News

Study shows that FDA approves cancer drugs faster than EMA

17 Jun 2011

Friends of Cancer Research have announced the release of a study, published in Health Affairs, showing that approval rates of oncology drug products are higher in the United States than in Europe. The study examined the approval rates of new oncology drugs that were submitted to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) between 2003 and 2010.

The study found that:

-  In this time period, FDA approved 32 new anti-cancer drugs while EMA approved only 26.

- FDA not only approved more new cancer drugs than did the EMA, it approved these drugs more quickly: of 23 drugs approved by both agencies, the median time from marketing submission to FDA approval was 182 days vs. EMA approval of 350 days.

- Furthermore, drug companies typically submitted their clinical findings to the FDA prior to submitting these findings to the EMA.

- All 23 of the drugs approved by both agencies in this time period were available to patients in the United States before becoming available to patients in Europe. 

The study can be accessed in full here: http://content.healthaffairs.org/cgi/content/abstract/hlthaff.2011.0231

Source: Friends of Cancer Research