The easiest commodity to buy in a developed nation in the early stages of economic development should be drugs. However, due to administrative limitations that result in the stalled process of getting drug approval into the market, this is not the situation in the United States. The Food and Drug Administration is at the center of a divisive movement to change regulatory law so that pharmaceutical companies can speed up the approval of manufactured drugs and their introduction to the market. Contrary to this, objectors stand against the process due to the cautionary steps that are required for drugs to be approved and introduced into the market. As such, the question of whether the Food and Drug Agency should speed up the process in drug approvals come into play. Therefore, the paper aims to discuss on the proponents from an explorative end on what proposed issues are presented about the FDA speeding up the process.
Why the Issue is Important in the Current Era
The rhetorical situation about the need for the Food and Drug Agency to speed up the process is that numerous people are interested in knowing what issues underline the expedition of the process. The need to speed up the process is based on the fact that the President, Donald Trump, campaigned on the need to improve on the process through which the Food and Drug Agency approves the drugs into the market. The reason is that in the United States of America there are fewer drugs on the market that are necessary for the increasing number of sick people in the country. However, the attitude towards the issue has been found both with critiques and accolades on the campaign to increase the pace at which the drug approval is done in the country.
First Opinion: Improved Medical Therapy Delivery
According to Fox (2017), the point in place is that the FDA does possess the capability to speed up the process. About her article on FDA, the Fox points out that the United States of America is already expediting the process faster than any other continent such as Europe. The reason is that the country has streamlined methods that improve the speed at which drugs are processed. There are four mechanisms through which the Food and Drug Agency speed up the process include fast-tracking, breakthrough therapy, accelerated approval as well as priority review (Fox).
Second Opinion: Loopholes in the Process
On one end, the FDA’s speeding up the approval has been embraced with numerous accolades including the President’s support. However, on the other end, there are skeptics on the loopholes that maybe looked over in the process of introducing drugs into the market. According to Toopol (2004), health risks associated with the speedy introduction of drugs into the market may be augmented. In one case scenario, in 1999, Merck was approved by the FDA (the Food and Drug Administration) to introduce rofecoxib and made up to $2.5 billion. Regardless, the business extracted the drug after risks of myocardial infarctions and strokes were reported (Topol).
Additionally, another concern is based on the technology that is being used to improve on medication. For example, according to Volk, there are proponents that there might be a breakthrough in the regeneration of organs in humans just as it happens in amphibians. The concern in this area is that due to the complexity of the improvement in medicine and humans, the process may be riddled with unprecedented loopholes which may cause additional health issues in humans. In other words, the expedition in the particular process, as shown above, may increase chances of approving non-therapeutic medical treatments (“Has the FDA Seen the Light on Expediting Its Drug-Approval Process?”).
Third Opinion: Speeding Up Means Slowing Down Evolution in Medical Therapy
In another event, according to Healy (2017), the need to expedite the drug approval process may limit the procedures that are required to approve a drug. Most of the methods require recruitment of volunteers also known as testees who would improve on understanding whether the drug would work or not. In the quest to expedite the process, it may be difficult to get the right volunteers in a short period. To make matters worse, according to Healy, is that the methods that have been unmeasured, the pharmaceuticals may cut corners on specific procedures such as medical trials. According to Healy (2017), there are more than 174 drugs as well as biologic therapies that were approved between January 2016 and December 2016. The issue about this is that there was no regard for the long-term effects that the drugs would have on the users through medical trials. The probability that the drugs may have long-term effects may be worse for the future than it is now (Healy).
Nonetheless, according to De Rugy (2016), the need to speed up the process has been more integrative than it has done in the past years. As such, it has made it possible for people who are sick to get the medication as fast as possible rather than wait for an extended period. The idea to this is to speed up the slow process that the Food and Drug Agency has on the drug approval process. But, on the other hand, there is an issue to speeding up the process when it is concerned with drugs. The problem, in this case, is that the FDA process may be inefficient in solving the evolution of medical therapy. It may render the process less risk-averse due to the need to speed up the process in approval of drugs (Elsevier).
Moreover, the issue is that the speeding up the process of drug approval may render the support of generic medications faster compared to other original drugs. According to Silverman (2015), the congressional approval on the need to speed up the process may induce the increase in support for the generic medicines which may have detrimental effects on the users in the long run. It may limit the standards that the Food and Drug Agency that have been set for years to lesser limits (Silverman).
Conclusion
The issue of the need to accelerate the process of endorsement of medications under the Food also Drug Agency has set up mixed reactions to the endeavors. It may cause more negativity than positive accolades due to the literature that has been studied in the paper. However, there might be more favorable if the issue is looked at in-depth to understand what merits lay within. Nonetheless, the paper has demonstrated that the point of FDA’s need to speed up the approval of drugs will be a contentious issue for an extended period.
Work Cited
Elsevier, Name |. FDA Speeds Up Generic Approval Process. https://pharma.elsevier.com/pharmacovigilance/fda-speeds-generic-approval-process/?fsdsd=efwe. Accessed 5 Dec. 2017.
“Engineering New Organs Using Our Own Living Cells | DiscoverMagazine.Com.” Discover Magazine, http://discovermagazine.com/2015/march/13-the-doctor-and-the-salamander. Accessed 5 Dec. 2017.
Fox, Maggie. “Trump Wants Faster, Cheaper Drugs but FDA Is Already Fast, Experts Say.” NBC News, 1 Feb. 2017, https://www.nbcnews.com/health/health-news/speed-drug-approvals-fda-already-did-n715481.
“Has the FDA Seen the Light on Expediting Its Drug-Approval Process?” National Review, http://www.nationalreview.com/corner/429206/fdas-drug-approval-process-will-it-continue-speed. Accessed 5 Dec. 2017.
Healy, Melissa. “FDA’s Program to Speed up Drug Approval Shaved Nearly a Year off the Process.” Los Angeles Times, 5 Dec. 2017. LA Times, http://www.latimes.com/science/sciencenow/la-sci-sn-fda-expedited-drugs-20171205-story.html.
Silverman, Ed. “Speeding Up Drug-Approval Process Could Have Downside.” Wall Street Journal, 28 May 2015. www.wsj.com, http://www.wsj.com/articles/speeding-up-drug-approval-process-could-have-downside-1432857506.
Topol, Eric J. “Failing the Public Health — Rofecoxib, Merck, and the FDA.” New England Journal of Medicine, vol. 351, no. 17, Oct. 2004, pp. 1707–09. Taylor and Francis+NEJM, doi:10.1056/NEJMp048286.
