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The Impact of FDA Layoffs on Drug Safety & Shortages

Scripta


The recent workforce reductions at the FDA could significantly impact its ability to effectively manage the safety, efficacy and availability of pharmaceutical drugs.

 

Let’s take a closer look at how these layoffs affect how the FDA operates and, in turn, patient health and out-of-pocket expenses:


Slower Drug Approval Process 


The agency plays a crucial role in determining which drugs can go to market and are approved for public use. With a reduced workforce, the FDA may struggle to keep up with the increasing number of drug applications. This could lead to delays in the approval of life-saving medications, especially in urgent therapeutic areas like cancer or rare diseases. Patients who rely on those treatments could be waiting much longer and put their health at even more risk.


Increased Risk of Safety Oversights


The FDA’s ongoing surveillance of drugs once they reach the market is extremely critical to identifying potential safety issues. The layoffs could reduce the number of staff members who are responsible for monitoring adverse drug reactions and analyzing safety data. This could delay the identification of harmful side effects, increasing risks for patients.


Challenges in Addressing Drug Shortages


The FDA’s ability to resolve drug shortages depends on its staff’s ability to track supply issues and work with manufacturers to find immediate solutions. Workforce cuts could slow down the agency’s response to critical drug shortages, which could lead to treatment delays, poorer patient outcomes and increased healthcare costs.


Decreased Crisis Management Capacity


In times of public health emergencies such as the COVID-19 pandemic, the FDA plays a huge role in approving the necessary treatments and vaccines and managing shortages. A reduced workforce could hinder the agency’s ability to respond quickly to public health crises, compromising public health outcomes.


How Plan Sponsors Can Navigate the FDA’s Challenges


As the FDA faces staffing challenges, plan sponsors need to support their members’ health outcomes with pharmacy navigation tools Scripta. These tools can help identify alternative therapies for medications that are in short supply, ensuring patients continue treatment without significant interruption.

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Scripta™ is neither a pharmacy nor a doctor. The benefit service does not tell you what drug to take and does not participate in the drug selection process. Only your physician can determine the medications that are right for you. These alternative medications are options for less costly drugs that physicians may prescribe in place of the medications you are taking now. Scripta has reviewed your current medications only for the purpose of identifying potential cost savings for you to consider with your physician. Scripta has not analyzed the effectiveness or other therapeutic aspects of these medication alternatives. Accordingly, this report and any other forms of communication received from Scripta are not, nor should they be interpreted as, any form of treatment, drug regimen review, or provision of counseling or consultation by a prescriber, pharmacist or pharmacy. Do not stop taking your medication, change your medication, or start taking a new medication without being directed to do so by your physician and filling the prescription under the oversight of a licensed pharmacist. The alternatives set forth above may not be equivalent to your current medication, may interact adversely with your other medications, may not be indicated in light of your other conditions, may cause different or severe side effects, or may be less effective at treating your condition. Medication prices are approximate based on information provided by your pharmacy benefits manager, insurance plans, and/or employer, and may vary from pharmacy to pharmacy. Check with your insurance plan to obtain a full list of pharmacies where your prescriptions can be filled. All information herein is HIPAA protected, treated as highly confidential, and never shared with your employer.

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