivations for establishing government regulations were that the toxicity of drugs became a concern. The sellers of certain drugs were considered to be endangering the health of the public. There were no regulations that were in place that made the sellers tell how much and what particular ingredients were in the drugs that were being sold.
Discuss the following a. Qui tam is known as whistleblower suits. In qui tam action a relator with personal knowledge of a fraud brings the suit against a defendant of behalf of the government. The knowledge with which the relator brings a qui tam action must be public knowledge but information that would not otherwise be available without the qui tam suit. b. HIPAA Privacy rule is the Health Insurance Portability and Accountability Act of 1996. HIPAA was enacted to improve the Medicare and Medicaid programs and the efficiency and effectiveness of the healthcare system by encouraging the development of a health information system through the establishment of standards and requirements for the electronics transmission of certain health information.
Constitutional Law Essay #1 Date September 23, 2012 How should the court decide PAM’s claim? Pam is challenging the Drug Act of being unconstitutional. First, State X is embarking on creating their own drug access program. State X needs to be aware of the federal constitutional limitations, the impact of the Medicaid program, and how the federal and state discount programs affect patient access to pharmaceutical care. The US Constitution imposes 2 principles of constraints on state pharmacy drug programs.
Role and Functions of Law Paper Jelizia M. Rivera LAW/421 November 18, 2012 David Feldheim Role and Functions of Law Paper This paper will discuss the case of Cipollone V. Liggett Group, Inc. I will also discuss the functions and roles of law in business and society. I will explain how the functions and roles of law that plays a part in my past or present job(s). Cipollone V. Liggett Group, Inc. Cipollone brought suit against Liggett for violation of several New Jersey consumer protection statutes alleging that Liggett (and other cigarette manufacturers) were liable for his mother’s death because they engaged in a course of conduct including false advertising, fraudulently misrepresenting the hazards of smoking,
Infants of nursing mothers taking Codeine may have an increased risk of Morphine overdose if the mother is ultra-rapid metabolizer of Codeine. (FDA, 2007) One important caution about Codeine is that it has been proven to have a habit-formatting effect. Therefore, any large volume and continues use of this drug is not recommended and should only be used by a person who prescribed for (AHFS, 2011). Globally, the United Nation’s Single Convention on Narcotic Drug categorizes Codeine as Schedule II and IV drug, which put Codeine under a relatively strict monitoring (INCB, 2012). In the United State, Codeine is regulated by the Controlled Substance Act.
For instance, it only makes sense that welfare recipients should have to take a drug test in order to qualify for benefits. People say that this is unfair by singling out the poor people, or that it invades their privacy. This simply isn’t true. Some companies have people submit to a drug test even before they go through the interview process when applying for a job. This is because the companies have realized the benefits that can come from a drug-free workplace.