The FDA Effectiveness of Protecting the Safety of Human Subjects

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Generalized Background

Regulations on drug use by Food and Drug Administration (FDA) has become very vast following international reforms, growth in the workforce and in terms of the recommendations arising from statutory requirements. There have therefore been concerns with regard to the implications coming out of the operations carried out by the drug regulation agency’s processes and procedures. FDA has gained esteem as well as essence being one of the global drug regulatory units, whose contribution has been recently called for in decision making processes as well as in deducing oversights into such processes (Sexton et al., 2004). But then, the general public has questioned the FDA’s competency in achieving a unilateral evaluation in reviewing both drug safety and efficacy following the approval which was accorded to them (Alazraki, 2004). There have also been concerns into their delivery in terms of the performance on the basis of normal life situations.

For long, health care agencies have had themselves committed in protecting the general public from the probable drug and/or medicine abuse as well as harms aligned to clinical trials. As per Alazraki (2004), they have also engaged in ascertaining that potential and prospecting practitioners comprehend the possible risks as well as benefits in any given subject of research. An amendment to the United States of America’s Food, Drug and Cosmetic Act in 1960s held that a person had to assent to (at minimum) taking part in any given experimental therapy. But then, some 1967 policy by FDA made it clear that the procedure had to ascertain there is a valid consent which had to be in writing.

Later on, there was established the Office for Protection from Research Risks (OPRR) to make certain people’s safety as well as their welfare. FDA reviewed its stipulations in 1981 in requirement of written consent for all the product related studies for which it forms the regulatory body (Califf, 2003). Presently, the leadership of FDA and some other agencies are in top gear taking part in essential roles so as to ensure an oversight into researches alongside ensuring that the persons involved are protected. Furthermore, FDA has ensured that its responsibilities are shared among and with a number of institutions of research as well as individual research personalities.

Considering these concerns, the question that comes into the minds of many is whether FDA is really effective in protecting the safety of human subjects or not. Califf (2003), notes that FDA has been rendered to be in the fore front in the evaluation of drug safety systems within the country. There is need to enhance such systems by empowering clinical researches as well as researches relating to epidemiology along with actions for regulations as based o upon scientific approaches. FDA has recently been putting more efforts into enhancing decision making processes regarding its post-marketing, but there should be a more comprehensive reaction which incorporates acknowledgement for the need for alertness throughout the processes involving drugs (Evens, 2007). It is proper that public preferences, needs and interests be fully complied to and be offered best when dealing with matters relating both to safety and efficiency. Nevertheless, FDA has not been mindful in the same as these are only limited to itself. It can therefore be justified the FDA has been effective in protecting the safety of human subjects.

Problems and Obstacles

Recently, there have been controversies emerging based on drug safety as leading to perception by the public holding that there is crisis on drug safety system. From this perception, there have developed a prospect for a thorough and detailed assessment and evaluation of the system of drug safety in United States of America (Evens, 2007). Along with the same concerns, there have been instances where there have been queries into the process of reviewing as well as approval processes for drug safety systems. Besides, there have been questions whether FDA has lost its focus to pace up adequacy into the attention which may not be accorded to safety with respect to the efficiency and timely communication or dissemination of relevant information to the public.

Armum (2010), notes that apart from these, there have been questions regarding FDA’s independence in utilizing and relying on scientific expertise. This has become an obstacle since it has led to conflict of interest from within FDA’s advisory units. Moreover, there have been queries on possibility of unjustifiable industrial influence regarding funding processes. FDA’s problems reflect its fluctuations based on unstable regulatory approaches (Baker, 2009). There is complexity in the reality behind FDA since no real documentation has been carried out on whether there is crisis on drug safety on not thereby probable drug safety obstacles cannot be figured out from the agency’s information on the existing systems on drug safety.

It has otherwise been noted that FDA’s relationship has improved in the recent past years by offering enhanced directives and guidelines concerning its expectations. Gad (2006) observes that this has been observed since the endorsement of its 1997 Act on Modernization. Quite a number of companies have also welcomed FDA as per its focus towards integrating its feedbacks into developments on products (Loftus, 2010; Gad, 2006). Even though there have been some companies which have deemed FDA as frustrating by changing its positions over the review processes, it has been widely viewed by some as getting to meet with FDA well before submission of review tools has enhanced their application standards as well as quality (Califf, 2003). Nonetheless, some of the companies’ products have been in the past rejected following FDA’S inadequacy in its resources for review processes while a minute number of the companies feel that FDA is doing little in advancing personalized drugs and/or medicine and therefore lacking in competency to execute the intended initiatives (McKee, 2010).

In spite of some stipulations from life-science companies, the public is however contented with FDA’s level of performance. This is so even with consumers’ depicting its improvement. Actually, a majority of the consumers are very satisfied of the safety and efficiency of both medical and drug devices as recommended for use in America, with an even bigger number agreeing that the country possesses the overall best standards globally regarding drug effectiveness as well as their safety (Baciu et al., 2007). A further larger number is also confident that FDA examines the safety and effectiveness of drugs upon their approval and release to the public for consumption.

Proposed Solutions and Methods to Overcome Obstacles

To overcome the obstacles and problems addressed, there are supposed to be new initiatives towards enhancing the safety of drugs and medicine. This can be achieved or realized by enacting policies which integrate new resources into the medical as well as drug related safety concerns. Besides these, there should be regulatory instruments as well as authorized bodies or units to ascertain that the use of drugs and medicine is both safe and appropriate (Alazraki, 2010). This furthermore will call for sponsorship to ensure that there are changes in safety-related labeling of products. In addition, there is need to establish the potential risks in assessments as well as prevention approaches for the risks related to drug and medicine necessary for verifying the benefits in a drug which actually surpass the drugs’ risks (Califf, 2003).

There is need to formulate methods for acquiring access to relevant information from reliable sources. In addition, there should be developed risk identification strategies and systems for analyses to relate health associated data gathered from various sources. This should actually concentrate on developing and executing systems that incorporate electronic systems for the role of monitoring medical products safety (Richard, 2009; FDA, 2004). Moreover, this will ensure there is competency in having new drugs and medicine in an effective and safe qualities.

To ensure an oversight that is effective, especially with the rise in the number of entities taking interest in clinical research which is also becoming quite complex, there is need to sustain the integrity of research by all means. This should also be considered with regard to the need to further improve the existing protections for the human subjects.  Reyes (2010) suggests that many new efforts should be developed to enhance research on human safety so as to further empower the oversight of the government regarding research on medical disciplines as well as to strengthen the responsibilities of clinical researchers into abiding to the guidelines given by the federal authority.

There should also be established a process to make efforts for the enhancement of assessors’ clinical education and training. FDA should consider looking into the an approach that will; ensure that it works mutually with the other agencies so as to ascertain that every clinical assessor, administrators in the research areas and any other staff and members affiliated to the agency and its affiliate agencies are given proper research induction into both human subjects and bioethics researches (Reyes, 2010).

Proper consultations by FDA with other relevant agencies should also be considered in guaranteeing specified directives for well informed approvals as well as consistent auditing for confirmation on compliance as regards research institutions (Baciu et al., 2007). Regarding intricate clinical trials which also pose as risky, FDA should consider incorporating observations from other agencies so as to reaffirm the consents of all the bodies involved in any given trial-based occurrences that may further influence how they respond towards taking an active part in the trials themselves.

On the concerns of monitoring, FDA should consider looking for investigation personnel to assist in conducting the clinical trials with detailed plans for monitoring. These monitoring plans should also be made sure that they are shared out with the other agencies, by the selected investigators. Furthermore, FDA should supply a framework of guidelines that will define inter-agencies relationships as well as what they are expected of  in respect to issues of privacy, functional issues, membership qualifications, their roles and autonomy (Richard, 2009).

Though there is a process of streamlining FDA’s systems of assurance on institutions dealing in research, the agency needs to issue new regulations to accord applications for grants permission to suspend certain reviews on the proposed research procedures (FDA, 2004). This should be allowed to be till such a time that these applications have been completely documented and approved for submission.

It has been noticed that there exists conflict of interest and to tackle this, there is need to integrate another directive and/or regulation to assist in verifying FDA’s policies relating to the same.  Along with this, there should be forums to help in establishing strategies for managing conflict of interest in order to ensure that research subjects are aptly advised. This will also ensure that any results related to research work are appropriately analyzed and their presentations confined within the set objectives. Besides, this will help FDA and the other agencies work mutually in formulating fresh regulations and policies on drug safety and human researches for any clinical trials. As Baciu et al., (2007) observes, even though FDA has the authority to issue cautions and/or obliges sanctions to close down any research work up to a moment that any posing problems have been put right, it should consider enforcing financial penalties as a significant instrument in approving institutions of research, those responsible for sponsorship initiatives as well as research personalities who fail to adhere to federal directives. This will further be ascertained if FDA partners with a number of other agencies in enforcing such proposals.


Food and Drug Administration works to ensure there is uniformity in accessing drugs, especially with respect to safety concerns so as to ascertain there is a well and proper protection of the human subjects within the entire public health domain. Even though FDA faces patients of a diverse scope, it is has a complicated set of tasks in response to drugs as well as a umber of products as used by the patients (FDA, 2004). Though there may be limitations and obstacles in the regulatory systems of drug safety and/or severely negative cases which render individuals fail to sanction the drugs, the approvals by FDA are not a representation of safety and proficiency which are guaranteed for entire lifetime. Therefore, even with the best systems for drug safety are not able to curb negative responses within the market setting.

Getting a proper comprehension of the risks of drugs as well as the benefits that come with drug use is a significance that advances following measures put in place to guide drug safety systems and procedures. Members of FDA and its staff as well who are responsible for revising FDA’s policy submissions have been able to find a strong base in integrating both the benefits and the risks relating to drug safety before any approvals can be put in place (FDA, 2004). All in all, FDA has been and still is effective in protecting the safety of human subjects.