Different regulatory bodies have different criteria when it comes to drug approval, especially in the case of cancer drugs. The US FDA tends to be accepting of less-than-certain outcomes and prefers to accelerate cancer drug approvals. However, the use of surrogate markers is not always associated with improved quality of life or increased lifespan. Drs. Kim and Prasad note that access to drugs does not always indicate value.
The authors remark, “The goal of drug policy in all nations is to maximally improve outcomes with every dollar spent. Achieving this may even involve setting higher standards for new drugs at the time of approval. Government agencies with different mandates, such as the FDA and the Centers for Medicare & Medicaid Services, should have clearly defined roles and function independently. Lastly, the US should understand and pay attention to the dynamics of drug approval in other countries. We should consider the possibility that our drug policy has negative repercussions for patients with cancer worldwide.” Read more here.
(Source: Prasad & Kim, JAMA, 2/22/2021)