Key Regulatory Challenge For The Pharmaceutical Sector

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

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

Yes, there is an impact on the pharmaceutical company, like those in the US as a result of differential prices between that country and other nations.

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.

Currently the U.S. Food and Drug Administration (FDA) is responsible for protecting the over all public health of the United States of America (U.S. Food and Drug Administration, 2015). The FDA protects the “public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” (U.S. Food and Drug Administration, 2015). On the Medical aspect, the FDA is involved by increasing new medical innovation to be more effective, safes, and more

The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation” ("What We Do."). One of the most important responsibilities and the topic I will be discussing throughout this paper is drug regulation. The Food and Drug Administration approves drugs that are intended for use in diagnosis, cure, relief, treatment, or prevention of disease, and is intended to affect the function of the body. In order to do so, The Food and Drug Administration reviews drug manufacturer’s via application to put drugs on the market; therefore, a drug may not be sold or marketed unless it has and remains approved by the FDA. Even though a drug has been approved does not mean it will remain on the market, drugs have the likelihood to be recalled. For example, when you see those late night personal injury lawyer commercials saying, “If you have been prescribed and taken said drug, and experienced any of these side effects such as blood clots, seizures, etc., you may be entitled to compensation.” those drugs have usually been recalled due to adverse effects

Specific struggles can occur as possible interventions to mitigate drug shortages are attempted. As discussed above, pharmaceutical manufacturers are private enterprises that are not obligated to manufacture any specific medication even if such medications are in short supply. Purchasing from foreign suppliers is a strategy distributors sometimes use to cope with drug shortages. Authors Dill and Ahn (2014) point out monitoring compliance of foreign suupliers is more challenging than monitoring and regulating facilities in one’s own country (2014). Another approach, used by some distributors, when medications are scare, is to turn to compounding facilities. According to Caulder, Mehta, Bookstaver, Sims, and Stevenson (2015) depending on compounding is a high risk practice. These authors explain that in some cases compounding practitioners do not have sufficient experience and contamination can occur (p. 180). Undoubtedly the most important goal is to avoid distribution of drugs that are contaminated. Using contaminated drug; and a subsequent recall, is the worst possible scenario for all

Chapter 3 (context) described the structure and set up of functioning systems such as the UK and EU medicines regulatory examples that have legal frameworks and policies governing pharmacovigilance within the health system. The existence of a policy containing essential statements of PV indicates that a country is committed to improving the medicine safety giving strong direction for advancement of the systems.

There are many checkpoints to reduce the risk of these medications reaching patients Boards of Pharmacy need to continue to filter out the bad actors (distributers, pharmacists, and non-pharmacist purchasing agents). But the pharmacist is the final gatekeeper. Pharmacists need the tools, financial resources, and time to protect our

Post-approval requirements for recordkeeping and reporting are extremely helpful to monitor the activity of the product. Moreover, the product records are kept in order to constantly control the safety and effectiveness of the product. Post-licensure recordkeeping establish the database with all related documents including adverse events reports, additional clinical trials data, changes in labeling of the products and etc.

There is also a slight issue between consumer and manufacturer as both are in dis-agreement of keeping up with cool chain requirements. This is an operational issue as from an employer and employee perspective their always needs to be a good relationship between manufacture and consumer as the pharmaceutical products needs to have high level in security measures and the manufacturer intrusts the consumer with his products. This is related to another issue found with theft in organisation MISHAIR.

The pharmaceutical industry has been profitable; however, it has been inefficient and the quality of products has been low (Plumb, 2013). Many areas of business and government utilize risk management principles to ensure quality. The International Conference on Harmonisation (ICH) Quality Risk Management guideline (Q9) (2005) states that “it is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm”. The pharmaceutical industry has recognized the importance of quality systems and that quality risk management is an important component of effective quality systems (ICH, 2005). A quality system as defined by ICH Q9 (2005) is the “sum of all aspects of a system that implements quality policy and ensures that quality objectives are met”.

indications, the development of new dosage forms and the strengthening of claims versus the competition (Moss 2001).

Submitted to the Program of Organizational Dynamics in the Graduate division of the School of Arts and Sciences in Partial Fulfillment of the Requirements for the Degree of Master of Science in the Organizational Dynamics at the University of Pennsylvania Advisor: Richard Bayney This paper is posted at ScholarlyCommons. http://repository.upenn.edu/od_theses_msod/33 For more information, please contact repository@pobox.upenn.edu.

The EU clinical trial directive 2001/20/EC, came into existence on 01-May-2004 and literally it has changed the face of clinical trial investigational medicinal product in the UK. GCP was developed by the USA, Europe and Japan at international conference on Harmonisation in 1977. GCP has set of rules and regulations in which important one is the safety, the rights and the wellbeing of humans who are involved in clinical trials. Each person involved in clinical trial should be trained, educated, experienced, updated in GCP and understand the end implication of non-compliance of clinical research. The UK clinical research network was launched in February 2005 and has