Other Countries Refused 47 FDA-Approved Drugs in the United States

An investigation published in JAMA Internal Medicine assessed FDA-approved drugs and regulatory decisions made in other countries. In particular, the study focused on regulation and health technology assessments in Australia, Canada, and the United Kingdom. The researchers assessed approval concordance and negative recommendations.

In the US, the FDA is the primary regulatory agency for food, medication, and medical devices. Each year the organization approves an average of 38 drugs, accepting only 12% of drugs submitted for clinical testing. Despite low acceptance rates, the organization has been critiqued for inadequate regulation.

Looking at the 206 new drugs approved by the FDA between 2017 and 2020, the study concluded that less than 79% were approved or granted market authorization by another regulatory agency. According to the study, five drugs approved in the US were denied approval by other international agencies, citing unfavorable risk–benefit assessments. Additional assessments determined that other reasons for not promoting or recommending reimbursement for certain drugs included inconclusive clinical benefits or high costs.

This data suggests that a more rigorous assessment of some drugs for safety and efficacy may be necessary. According to the researchers, most drugs not approved or recommended were approved by the FDA through expedited pathways.

While expedited drug approvals may be helpful in critical cases such as the COVID-19 pandemic, this study suggests that expedited approval pathways in the US are less rigorous and comprehensive than in other countries.

“This cross-sectional study assessed reasons for which drugs recently approved by the FDA were refused marketing authorization or not recommended for public reimbursement in other countries. Drugs with limited international market presence may require close examination by US healthcare professionals and health systems,” concluded the researchers in the publication.

While further analysis of the drugs approved by the FDA and why they were not endorsed or recommended in other countries is needed, the FDA may consider assessing current regulatory protocols.