Fda 's Position On Regulation Of Drug Promotion And Advertising

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

Despite this, the industry did not alter its ways, maintaining that its ad campaigns were "educational," and that people were able to make their own decisions about what they purchased (Payer 66). However, it is evident that the advertisements produced by the pharmaceutical industry are designed for the very purpose of making it difficult for people to make these decisions independently. This marketing produces a large number of often deceptive, misleading tactics which have a large influence on both consumers and medical practitioners. The chief beneficiaries of this marketing are not the consumers but the pharmaceutical companies themselves.

This policy paper is going to analyze and show the strategic use of public policy. The law is called the Pure Food and Drug Act of 1906, which is a law to protect consumers from purchasing adulterated or mislabeled food or drug products. This law also led to the creation of the Food and Drug Administration, is a federal agency of the United States Department of Health and Human Services. In my policy paper, I will be providing a comprehensive history of Pure Food and Drug Act of 1906 in the next section to give a general and brief description regarding to the background of this Act, and see why the law is necessary. Next, I will be trace the implementation of Pure Food and Drug Act, and its code and agency to provide an insight of how the law was passed. For decades, this law has made a huge impact on the business and society, and many progressive food, drug manufacturers, and the general public worked actively to support the law. Lastly, I will be conducting a policy analysis of this law to observe the strengths and weaknesses of this policy, and formulate some recommendations for further improvement of this act.

As one of the primary federal consumer-protection laws in existence today, The Federal Food and Drug Act of 1906 was a law that had two primary goals for food and drugs: (a) forbid harmful ingredients and additions and (b) demand labeling of ingredients to inform consumers. According to Janssen (1981), it was hoped that the enactment of this law would eliminate adulterations and poisons sometimes found in foods, sometimes in drugs and often in both. The foundation of food and drug protection came from the development of scientific methods of analysis by the Federal Bureau of Chemistry,

The first Pure Food and Drug Act was put into action by Theodore Roosevelt in 1906. The act was passed to prevent the manufacture, sale, or transportation of misbranded or harmful food, drugs, medicines, and liquors. Due to this act the Food and Drug Administration (FDA) came to be. The FDA is now responsible for the testing of all foods and drugs for human consumption and the label warnings on them as well.

During this time the first DTC print advertisement for Merck an “antipneumococcal vaccine, Pneumovax(pneumococcal vaccine polyvalent) was printed in Reader’s Digest (Ventola).” That created a chain effect and shortly later “Boots Pharmaceuticals ran the first DTC broadcast advertisement, which promoted the lower price of its prescription brand of ibuprofen (Rufen), compared with Motrin (Ventola).” Today, the US pharmaceutical industry spends $3.1 billion on advertising prescription drugs directly to consumers.

In 1906 the Food and Drug Act was officially created by the president at the time that was Theodore Roosevelt. The job of the FDA is to protect the health of the public and doing so by assuring that human and veterinary drugs are safe and secure along with biological products, medical devices , food supply in the US, cosmetics, and products that have been introduced to radiation. It’s important because they ensure the foods you are consuming can be eaten without getting you sick. They also ensure the medicine you get is not going to cause harm to you. Without the FDA the drugs we get from pharmacies and the food we get from stores would have the possibility of being very unsafe and hurtful. The FDA has created many regulations that products have to go through to be considered FDA approved. Some of those include the safety of the food we consume, products that contain tobacco, dietary supplements, medications from pharmacies, vaccines, and blood

The Food, Drug, and Cosmetic Act of 1938: Sulfonamide tested for flavor and fragrance but not safety, children died and 350 more were poisoned. This act made it so the sale of unsafe drugs could be stopped, that toxic drugs could be seized, and the burden of proof was given to the manufactures to show data of safety experiments.

Food and drug administration is a department of U.S health and human services. It’s responsibility is to test the safety and efficacy of new drugs entering the market as well as to make sure that these medicines are quickly accessible to people. The Food, Drug, and Cosmetic Act has been passed in 1938 to ensure that foods other than meat, poultry and fish are clinically hygienic and safe to eat. This act also requires that the food should be labelled according to its content. (FDA.org) Drugs and tobacco are also regulated by FDA and in 1996, FDA strictly regulated the use of tobacco products like nicotine, cigarettes and smokeless tobacco, by children and adolescents because of the increase in diseases prevalence and tobacco addiction. Annually 40000 deaths are attributable to its use and most of them are of premature. Therefore the goal of FDA is to stop the tobacco addiction by minors and prevent the deaths and diseases due to nicotine addiction. (FDA vs Brown, n.d) This essay will cover the food and drug administration’s role in under and over regulating drugs and medicines and how it effects our economy, health care system and patients health and safety.

Barkan, Ilyse D. Industry invites regulation: the passage of the Pure Food and Drug Act of 1906. American Journal of Public Health January 1985: Vol. 75, No. 1, pp.

| Created the Food and Drug Administration (FDA). It forbids the manufacture or sale of adulterated or fraudulently labeled foods and drugs.

What some viewed as “overregulation” was criticized for being “unnecessarily cautious and bureaucratic” and there was an increasingly pertinent pressure from the industry and economic conservatives to speed up the new drug review process. Some research showed that throughout this era of regulation, the typical new drug took more than 12 years from initial synthesis to FDA approval and that the FDA review process by itself took 2.6 years. However, because public interest and opinion continued to align with the idea that the FDA should aim to prevent the sale of unsafe or ineffective drugs in the U.S. in hopes to avoid Type I errors in drug approval, the agency was not immediately responsive to this pressure. This alignment, however, shifted in response to the AIDS epidemic and the activism that came with

The Pure Food and Drug Act was first implemented in 1905 by President Theodore Roosevelt but it was not officially a law until 1906 and its main purpose was to make sure all food and drug labels were labeled accurately (Hart & Ksir, 2013, p. 53). This act was created in order to fix the American food and drug industry because “At the turn of the 20th century, America’s food supply was enshrouded in unsafe and disgusting practices. Diseases were rampant as American slaughter and packing houses were not regulated nor checked for sanitation purpose” (“Pure Food and Drug Act” 2015).

In the articles “Prescription Drug Ads Should Be Better Regulated” and “Prescription Drug Advertising Empowers Patients”, the authors discuss the impact of prescription drug advertising on drug costs, consumer behaviors and consumers and Doctors’ relationship. While pharmaceutical companies support prescription drug advertising because they think that its effects are positive, Naomi Freundlich claims that prescription drug advertise should be more controlled. Because “Administration is underfunded and lacks the resources to enforce many of the regulations that are already in place” “big pharmaceutical companies must do a better job with self-regulation” (Naomi) in order to reduce the negative consequences of prescription drugs ads.

In the 1980’s, drug companies were banned from advertising prescription drugs to consumers. That same decade brought changes in these regulations allowing companies to advertise, mostly in