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Drug Development, Public Policy and Trust

The views expressed are those of the author and do not necessarily reflect the views of ASPA as an organization.

By Charles Mason
December 15, 2023

What would you do if I gave you billions of dollars to manufacture drugs? What would I get in return? Each FDA-approved drug costs roughly $2 billion to create. Pharmaceutical companies focusing on drug development produced just one medicinal agent for that amount. Modern drug discovery has many expensive failures. Drug shortages have plagued the United States for over a decade, but the last few years have been the driest. We want drugs free from harmful side effects, so should we examine strengthening United States generic pharmaceutical production restrictions? Should we loosen the process and development cycle? Should we consider how to avert medicine shortages or go on as usual? The pharmaceutical industry faces a complicated mix of competing pressures and industrial innovation trends as COVID-19 continues. The timeline for drug testing and approval is not typical.

Completing all three clinical studies before licensure may take 10–15 years. However, this time varies greatly. Pharmaceutical medication license term depends on several factors. Novel drugs have always advanced medical science and made therapies affordable. Academic-industrial collaboration in drug discovery and development seems essential. Studies suggest industrial cooperation based on new findings should improve academic drug discovery and development. However, the modern medical policy emphasizes rigorous regulation, shorter patent terms and increased generic product usage. To put this in perspective, the FDA approved 48 medicinal medicines in one year. The total cost of producing all permitted drugs was hundreds of billions of dollars. The preceding factors have demotivated and hampered firms’ innovative pharmaceutical research and development. The pharmaceutical industry has experienced increased R&D costs, fewer new drug launches and fewer independent drug discovery pathways. The drug development process involves a team of experts doing several experiments over time.

Food and Drug Administration (FDA)

FDA policy enforcement is responsible for 58 percent of medications in limited supply or unavailability in recent years. This implies hospitals have lost hundreds of drugs in the previous quarter. Nevertheless, despite the significant technological progress throughout several stages of this procedure, there has not been a substantial surge in the number of pharmaceuticals that have received approval from the Food and Drug Administration (FDA). Considering several interconnected viewpoints, we should consider how to examine the impact of government regulatory regulations on pharmaceutical innovation. To comprehend the reasons behind the frequent occurrence of touted breakthroughs that ultimately fail and the persistently high cost of drug development, it is necessary to examine the process involved in addressing an unidentified illness. We must consider the present discourse examining the efficacy of contemporary public policy propositions that foster drug innovation, including patent restoration and other regulatory reform initiatives.

Contemporary Drug Discovery

Academic drug discovery is crucial in modern medication development. All studies that succeeded in phase III, the New Drug Application and Biologics License Application (NDA/BLA), involved academia and industry, demonstrating the importance of cooperation between academic institutions and the pharmaceutical industry. Numerous scholarly research endeavors included the analysis of neoplasms and infectious disorders, specifically investigating small molecules and biologics. The efficacy rates and potential impacts of academic-industrial cooperation differed based on illness domains and medication modalities.

Failure Rate

Despite good strategies, clinical drug development fails ninety percent of the time. Drug shortages are caused by regulatory issues, price and profitability issues and market systems that hinder product branding. This significant failure rate raises questions about missing target validation and medication optimization components. Drug optimization currently prioritizes potency and specificity using structure-activity connection. The FDA isn’t too responsible for shortages but rather one of several issues that have hampered medication companies. To avoid blame, the government is investigating whether the FDA’s medication supply regulation has improved or hurt public health. However, these inquiries have not prevented the institution from ambitious policy executions. Research has regularly revealed prescription medication pricing to be a public health policy issue.

Prescription Medications and Pricing

Key results on popular attitudes toward prescription medications and pricing are at the forefront of this debate. Six in ten persons use at least one prescription medicine, and 1/4 take four or more. Those taking four or more prescriptions face more affordability issues. Compared to one in five persons taking three or fewer medicines, 37 out of 100 of those taking four or more have trouble affording them. Lower-income persons are also more likely to report difficulty affording prescription drugs. Preclinical and clinical research has been funded to improve medication efficacy. Many Americans may choose between purchasing prescription drugs and paying for food or other expenditures due to high medication costs. Cost prevents almost one in three Americans from taking their medication. We must soon overhaul our regulatory and industrial policies to stimulate intense competition in novel pharmaceutical research. Restoring the public trust in the system is essential. The road to success takes persistent work, open communication and ethical principles. The system can rebuild its reputation, credibility and leadership in an age when trust is the currency of success by aligning internal practices with external expectations. The people are watching and waiting.

Author: Charles Mason, Ph.D., is a graduate of Walden University in Public Policy and Administration specializing in Criminal Justice. He is also a graduate of Barry University with an MPA and a graduate of Vincennes University with a Bachelor of Science in Homeland Security and Public Safety. He has over 30 years of experience in security, local law enforcement, state corrections and military service. He is currently president of Mason Academy. He can be reached at [email protected]. Twitter: https://twitter.com/DRCharlesMason

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