Review on the FDA and the Regulation of Drugs - Research Paper Example

Research Review on the FDA and the Regulation of Drugs FDA is one of the government departments that contribute in enhancing the well-being of all citizens. The agency protects human health by making sure that drugs, vaccines and various biological products comply with the recommended health standards. The agency also plays a crucial role on enhancing the America’s counterterrorism capability. In order to ensure that the health of all citizens is not in danger, the agency also contributes in making sure there are effective developments of various medical products. This responsibility helps the country to respond on unexpected public health threats that might occur. Unfortunately, for the past few years, the operations of the agency have not been meeting public expectations. This paper provides detailed information about FDA while trying to answer some of the most asked questions about the agency. Introduction Food and Drug Administration (FDA) is entitled to protect the American citizens’ health. The agency manages to accomplish this obligation by enforcing various safety regulations for various items that tend to relate with public health. Some of these items include drugs, vaccines and other products that are biological in nature of which relate to public health. The other significant issue that the FDA manages to perform is checking on the competency of various medical equipments. Moreover, the agency is also entitled to regulate various tobacco products in order to make sure that they comply with the set health standards. Another area that the agency touches is on helping the public to access the necessary information concerning on how to use various types of medicine and food. The agency also plays a significant role in helping to speed up product innovations. There have been many questions concerning the operations of this agency. Is the FDA doing a good job of monitoring drugs to make sure they are safe? Competency is one of the main questions that many critics have been asking regarding the operation of FDA. Arnold (30) indicated that there is possible evident that the agency is not doing enough according to the expectations of the public. This is after a survey conducted by Harris Interactive Care Poll, which managed to figure out that six people out of ten voted negative for the agency. Most of these people who voted negative indicated that the agency has failed in one of its main role and objectives of ensuring there is safety in all of the prescription drugs (Mitka 1922). Moreover, the poll also indicated that 80% of all the participants who took part in the survey concluded they were very much concerned with the agencies operations (Arnold 30). This indicates that the agency’s operations are questionable. Some of the issue that made this large number of participants to question the operations of the agency includes the fact that it seems to have poor decisions making ability on issues concerning accessibility and effectiveness of safe and reliable medicines (Arnold 30). Another factor that makes it possible to conclude that the agency is not doing a good job is after reflecting the results of the poll on direct questions regarding this issue. The polls indicated that of all the participants that were interviewed, 58% rated the agency either poor or fair on the question of whether it does a good job. Only 36% of the participants indicated that the agency does a good job (Arnold 30). Failure of the agency to do a good job was indicated in another survey conducted by the same company. The survey showed that 61% of the participants that were interviewed said pharmaceutical firms were doing a good job compared to FDA (Arnold 30). The other evidence showing FDA is not doing a good job is the issue of poorly monitored and communicated rofecoxib scandal that occurred in 2004 (Lancet 1211). This was an evident that the agency is not as expected. Moreover, evidence showing that the agency has not been performing a good job is according to the statements made by Rosa DeLauro at the budget hearing meeting (Wechsler 32).She indicated that there were shortages of flux vaccine on that year (2005) (Wechsler 32). Rosa also cited that the agency had been delaying withdraw of drugs such as the Vioxx. Moreover, she cited that the agency had also not been able to enforce animal feed ban in order to protect for the spread of mad cow disease (Wechsler 32). Is the FDA under too much political and industry pressure, and thus “in bed” with the industries it is supposed to oversee? In an interview conducted by Susan Dentzer indicated that FDA is experiencing much political and industrial pressure in relation to its operations. The interviewee, Dr. David Graham indicated that the agency is experiencing harsh conditions. Graham indicated that because of the industrial pressure, the agency and the center for drug evaluations are broken. Another political pressure that has contributed to the failure of FDA in enacting its operations accordingly is lack of funds (Show FDA the money 18). The funds are supposed to be authorized by the Congress of which it has reluctant on this issue. Lancet (1211) indicates that the funds to support the operations of FDA should come directly from general appropriations by the Congress. However, Lancet (1211) indicates that the congressional disbursements have been decreasing since the year 2003. This has made the agency to rely on fees in order to enact most of its operations. The other political pressure that the agency experience regard to its top management system. Most of the politicians have been disagreeing over various issues concerning the management and how things are run in the system. For example, Wechsler (32) indicates that the appointment of Lester Crawford was put on hold mostly because of political reasons. Some of reasons as indicated by Wechsler (32) were just pet issues. For example, some members of the Congress were first wanted the agency to make approval over the counter version of the emergency contraceptive bill, “Plan B” (Wechsler 32). However, other members of the Congress pressed the agency to support of broader drug importing. Some of these political issues among others have been exerting pressure on the agency making it fail to enact its operations accordingly. The other political challenge that the agency have ever experienced was after the incidence of deaths related to Mifeprex (Wechsler 32). The political pressure that the agency experienced contributed to make changes on its top management. Moreover, the agency was supposed to answer various questions related to occurrence of this incidence at the committee that approves the agency’s budget. During the meeting, Wechsler (32) indicates that Rosa Delauro from the Republican Party pressed the head of the agency, Crawford, to support various changes that had been by the legislative regarding the operations of the agency (Wechsler 32). Some of the changes that the legislative had made related to the importation of drugs and their safety oversight. This information indicates that the agency has been experience pressure of the political arena. On the industrial pressure, Lancet (1211) indicates that various competing interests have been exerting pressure on FDA for a long time. Another established industry pressure is the post marketing surveillance. This particular opinion was cited by the Institute of Medicines that stated that little attention has been paid regarding the issue of post marketing surveillance. The other issue relating to industrial pressure entails that the agency has been experiencing an absence of a legal framework. This legal framework ought to contribute much in empowering the Center for Drug Evaluation and Research (CDER) (Lancet 1211). Failure to empower CDER has contributed to the lack of in FDA on enforcing various restrictions (Lancet 1211). Moreover, FDA has been under pressure from pharmaceutical companies that get devastated on the issue of drugs approval. Most of these companies state that, the agency tends to take longer time before approving drugs. Some managers of these companies argue that the failure of the agency to approve the recommended drugs in time may contribute in making major drug organizations to fail in their operations. This is because there will be lack of innovative medicines that health insurers may be having a potential will to reimburse (Miller 78). The other pressure that the agency tends to get from pharmaceutical firms relates to the issue of escalating user fees (Miller 78). The companies indicates that imposed fees by the Congress that they are supposed to pay FDA when in of its services tends to be overcharged. For example, Miller (78) indicates that that a single company is entitled to pay $ 1.2 million tax for the typical drug in the market. This high amount of fees leads to financial risks in these industries. Moreover, this issue contributes in making products critical to most of the potential customers especially those with low income (Zuckerman, Paul & Steven 108). Questionable issues on decisions made by FDA made concerning approval of drugs Numerous questions have emerged concerning the operations of the agency especially on approval of drugs. An example of such questions emerged after the agency allowed the usage of Vioxx that later brought about various complications. Dr. Brian Strom who has been sitting on various committees entitled to advice the agency made a questionable statement when holding an interview with Ray Suarez and Susan (Dentzer n.p). The official said that agency do not do enough concerning public service education. He was making his answer in relation to the Vioxx issue. Brian said that the public fail to understand that all drugs have safety issues (Dentzer n.p). This statement tends to raise various questions regarding the operation of the agency. One such question is that why has the agency considered taking any of its precious time to provide education in relation to dug usage to the public. It is evident that one of the main roles of the agency is to offer provide information to the public relating to various types of drugs but why does it take too long to act. On the same incidence relating to Vioxx usage, Dr. Avorn said that the agency’s system is not working properly. His speech indicated that apart from the Vixx experiences that were other incidences of which gave negative outcomes. This creates a question of why does the agency fail to make corrections from experience in order to avoid future occurrence of such critical problems. Is the FDA an efficient and functioning body, or should the government revamp it? Apart from the above addressed negative issues that depict FDA has not been performing its operations accordingly; the best opinion is that the agency ought to stay. This is because the agency is an efficient and performing body that requires the government to address some of the critical issues affecting it. The government should not consider revamping the agency because it enacts various significant obligations in the country. For example, the agency is crucial for the health of the all citizens in the country. This translates to the fact that the agency is integral to the economic status of the country. The other main reason that the government ought to consider in order to help in supporting operations of the agency is that it protects about 80% of America’s food supply. The agency manages to conduct this service through various regulatory services. This particle issue contributes in many of the countries all over the world to look upon the agency for guidance regarding on how to regulate their industries. It is evident that most of the industries that FDA regulates tend to be the most successful in the country. Moreover, FDA also plays a crucial role in regulating the economic health of the country. For example, the agency regulates approximately $ 1 trillion. Most of the industries that the agency regulates tend to be among the best of which contribute in making a balance trade. The other crucial role that the agency enacts is making sure that the country is secure from various effects like the terrorists attacks targeting health (Subcommittee on Science and Technology.FDA Science and Mission at Risk n.p) Conclusion The above information indicates that FDA is obliged to enact various crucial roles in the country that are related to health. This makes the agency to be of significant importance to the well-being of all American citizens. This means that the country may be at risk if the operations of the agency continue to downsize. Therefore, the government ought to take stiff measures and protect the agency from damaging its reputation. Except for the last couple of years as illustrated in the above information, the agency has been playing a crucial role in making sure that the health of the country is in safe condition. Moreover, politicians also ought to put aside their differences in order to enable the agency to recover and continue performing accordingly. Works Cited Arnold, Mathew. "FDA less Trusted than pharma." Medical marketing and Media (2006): 41(7): 30. Print. Dentzer, Susan. FDA drug screening under scrutiny. 23 November 2004. Web. 4 March 02. Lancet. "Institute of medicine urges reforms at FDA." The Lancet (2006): 368(9543) 1211. Print. Miller, Henry. "The FDA's Imprudent Caution." Policy Review (2010): 161(2010): 73-85.Print. Mitka, Mike. "Report criticizes lack of FDA oversight." JAMA: the Journal of American medical Association (2006): 296(8): 920-922. Print. Subcommittee on Science and Technology.FDA Science and Mission at Risk. Report. New York: FDA, 2007. Print. Wechsler, Jill. "FDA faces Multiple Challenges." Pharmaceutical Technology (2005): 29(9): 32. Print. —. "Show FDA the money." Pharmaceutical executive (2008): 28(1): 18. Print. Zuckerman, Diana M., Paul Brown and Steven E. Nissen. "Medical device recalls and the FDA approval Process." Archives of Internal Medicine (2011): 171(11): 1006-1011. Print. Read More