Wait a second!
More handpicked essays just for you.
More handpicked essays just for you.
Common medical terminology
Common medical terminology
Common medical terminology
Don’t take our word for it - see why 10 million students trust us with their essay needs.
The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:
Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA's jurisdiction!)
The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would "depress the market for out-of-state drugs that are approved by FDA."
The implication of
As we noted then, the FDA holds that an "interstate commerce" test must be applied to all steps in a product's manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.
This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government's failure to cite any judicial precedent for their argument.
The implication of the FDA's interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company
Holdings Although, many states had abolished the “impact rule,” Florida still follows to the rule. However, the court concluded that there was an impact and that the impact rule does not preclude the claim. Moreover, the court rephrased the certified question to whether the impact rule bars the claim for damages for emotional distress caused by the consumption of a foreign substance in a beverage product where the plaintiff suffers no accompanying physical injuries.
Are stem cells ethical to use in medical research? The most basic cells in the human body are stem cells. Because doctors use stem cells for medical treatment of chronic ailments, stem cells play an important role in human medical research. However, despite the benefits of stem cells in medical treatment, controversy surrounds the methods employed to obtain them. Should researchers continue to use stem cells?
Economic responsibility requires a company to remain profitable in order to appease stakeholders and risk management and sound business practices play a large role in acceptable economic responsibility. Johnson and Johnson may have tried too hard to increase its profits, which resulted in mediocre production rather than timely inspection to ensure the products are safe for distribution. A halt in production may decrease profits temporarily, but in the long run, products distributed will be safer and revenue would resume to a normal amount. Instead, trying to be profitable and avoid loss in the short run made Johnson and Johnson less profitable in the long run. Failure in legal responsibility may have caused Johnson and Johnson to fail. The Food and Drug Administration (FDA) regulates drug distribution and has several criteria to pass in order to allow Johnson and Johnson to administer its premier medicines such as Tylenol. Not adhering to those laws allowed the distribution of unsafe medicines, subsequently leading to recalls and damaging the company financially. Johnson and Johnson tried covering up prior recalls of Motrin by hiring contractors to buy every packet (Kimes). Ethical responsibility requires companies do not perform questionable practices such as that described. The secret recall bought attention to Johnson and Johnson that it makes shoddy products out of the public’s view, which is wrong on many ethical bases. In the recent occurrence with Tylenol, Johnson and Johnson slacked on its labeling and tarnished the company’s
and yet simple of the act, which severely impacts pharmacy and is forbidden by the PDMA, is the act of knowingly trading, purchasing, or knowingly selling a prescription drug sample. This offense is punishable for a fine of up to two hundred and fifty- thousand dollars, and up to ten years of imprisonment. Many pharmacists do not realize is that there is a fee of up to one hundred and twenty five thousand dollars for the individuals who provide information leading to the conviction of a violator of the PDMA. Another important portion of this vast law is that it prohibits pharmacists to resale of any prescription drug that was previously purchased by hospitals or any other health care facility. The provision was intended to eliminate a major source of drugs in the diversion market such as; drugs that were originally purchased by hospitals or health care facilities at substantially discounted prices, as allowed by the Nonprofit Institutions Act of 1938, and then resold to the retail class of trade. Congress believed that the resale of such drugs created an unfair for of competition. Re...
Although Pfizer was not required to warn the public and Kline, they were responsible for warning physicians. Pfizer dismissed Kline’s Complaints pursuant to Federal Rule of Civil Procedure 12(b)(6), which successfully dismissed Counts I and VII. Motion to Dismiss under Federal Rule of Civil Procedure 12(b)(6) “for failure to state a claim for which relief can be granted.” As the Plaintiff, Kline should have provided several sets of proof in order to support his claim and be granted the relief. Kline failed to provide the Fact Sheet and Authorization forms under the Joint Coordinate Plan.
The current Food and Drugs Regulations appear quite solid. Definitions are made for a variety of terms such as “daily value”, and rules are made with very specific scopes, breaking down stakeholders (consumers, producers/retailers) into groups so that there is s...
that the FDA is too regulatory and picky. However in the process of them not listening to the
There was many of opinions against, however, to call for a new law expanding the FDA's authority. This argument was changed by the thalidomide tragedy, in which thousands of babies were born with messed up heads or bodies after their mothers took thalidomide which was put on the market for treatment of nausea during pregnancies. Thalidomide had not been approved for use in the U.S. because of the concerns of an FDA reviewer, Frances Kelsey about thyroid toxicity. However, thousands of samples had been sent to American doctors during the investigation of the drug's development, which at the time was entirely unregulated by the FDA. Individual members of Congress cited the thalidomide incident in lending their support to expansion of FDA
Despite the significant portion of Americans that do not support embryonic stem cell research, it should be federally funded because of the potential health benefits, the definition of human, and the opportunity to clearly define regulations for ethical research. The wide range of prospective uses for stem cells could greatly improve the health and wellbeing of many people. In stem cell treatments, undifferentiated cells are programmed to form specific cells, which can then be transplanted to the afflicted area. Stem cells can possibly treat afflictions including “Alzheimer’s disease, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis” (“Stem Cell Basics”). Another important use is drug testing.
"About FDA." Why Are Animals Used for Testing Medical Products? N.p., n.d. Web. 10 Mar.
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
U.S. Food and Drug Administration. “CFR -- Code of Federal Regulations Title 21” (21CFR101.9). U.S. Food and Drug Administration. U.S. Department of Health & Human Services, 1 Apr. 2013. Web. 21 Mar. 2014.
The FDA most definitely has the important task to assure U.S. citizens the availability of safe food and drugs. This importance was realized by the men that worked toward moving it into legislation. The resultant agency continued to enforce its policies consistently into the modern century without a loss of momentum. However if the FDA is impaired by means of a governmental shutdown then it is of great importance to continue the consistency in food and drug standards that it holds. Standards that hold great importance today like the standards of the FDA’s initiation.
U.S.C. Title 21 - FOOD AND DRUGS. (n.d.). FDA. Retrieved July 1, 2014, from http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapVI-sec361.htm
Excerpts of Statues Relevant to the Development and Approval of Drugs, Medical Devices, & Medical Foods for Rare Diseases or Conditions.