RSC Management Pros & Cons Drug Approval Process Discussion Responses
Please respond to all of the 3 peers discussions post. These need to be in APA format with references and be at least 400 words in lengthOriginal Question
Discuss the pros and cons of the FDA drug approval process, in particular the fast track process. Are new drugs too expensive?
Here are links to a couple of articles to help you with this discussion topic:
https://Links to an external site.
www.wsj.com/articles/fast-track-drug-approval-designed-for-emergencies-is-now-routine-11562337924Links to an external site.
In case you can’t read this from the link (I have a subscription through ASU, but could read without signing in), here is the pdf: Fast-Track Drug Approval, Designed for Emergencies, Is Now Routine – WSJ.pdf
And here is a link to an article.Links to an external site.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4936080/?Links to an external site.
When a person goes to the doctor due to an ailment, they trust that the medication their doctor prescribes is safe and effective. The medication would not be approved by the U.S. Food and Drug Administration (FDA) if it was not safe and effective, right? But this is not always the case when it comes to drugs that are approved using the fast-track approval process. In 1988, a law was passed that allowed the FDA to fast-track the approval of promising medications, even if they have not been studied in Phase 3 clinical trials (Darrow et al., 2020). This approval process is meant to expedite the approval of life-saving treatments for diseases that do not have any other treatment options available (Darrow et al., 2020). Fast-track approval can be quite risky because the safety and efficacy of a medication is assessed by using surrogate measures instead of data collected from Phase 3 clinical trials (Darrow et al., 2020). This means that over time, it may become clear that these fast-tracked medications are not as safe or effective as they were initially thought to be, putting patients that take these drugs at risk for adverse events and side-effects.
Another problem with fast-tracked medications is that they are extremely expensive. Since fast-tracked drugs are meant to meet an unmet need, patients may not have any other options but to take the high-priced medications. But why are these medications so expensive? Pharmaceutical companies are businesses and even if their goal is to come up with innovative solutions to health problems, they also want to make a profit (Wolfe, 2022). Fast-tracked medications are approved by the FDA, despite a lack of clinical trial data. As more data is collected, it may be revealed that the drug is not as safe or effective as anticipated, leading the manufacturer to pull the medication off the market (Darrow et al., 2020). The risk of a fast-tracked drug failing means a company might have a limited profit window to recover research and development costs, leading to high drug prices (Darrow et al., 2020). Additionally, the FDA has fees that companies must pay when they utilize the fast-tracked submission process (Darrow et al., 2020). Some speculate that drug costs for fast-tracked medications are increased so that companies can cover the cost of the FDA fees (Darrow et al., 2020).
While it is easy to point out the flaws of the fast-track approval process, it is also important to highlight the system’s benefits. This process enables companies to bring life-saving treatments to patients in need. Even though time may reveal that some fast-tracked medications are not as safe or effective as anticipated, others might be better than expected. If a medication can save lives, perhaps the high cost and potential risk of fast-tracked drugs is worth it.
Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2020). FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA : the Journal of the American Medical Association, 323(2), 164–176.
Wolfe, S. M. (2022). Curbing the Financial Incentives That Contribute to the High Prices of Prescription Drugs in the US. JAMA Internal Medicine.
Pros and Cons of the FDA drug approval process, in particular the fast track process. Are new drugs too expensive?
Over the course of many decades, the majority of medications for life-threatening conditions were required to complete an extensive battery of tests before being approved for sale (Loftus, 2019). A more limited number of them were “fast tracked” so that patients could get their hands on them more quickly. Now that the dynamic has been reversed, the majority of pharmaceuticals are made available more quickly than ever before because of government initiatives that expedite their clearance (Loftus, 2019). The critically sick, particularly those who have exhausted all other treatment possibilities, are seeing a shift in how medical decisions are made as a result of the new normal. These programs provide the FDA’s approval to pharmaceuticals for patients who the agency deems to have a high need for them. Often, these individuals suffer from conditions that are fatal or disabling and have few or no therapies (Loftus, 2019). In most cases, regulators are acting in response to demand from drug manufacturers, physicians, patients, and policy makers to speed up the process of bringing new pharmaceuticals to market (Loftus, 2019). The approval will often depend on indicators of promise in early research rather than on studies that were conducted for a longer length of time, or it will follow a shorter evaluation period by authorities from the FDA (Loftus, 2019).
A shift in the level of proof required for a drug’s effectiveness is occurring concurrently with the acceleration of the drug approval process. Regulatory agencies are placing a greater emphasis on surrogate’s indicators, which are other measures of a drug’s positive impact, such as the shrinkage of a tumor, rather than evidence that a drug improves a patient’s survival in life-threatening diseases (Loftus, 2019). After a medicine has been released into the market, it is hoped that thorough evidence that a drug really works will become available. As a consequence of the fast-track process, pharmaceuticals are being introduced to the market with an ever-decreasing amount of supporting evidence (Loftus, 2019). As a result of this, public and private insurers are footing the bill for costly treatments that are ineffective, and patients are occasionally put in a position where they are exposed to unneeded costs and side effects. Patients on Medicare, those who are underinsured, and others may find up paying significant out-of-pocket costs for unsuccessful therapies, despite the fact that insurance normally covers the majority of the cost of the patient’s medications (Loftus, 2019).
Loftus, P. (2019). Fast-Track Drug Approval, Designed for Emergencies, Is Now Routine – WSJ.
The Food and Drug Administration (FDA) drug approval process is lengthy and complex. Usually, if the FDA grants a sponsor approval, this means that there is substantial evidence that confirms the drug’s ability to provide benefits that outweigh the associated risks (FDA, 2022). The FDA, however, encourages the development of certain drugs that (1) have indications for illnesses in which patients have no alternative treatment option or (2) have the potential to outperform alternative treatment options that may be currently available to patients (FDA, 2022). These developments are encouraged in the form of designations. The developmental designations are strategic and intended to address specific medical needs the community may have. The three designations include fast track, breakthrough therapy and priority review (FDA, 2022).
The fast track designation was designed to: “facilitate the development and advance the review of drugs that treat serious conditions, and fill an unmet medical need, based on promising animal or human data” (FDA, 2022). Sponsors may apply for this designation when they submit an investigational new drug (IND) application. If the FDA chooses to grant the assignment of the fast-track designation, the FDA can approve the drug after reviewing a single phase II study (Chary, 2016). There are several factors to weigh when considering whether this designation is helpful or hurtful to the patients subsequently consuming these newly marketed drugs. On one hand, the fast-track processing of drugs: (1) facilitates earlier access to patients that have no alternative treatment options, (2) can be applied to drugs that address a wide variety of life-threatening conditions, and (3) provides a foundation for which other drugs for the same indication can eventually move into the market. On the other hand, however, the fast-track processing of drugs can: (1) lead to the marketing of drugs that lack efficacy, (2) cause severe and unanticipated adverse events to occur within the targeted patient population, (3) lead to potentially severe long-term issues that alter a patient’s quality of life, and (4) leave patients that can’t financially afford the new drug without a treatment option (Chary, 2016).
Personally, from a functional standpoint, I do think that the fast-track approval process is necessary in order to find treatments for patients that may not be able to live long enough to see their potential treatment make it through the traditional review and approval timeline. With that being said, I do agree that the process is flawed and could use guidance and tools to be more effective in safely getting new, blockbuster medications to patients in need. In the re-evaluation of the fast-track process, funding should be heavily considered as many of these drugs may be unaffordable to the patients that desperately need them.
FDA. (2022). Drug development & approval process. U.S. Food and Drug Administration. Retrieved October 13, 2022, from
Chary K. V. (2016). Expedited drug review process: Fast, but flawed. Journal of pharmacology & pharmacotherapeutics, 7(2), 57–61.