Reasons for Companies' Refusal of Pre-Approval Drug Access- Alleviare India

 

After the passage of the Right to Try legislation in the US, the hope was that desperate patients would have easier access to investigational products outside of clinical trials. If you are looking for a NPP Consulting Company then Alleviare Life Science Pvt. Ltd. However, companies still have the legal right to refuse providing unapproved drugs to patients. This article explores the reasons why companies might decide against pre-approval drug access.

Resource Limitations:

Some companies lack the necessary resources to accommodate requests outside of clinical trials. Insufficient investigational product availability or limited internal capacity, including time, finances, and personnel, can pose challenges in managing and regulating pre-approval drug access. The potential strain on resources, especially considering the ease of patient connection through the internet and social media, may lead companies to avoid such access altogether.

High Risk Outside Clinical Trials:

The use of investigational drugs outside clinical trials is considered higher risk due to the absence of tightly controlled settings. Patients accessing medicines through Expanded Access or Right to Try utilize them in everyday life, increasing the likelihood of product misuse. Additionally, patients ineligible for clinical trials, often due to disease progression or concomitant medication use, may be more prone to experiencing unrelated serious adverse events (SAEs).

Impact on Drug Approval:

Companies are concerned that adverse events experienced by patients accessing medicines through Expanded Access or Right to Try could reflect negatively on their product and potentially hinder drug approval. While reporting SAEs is only required if a causal relationship is established, manufacturers may avoid the perceived risks associated with pre-approval access to ensure regulatory approval and recoup their research and development investments. Prioritizing drug approval allows wider availability to patients not enrolled in clinical trials.

Conclusion:

Companies may refuse pre-approval drug access for various reasons, including resource limitations, higher risk outside clinical trials, and concerns about the impact on eventual drug approval. Balancing patient needs and regulatory requirements, companies make decisions to ensure the successful market launch of their drugs and broader patient access while minimizing potential risks.