Food and Drugs Administration Regulations plays an essential impact on the pharmaceutical industry by producing a wide range of medicinal products and have distributed throughout the state. The general activity of FDA process of approval has been considered slow and much more expensive to manufactures of the medics’ product. The review process should give the patients’ safety the first priority so as to curb repetition of incident whereby patience got into contact with drugs that harmful to their health. (Bakers, 2009)
In previous occasion FDA neglected their duty of overseeing products getting to the market to be certified standards and as a result patients were supplied with a harmful drug known as Reglan. This means that FDA is surrounded by lots of loophole in the whole process of dealing with the medical device since other company has access to obtain Reglan without undergoing satisfactory review and testing. (Meier, 2008)
Reglan has a variety of negative impacts to the consumer though some of the effects appear differently depending on the body reaction of a patient. This drug has cause most of its consumers to experience a consistent tremor in some of their body parts mostly hands and legs. At different circumstance the consumer gets uncontrolled movement of their muscle especially on the face that is either chewing or even blinking their eyes. (Papp, 2011)
Another common impact of this drug is that it lead a patient to hallucinate, at times became too anxious and to a extreme extend it causes one to into a depression mood making one to even to physically hurting themselves. Critics say, FDA has continued to fail in perfecting its role due to lack of database that is necessary to monitor the entire medical devices so that consumer will be assured of the products in market. (Ben-Shir, 2010)
Baker, D. E. (2009). Current FDA-Related Drug Information - New Drugs Approved By The FDA; Agents Pending FDA Approval; Supplemental Applications Filed By Manufacturer; Significant Labeling Changes. Hospital pharmacy, 43(7), 586-590.
Ben-Shir, R. (2010). Prescription Drugs, Compounds In Development, Clinical Trials, Regulations And Information Sources That Relate To The Pharmaceutical Industry. Journal of Hospital Librarianship, 4(4), 119-128.
Meier, B. (2008). Guidance for the public, FDA advisory committee members, and FDA staff public availability of advisory committee members' financial interest information and waivers.. Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration.
Papp, R. (2011). Information technology & FDA compliance in the pharmaceutical industry. Hershey, PA: Idea Group Pub..