Why FDA Is Suggested a Dilapidated Underperforming Organization - Research Paper Example

A Literature Review on FDA The FDA has come under scrutiny in the recent years with a number of drugs being criticized after they were approved. The institution has been described as “a dilapidated underperforming organization” and suffers serious scientific deficiencies and therefore unable to meet its regulatory responsibilities (Wechsler 18). This comes from a report that described the institution as unable to do its functions given the rising number of cases of drug recalls. The report established a number of major findings. First is that the FDA cannot fulfill its mandate because its scientific base has eroded and its scientific organization structure is weak. Second, the institution lacks in terms of workforce and does not have the capability and capacity to fulfill its mission. Third, that its information technology is inadequate and therefore it is unable to process and integrate a greater amount of scientific information, something which is crucial to its mandate. These factors, the subcommittee concludes make the institution unable to carry out its job as expected and that safety issues will always be there if something is not done (Subcommittee on Science and Technology 3-5). Miller on the other hand notes that FDA’s recent remarks that a company has to ensure the safety of the drug before it can bring to the attention of FDA as bad. What this means is that FDA is encouraged to look at the certification and the process of the drug manufacture and may not carry out individual test on the drugs and thus cause safety issues. The problem is that some of these mistakes go unnoticed more so if no one is complaining and it may take a long time to detect adverse effects on the population unless the drug reactions with the patients are immediate. This shows that the institution is encouraging ethical responsibility of the drug manufacturers and not insisting on individual tests, which is not safe for the nation (Miller 163). Just like any other federal institution, politics have played a center role in the appointment of FDA officials. More is seen in the political administration of the institution than the safety of citizens. Legislators put pressure on the institution as they determine what happens there. Most often the political class interferes with the operations of the body (Wechsler, FDA faces Multiple Challenges). In the year 2005 for example, legislators had to put Crawford’s nomination on hold as they sought to pressure FDA to take action on pet issues. Some senators for example were for the idea that the FDA should approve the “Plan B” contraceptives to be sold over the counter while others pressed the FDA for broader drug importing. Therefore from this it is possible to conclude that the FDA at time has to contend with the pressure from the political class. It has to make decisions that are not based on scientific or medical evidence but on the decisions that are made by the legislators. Failure to do this often leads to wrangles within the institution leading to politically motivated decisions that compromise the safety of citizens (Wechsler, FDA faces Multiple Challenges 32). The relationship between the FDA and pharmaceutical companies is very cozy. This is because it has taken the responsibility of reacting to safety issues when they emanate and not ensuring the drugs are approved for use by the population. Essentially the process of drug approval takes a very long time with the many scientific test that have to be made and clinical trials that the drug has to undergo to ascertain its safety. The problem is that manufacturing firms will lose if the whole process has to be followed. On the other hand if the process is strictly followed the drugs will be very expensive for the people to buy (Dentzer). Therefore a compromise has to be reached and the FDA may only have a look at the process of the drug manufacture and certify it. Mechanisms need to be established so that the FDA is able to balance its duties well or else the problem of drug recall and deaths will continue. Companies are in business to make money and some do not follow ethical considerations in the design of these drugs and therefore if there is a failure by the drug regulation body to look at these drugs problems will always recur (Dentzer). Miller notes that FDA drug approval over the last few years has been disappointing. In 2007 there were only 18 new medicines approved representing the lowest figures in the century. 2008 and 2009 were 24 and 25 respectively. These figures are said to have been caused by the tough measures that are being put in place to ensure drug safety. However even with these measures safety is not guaranteed. FDA has been in the news in a controversy that is linking it to antidepressants and the suicidal thinking and behavior which was found in some teens and children. It was established the regulatory body downplayed some of the scientific concerns and was too slow to warn the public on the effects the drugs had on children and teens thus increasing the risks involved in taking the drugs. A more recent drug under scrutiny a few years ago was Vioxx, a blockbuster painkiller (Dentzer). Study findings indicated that the drug was responsible for increased heart attacks and stroke. The FDA downplayed the whole idea after it had approved the drug until the company that used to manufacture the drug Merck pulled it off the market. David Graham one of the FDA safety officers said in an interview that the FDA as it is currently is incapable of ensuring America’s safety against another Vioxx. He continued to say that the FDA and the Center for Drug Evaluation and Research are broken (Dentzer). Others say that the problem is due to the different scientific views within FDA and its structure that makes the review and evaluation process difficult (Dentzer). A study by reported in the archives of internal medicine between 2005 and 2009, there were 113 recalls by the FDA that the institution determined could cause serious health problems or even death. The FDA agreed that only 21 of the recalled 113 medical devices had been approved through the more rigorous premarket approval process (PMA). Eighty of the devices were cleared through the 510(k) process and an additional 8 were exempted from any FDA regulation (Zuckerman, Brown and Nissen 6-7). Of the recalls, the cardiovascular devices had the highest recall category with 35 of the high-risk recalls. Fifty one percent of the high risk recalls were in the 5 other device categories: the general hospital, anesthesiology, clinical chemistry, neurology or ophthalmology. The study established that the recalls were cleared through the less stringent 510(k) process or were exempted because of the perceived low risk involved. This is rather astonishing given the funding that the institution gets to conduct its activities (Zuckerman, Brown and Nissen 6-11). The FDA needs reforms if the institution has to guarantee safety and increase public acceptance of its duties. The perception of the public about its activities is low because of the many problems that the institution has caused. An online poll conducted in 2006 established that at least six in ten adults gave the agency a negative rating on the function they considered important: ensuring the safety and efficacy of prescription drugs (Arnold 30). About eighty percent said they were very concerned about the ability of the agency to make independent decisions that will make sure that patients have access to safe and effective medicines. When the respondents were asked to rate FDA in terms of how good the FDA was doing its Job, 58% said fair or poor while only 36% said good or excellent. This poll shows the extent to which the public is concerned about the activities of FDA and how their decisions impact on people’s lives (Arnold 30). The history of the FDA has been built on reactive legislations in response to disasters. Three scandals can be identified from which the FDA reacted to: sulfanilamide scandal in 1938, the thalidomide tragedy in 1962 and the recent rofecoxib scandal in 2004. Reforms are need in the agency if any substantial progress has to be made to stop medical calamities. Studies reveal the interference of legislators and inappropriate commercial interference as major areas that need reform to pave way for the independent functioning of the agency. In implementing these reforms the Center for Drug Evaluation and Regulation should be at the forefront for change (Lancet 1211). The institution requires a change in culture, a revamping of its structure in which the issues of safety will be integrated in the life cycle of a drug. It is also important that pharmacoepidemiologists join all drug development committees and the news drug compounds must have a thorough safety review to be conducted at a specified interval not above five years (Lancet 1211). The reforms should also take into consideration the aspect of surveillance to ensure that drugs are safe on the market. FDA relies mostly on notifications of potential adverse effects before it initiates corrective measures which are usually late. The FDA needs to establish a database for proactive Pharmacoviglance to ensure safety (Mitka). 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 FDAs 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