Communications Methods

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

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.

Communication has been permanently changed by social media. A wide conceptual definition of social media, as cited in Ressler & Glazer (2010), is “The online and mobile accessible services that enable individuals to connect, collaborate, and share with others in real time.” Social media has an obvious influence on informal communication style and represents both possibility and liability for healthcare institutions. As cited in Bernhardt, Alber, & Gold (2014), “Social media provide healthcare professionals with tools to share information, to debate health care policy and practice issues, to promote health behaviors, to engage with the public, and to educate and interact with patients, caregivers, students, and colleagues.” It also presents challenges, including risks to information accuracy, organizational reputation, and individual privacy. Social media can be a very helpful in communicating among nurses and other healthcare providers while creating professional connections, and sharing experiences, but guidelines for appropriate use by healthcare providers are essential. Whether or not certain healthcare organization decides to use social media as a communications tool - social media policy still need to be implemented. Policies help establish an organization 's rules and expectations around social media.

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

Approaching the task of having to communicate with your customers to affectively resolve their problem can be a difficult task, therefore using various negotiation techniques in the process will be very important. Before anyone would contact a customer regarding their problem, you would always need to know what has to be achieved in the long run of the discussion, as you will effectively be working towards what’s best for their service whilst it being beneficial towards both customer and the organisation. Sometimes customers may need something improved on their service which is out of the ordinary, therefore it is my task to comprise and introduce other products or services that we have available to offer in order for their satisfaction and a positive customer experience. Listening carefully is one of the most crucial aspects of negotiation, as you must be able to offer new products and services whilst communicating with customers, which can be proven to be quite the task itself, therefore you would always have to be alert and listen very carefully to their needs in order to offer them the correct product or service for their need.

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses

As the communication coordinator for this national drug manufacturer, we will need to address the issue at hand and figure out the best way to handle the negative publicity one of our medications has caused. Unfortunately, the local news is already making things more difficult for us by alleging that a well-known public figure is among those suffering adverse effects from this medication. We will need to decide how to properly address the public that will ensure no loss in business or investors. In this meeting, we will need to determine the best communication tactic to get this situation under control.

How we communicate effects everything we do. Whether talking to patients and family members, speaking in a team meeting, or talking with our children’s teacher at a conference, communication is how we learn information, teach information and express our concerns. With this paper I will discuss; the definitions of healthcare communication, the relevancy of effective personal healthcare communication with other healthcare professionals, clients, and patients, the relevancy of effective professional healthcare

“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products,

Since the FDA has a lot of responsibility in our society with it regulating our food and drug safety it is best to come to understand it better.

Consumers will be more likely to initiate a conversation with their physician after seeing an advertisement on television, or in a magazine. In a paper titled An Insider 's Perspective: Defense of the Pharmaceutical Industry 's Marketing Practices, author Kanika Johar (2013) writes, "In my experience, the goal of DTCA is to increase market share for the new drug by bringing awareness to a particular disease that the drug treats" (p.10). The first part of that sentence is remarkably candid. As an industry insider, Johar admits that increasing market share is the goal of DTCA. While proponents cite education and awareness as reasons to continue DTCA, research consistently shows that consumers are not educated in any meaningful way about drugs and their side effects in a 2 minute commercial or a tiny 4 point font, need a degree in biotechnology to understand, print advertisement (Frosch et al, 2010; Arnold & Oakley, 2013).

A majority of patients feel that DTCA gives them enough information to decide whether to discuss a drug with their doctor (the 2002 FDA survey reported 86 percent).Foley and Gross (2000) found that 49 percent of adults who saw DTCA felt that it provided enough information to let them know what the drug was for and 50 percent felt there was enough information on risks and side effects. Wilkes et al. (2000, p. 112) found that half of the patients surveyed believed incorrectly that DTCA required government approval before advertisements could be used and that only completely safe drugs could be advertised.

discussion of risk information about the product: FDA suggest that the firm should provide a direct hyperlink to a website, PDF, or similar electronic resource that is devoted exclusively to the communication of risk information and does not contain any promotional material. The draft guidance states that the FDA will not object to the use of URL-shortening services, however URL should not be promotional in content or tone.

Recommend a strategy for communication with Get Well Drugs in order to determine if the drugs supplied by this manufacturer are within benchmark standards set forth by the FDA.