The FDA’s Accelerated Approval Program which allows for the fast-tracking of drugs based on preliminary evidence of health benefits; is possibly causing harm to cancer patients worldwide. The program was designed to provide quicker access to needed medications, but it has faced heavy criticism for prioritizing speed over certainty.
FDA Supplements
In Different Cases, the use of this Drug Policy has Proven to be Inefficient.
One example of the consequences of this policy is the case of Atezolizumab, a drug used to treat triple-negative breast cancer. The drug was initially approved through the Accelerated Approval Program in 2019, but a follow-up study found that it made little difference in tumor growth and was associated with lower survival rates (Belin, Tan, De Rycke & Dechartres, 2020). As a result, the FDA indicated that accelerated approval was no longer appropriate and the drug was withdrawn for this form of breast cancer in the US. However, the drug remained approved in other countries, such as India, where the manufacturer continued to promote its use.
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Lack of Coordination Promotes the Negative Consequences of this Drug Policy
Ineffective communication and lack of coordination between regulatory agencies and healthcare providers worldwide is the major cause of this problem. The FDA’s decisions often influence regulatory policies in other countries, and many countries rely on FDA approvals to guide their own regulatory frameworks. This means that drugs approved through the Accelerated Approval Program in the US continue to be prescribed and used in other countries, even after their withdrawal in the US.
The impact of this policy extends beyond the US borders, particularly in low and middle-income countries that often lack their own regulatory frameworks. In these countries, regulatory agencies may rely directly on the FDA’s decisions, which can lead to the use of drugs that have been withdrawn or deemed ineffective. The FDA has encouraged global regulatory cooperation, but nuances and specific details of the Accelerated Approval Program are often lost in the process, leading to misunderstandings and potentially harmful outcomes.
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Clinical Significance
The issue of poor drug regulatory policies raises concerns about the role of professional medical bodies such as the National Comprehensive Cancer Network (NCCN), in influencing clinical practice. Guidelines provided by these bodies can shape treatment decisions and determine healthcare reimbursement. Inconsistencies have been observed in how the NCCN updates its guidelines in response to FDA withdrawals, potentially perpetuating the use of drugs with uncertain benefits (Akhade, Sirohi, Gyawali, 2022).
Experts emphasize the need for improved communication and transparency in drug approval processes. Clinicians and patients often view FDA approval as a definitive stamp of efficacy, without considering the complexities and uncertainties associated with the Accelerated Approval Program.
International Regulatory Bodies and Relevant Organizations must play their Part
To address such a complex issue, several key players must be fully involved and dedicated to the same goal. Manufacturers for example should take responsibility and be accountable to patients globally, ensuring that their promotional efforts align with the latest scientific evidence and regulatory actions.
International drug regulators should consider looking beyond the FDA and the European Medicines Agency (EMA) for guidance. Each country has unique healthcare needs and priorities, and regulatory decisions should reflect these specific contexts.
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Conclusion
There is an urgent need for a more honest conversation about harmonizing drug regulatory systems and improving the transparency and reliability of drug approval processes. The WHO should actively address the problems with established systems like the FDA and work towards a more inclusive and globally focused approach. The goal is to ensure that cancer patients worldwide have access to safe and effective treatments based on sound scientific evidence.
References
Akhade, A., Sirohi, B., and Gyawali, B. 2022. Global consequences of the US FDA’s accelerated approval of cancer drugs. Lancet Oncology. 23(2): 201-203. https://doi.org/10.1016/S1470-2045(21)00709-9
Belin, L., Tan, A., De Rycke, Y., Dechartres, A. 2020. Progression-free survival as a surrogate for overall survival in oncology trials: a methodological systematic review. British Journal for Cancer. 122(11): 1707-1714. https://doi.org/10.1038/s41416-020-0805-y
