About Half of the New Drugs Approved by FDA Are Not So by Other Countries
(Thursday, February 16, 2023)
FDA approval of a new drug is often touted as a gold standard for regulatory approval for that drug. However, about 50% of the times, regulators in Canada, Europe, Australia and the United Kingdom, rejected the approval of that same drugs due to insufficient benefit or unreasonable risk. Most of the drugs rejected by other countries were those approved via expedited approval pathways in the US, and many were for cancer. It raises an important question about the FDA approval process; is the FDA too lenient, or that the other regulatory agencies stricter? In the US, the approval of new drugs is a purely scientific question, that where FDA is only allowed to review the available safety and efficacy data in the market approval application. Also, over the last 2-3 decades, numerous incentives were written into the law to provide the FDA with an almost un-challengeable authority to approve new drugs for life-threatening disease and rare diseases, particularly when the data supporting approval is sketchy at best. Once approved, the drugs are automatically covered by payors. According to the research published this week, the early approval of drugs based on limited data by the FDA has not deterred the developers from charging enormous prices for the newly approved drugs; the average price of a new drug introduced in the US is more than $180,000 per year. This is where the approval process in other countries differs from the US. In the UK, Canada, European Union and Australia, drug approvals are done collaboratively by drug regulators and payors. Clinical data in market approval applications is not just reviewed for safety and efficacy evaluations but also comparative clinical and economic analyses. Put together with clinical and economic analyses, the new drug may get a lower score than an existing drug based on no significant improvement over standard therapy or untested risk. The most common reason for rejection is “uncertain clinical benefit, not cost-effective at proposed price”. This pushes the developers to either lower the price of their new drug or get rejected. It is a well-known fact that the US consumers pay the highest in the world for drugs. And it could be because of the payors not having any say in the approval process, like other countries. So, which system is better? There is no easy answer. Just because you can buy it, should you!
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC