Fda Research Paper
FDA Drug Approval Process
Tricia Garbuzovas
COM/172
October 5, 2011
Cassandra Baker
FDA Drug Approval Process 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 determines if they are safe and effective before distribution. They do not perform in-house testing themselves; they only evaluate the testing done by the manufacturer to make sure the drug claim is accurate and that the benefits of the medication out way the side-effects (Food and Drug Administration, 2011). Whereas the FDA’s regulation and oversight protects dangerous products from circulation, the approval process hinders manufacturers’ ability to release drugs in a timely manner because of the legal and cost liability, thus preventing the availability of treatment to Americans.
Origins of the Food and Drug Administration The Food and Drug Administration started in 1906 with the passage of the Pure Food and Drugs Act. Use of poisons coupled with poor conditions in meat packing plants causing people to become ill prompted the government to create a regulatory agency to protect the safety of Americans (Howland, 2008). Before the introduction of regulation, consumers had no way of knowing if the food and medications they purchased were safe or effective. According to Howland (2008), during the early 1900s cure-all claims for ineffective and possibly dangerous patent medications was normal. While this was a good start in
Tricia Garbuzovas
COM/172
October 5, 2011
Cassandra Baker
FDA Drug Approval Process 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 determines if they are safe and effective before distribution. They do not perform in-house testing themselves; they only evaluate the testing done by the manufacturer to make sure the drug claim is accurate and that the benefits of the medication out way the side-effects (Food and Drug Administration, 2011). Whereas the FDA’s regulation and oversight protects dangerous products from circulation, the approval process hinders manufacturers’ ability to release drugs in a timely manner because of the legal and cost liability, thus preventing the availability of treatment to Americans.
Origins of the Food and Drug Administration The Food and Drug Administration started in 1906 with the passage of the Pure Food and Drugs Act. Use of poisons coupled with poor conditions in meat packing plants causing people to become ill prompted the government to create a regulatory agency to protect the safety of Americans (Howland, 2008). Before the introduction of regulation, consumers had no way of knowing if the food and medications they purchased were safe or effective. According to Howland (2008), during the early 1900s cure-all claims for ineffective and possibly dangerous patent medications was normal. While this was a good start in
References: Food and Drug Administration. (2011). Development & Approval Process (Drugs). Retrieved from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm Howland, R. (2008, January). How are drugs approved? Part 1: the evolution of the Food and Drug Administration. Journal of Psychosocial Nursing and Mental Health Services, 46(1), 15-19. Retrieved from Retrieved from EBSCOhost Leonard, E. (2009, Summer). Right to experimental treatment: FDA new drug approval, constitutional rights, and the public 's health. Journal of Law, Medicine & Ethics, 37 (2), 269-79. doi:10.1111/j.1748-720X.2009.00371. Philipson, T. J., & Sun, E. (2008, Winter). Is the Food and Drug Administration Safe and Effective? Journal of Economic Perspectives, 22(1), 85-102. doi:http://dx.doi.org/10.1257/jep.22.1.85. Sauer, C., & Sauer, R. M. (2007, October). Is It Possible to Have Cheaper Drugs and Preserve the Incentive to Innovate? The Benefits of Privatizing the Drug Approval Process. Journal of Technology Transfer, 32(5), 509-524. doi:http://dx.doi.org/10.1007/s10961-007-9036-0 .