A Regulatory: The Food and Drug Administration

The core of the Food and Drug Administration is to uphold consumer protection, of public health. The first law created by King John of England, in 1202 called the Assize of Bread, prohibited adulteration of bread with ingredients from ground peas, and beans (FDA Basics, 2010). Federal control allowed inspecting drug supply of imported medications in 1848 (FDA Basics, 2010). Since the evolution of the administration, science continues to improve the health of the consumer. The FDA keeps abreast of developments, by regulation products. The regulations have to keep up with social, cultural, and economical change for the developments related to food and drugs. 
History and Health Care Influence 
The origins of the FDA begin with Lewis Caleb Beck in the mid-1800s performing a chemical analysis of agricultural products prior to the Department of Agriculture inception (FDA Basics, 2010). The title of the department changed in 1930 to the Food and Drug Administration. 
The Food and Drug Administration responsibility is, “protect human, and veterinary drugs, biological products, and medical devices, nations food supply, cosmetics, and products that emit radiation” (FDA Basics, 2010). The FDA evaluates innovations of medicines and foods for effectiveness, safety, and. The FDA provides the consumer, science-based information they need to use medicines and foods to improve their health (FDA Basics, 2010). 
Source and Scope of Authority 
In 1906, congressional legislation implemented the Pure Food and Drug’s Act (FDA Basics, 2010). This act currently incorporated in to the Food Drug and Cosmetic Act prohibiting interstate commerce of adulterated and misbranded food and drugs. 
The Food Drug and Cosmetic Act (FD&CA) is a federally enacted law on which the department operates. The FDA follows the Administrative Procedure Act to issue regulations. The Act gives the FDA rulemaking functions. FDA regulations are not part of the FD&CA. The FDA follows Good Guidance Practice Regulations that describes the stance of the regulatory issue (FDA Basics, 2010). 
Structure and Responsibilities 
The Center for Toxicological Research Organization supports the product centers by providing scientific technology, training, and technical expertise. 
Office of Regulatory Affairs Organization provides leadership and direction of product centers, research center, and office of Regulatory Affairs. 
The Center for Biologics Evaluation and Research Organizations regulates products for vaccines, blood, and gene therapy. This center monitors allergenic, tissue, and tissue products like bone, skin, and sperm. The department also works with transplantation of non-human cells, and tissues organs into humans. 
Center for Devices and Radiological Health Organization regulates medical devices from thermometers to dialysis machines. This center approves devices such as implants, and prosthetics. Monitoring includes radiation safety. 
Center for Drug Evaluation and Research Organization regulates over-the-counter and prescription medications. This department is responsible for items like toothpaste, and sunscreen. The products have pharmaceutical properties. 
The FDA approval process has specific steps for medication. The process begins with laboratory and animal testing. Next, testing on human subjects for safety and effectiveness evaluation. Following this, the manufacturer submits a New Drug Application. A biologic requires a Biologic License Application. The application includes, the test results, manufacturing information to ensure proper manufacturing, and the proposed label. If after review shows the benefits outweigh the risk, and manufacturing a quality product the medication meets the approval guidelines. The department is responsible for counteracting bio-terrorism, drug preparedness’, and natural disaster response. 
Center for Food Safety and Applied Nutrition Organization regulates most foods and additives, excluding meat, infant formulas, dietary supplements, and cosmetics. The FDA inspects food facilities along with the state agencies. This department regulates cosmetics to ensure safe and proper labeling. FDA approves cosmetic dyes. In 1994, The Dietary Supplement Health and Education Act amended the (FD&CA) to regulate the safety and labeling of dietary supplements (FDA Basics, 2010). The definition of a dietary supplement is a product taken by mouth intended to add dietary ingredients. 
Center for Tobacco Products Organization regulates tobacco cigarettes, rolling, and smokeless tobacco. This center is responsible for Regulatory issues and policy issues with the Family Smoking Prevention and Tobacco Control Act of 2009 (FDA Basics, 2010). 
Center for Veterinary Medicine regulates feed, drugs, and devices for animals. The FDA monitors the manufacturing and distribution of food additives and drugs given to animals. This includes meat used for human consumption. 
Example 
The Center for Drug Evaluation and Research Organization, wrote to General Mills, the manufacturer of Cheerios warning the manufacture that Cheerios statement regarding the cereal helps lower cholesterol. The FDA told General Mills to remove the statement, “diets rich in whole grain foods can reduce the risk of heart disease” (FDA calls cheerios and “unapproved drug,” 2009). The FDA warned the statements were violations of the FD&CA. The FDA informed General Mills that Cheerios is an unapproved drug that must go through the drug approval process (FDA calls cheerios and “unapproved drug”, 2009). 
Conclusion 
The Unites States Food and Drug Administration a department of the United States Department of Health & Human Services protects and promotes health by regulating more than just food, drugs, and cosmetics. The FDA works in more than an advisory capacity. The FDA works in conjunction with international programs to promote the safety and welfare of the consumer. The FDA conducts criminal investigations and institute sanctions. The department ensures emergency preparedness, and response to bio-terrorism. 


References 
FDA Basics (2010) Retrieved on February 12, 2010 from The Food and Drug Administration http://www.fda.gov/AboutFDA/Basics/default.htm 

FDA calls cheerios and “unapproved drug” (2009) Retrieved on February 12, 2010 from USA Today Magazine (138): p14-15. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=f5h&AN=43741553&site=ehost-live 

Wyeth v. Levine

Wyeth v. Levine
Pre-emption is a judicial principle of supremacy of Federal legislation over state regulations on the same subject created by Congressional legislation. State law cannot create laws on the same subject that is already occupied in federal law. Pre-emption occurs when Congress passes a law. If the regulation does not define pre-emption, state and federal courts may examine pre-emption. Wyeth argued pre-emption when Diana Levine successfully sued the health care center in Vermont. The Vermont jury ordered Wyeth to change the labeling to prohibit improper administration of Phenergan.
Case
The Supreme Court case number 06-1249, Review Vermont Supreme Court case, regarding a lack of labeling instructions for administering Phenergan resulting in the amputation of a musicians arm. The injury the Vermont jury found correlated with Wyeth’s inadequate procedures for administration. The trial court denied overturning the appeal on Wyeth’s position,
“… Pre-empted by federal law because Phenergan labeling had been approved by the federal Food and Drug Administration (FDA). The FDA deemed the Phenergan label, sufficient. The Vermont Supreme Court affirmed” (Rein, 2008).
Phenergan
Phenergan combats nausea. The route of administration injection is intramuscularly or intravenously through an IV-push into the vein. The IV-drip method introduces medication into a saline liter bag and infuses slowly. An IV-push injection resulted in the injury.
Injury
April 7th 2000, Levine saw the doctor for a migraine headache. She received Demerol, and Phenergan then sent home. She returned when the initial medication was ineffective. Levine received a second dose of the same medications. Perivascular Extravasation occurred because of the medication entering an artery directly or through the surrounding tissue coming into contact with the artery. This resulted in the limb becoming gangrene, and subsequently necessitating amputation of her right hand and forearm.
The Arguments
Wyeth labeling acknowledges gangrene following intra-arterial injection. The manufacturer identifies amputation as a result. The argument presented the failure of instructions including methods of administration regarding IV-drip, rather than intravenous injection. Intravenous administration held a higher risk than the IV-push method.
Levine argued a conflict between Wyeth and the FDA regarding ‘failure to warn’ action. Levine argued the lack of contraindication of the IV- push method, and not administer intravenously.
Wyeth argued state-law duty contraindicates the IV-push method. In response to the Supreme Court, the Vermont Supreme Court responded stating the jury position. The position of the jury was that Wyeths had insufficient labeling, without mandating changes to the label.
The Supreme Court stated, “We therefore need not decide whether a statue rule proscribing intravenous administration would be pre-empted” (Wyeth v. Levine, 2009).
Food and Drug Administration
Upon review of correspondence between the FDA and Wyeth requested strengthen the warning regarding intra-injection method and evidence of objection to strengthen language. The court also reviewed FDA failure to responds to the change to the label upon request. The court cited lack of evidence that the FDA objected to strengthening the language. The warning, “when administering any irritant drug intravenously it is usually preferable to inject it through the tubing of an intravenous infusion set that is know to be functioning satisfactorily” (Wyeth v. Levine).
In 1987, The Food and Drug Administration requested Wyeth to change the labeling to include the risk of arterial exposure. Wyeth submitted the application without receiving a response from the Food and Drug Administration. The FDA in 1996 requested labeling information in use excluding response to the 1987 request. The FDA advised Wyeth to retain the instructions, regarding the arterial injection. The changes to labeling did not relate to the injection. The application sent from Wyeth to the FDA received approval for the (1981) application in 1998. The instruction from the FDA regarding the label must be match the application.
Legislation
In 1962, Congress switched the burden of proof responsibility to the pharmaceutical manufacturers, from the FDA. Congress in 1906 implemented the Federal Food and Drugs Act. The act pertaining to the case prohibits misbranding drugs. In 1930, Congress passed the Federal Food, Drug, and Cosmetic Act. The Food and Drug Administration requires pre-approval of all medications, submitting applications with reports of studies and drafts of labels for review. Distribution does not begin until the application approval. Congress preserved state law by a stating the law would invalidate, with direct evidence to the contrary.
The Supreme Court Ruling
The Supreme Court concluded that Wyeth failed to follow state and federal regulations. Levine’s case common-law claim lacks pre-emption to the Federal Food, Drug, and Cosmetic Act.
Conclusion
After the injury in 2007, Congress amended the Federal Food, Drug, and Cosmetic Act for the first time. This amendment gave statutory authority to require need for safety labeled until approval. Congress though did not enact pre-approval changes for FDA in the Senate bill. The Senate adopted the rule to clarify the manufacturer’s responsibility to update labels. Wyeth stated that if they had changed the label Wyeth would be in violation of the Act for misbranding drugs.



References
Rein, Brent (2008) On writ of certiorari to the vermont supreme court brief for petitioner. Retrieved on February 7, 2010 from Pharmalot.com at http://www.pharmalot.com/wp-content/uploads/2008/05/wyeth-levine-brief.pdf
Wyeth v. Levine (March 2009). Supreme court of the united states, case number 06-1249 certiorari. Retrieved on February 2, 2010 from Supreme Court of the United States, 2008 term opinions of the court http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf