During 2003-10, the US Food and Drug Administration (FDA) approved more new cancer drugs, and did it faster, than the European Medicines Agency (EMA), and the drugs approved by both agencies got to US patients more quickly than to Europeans, says a new study.
The FDA approved 32 new anti-cancer drugs during 2003-10 compared to only 26 for the EMA, and the median marketing time from marketing submission to approval for 23 of the drugs approved by both agencies was just 182 days at the FDA but 350 days for the EMA, says the study, which is published in the journal Health Affairs.
Moreover, all 23 of the drugs approved by both agencies were available to US patients before those in the European Union (EU) were able to access them, says the study, by researchers at the Friends of Cancer Research advocacy group.
These findings overturn "repeated assertions" that the FDA is slow and inefficient compared to the EMA, particularly in the field of cancer, say the researchers, who also point out some critics have claimed that the FDA “has become so risk-averse, it is increasingly difficult to obtain approval for effective drugs in the United States."
The study - which examined initial approvals only, not supplemental applications or post-approval decisions - found that pharmaceutical companies typically submitted their clinical findings to the FDA before communicating them to the EMA, that the US agency consistently took less time than its EU counterpart to review new oncology medicines and that it approved more such drugs and biologics during the period than the EMA did.
The improved pace of FDA review times over the last two decades is due in large part to the Prescription Drug User Fee Act (PDUFA) of 1992, which has been renewed every five years since and will be up for reauthorisation again next year. But, say the researchers, user fees are not sufficient to support much-needed advances in regulatory science, nor are they an appropriate source of funds for that purpose.
"Instead, strong public support and additional congressional appropriations are required to move the FDA forward," they say, and, as the next PDUFA reauthorisation draws closer, "it is important to examine critically the successes and failures of the current regulatory process."
Moreover, given the findings of their study, they suggest that "increasing the speed of drug review times might not be as high a priority as achieving other objectives in advancing regulatory science."
• Earlier this year, FDA Commissioner Margaret Hamburg publicly defended the agency against repeated allegations that the FDA's approval rates were inferior to the EMA's. In a letter published in The Washington Post newspaper on February 4, she noted that, out of 57 novel drugs approved by both the FDA and the EMA during 2006-10, 43 had been approved first by the US agency compared to 14 by the EMA. 27 of the 57 drugs were FDA-designated priority-review drugs that provided a therapeutic advance, and all but three of these 27 were approved first by the FDA, she said.
Moreover, the median time from marketing submission to FDA approval had been 183 days for priority-review products and 396 for standard-review products, while in the EU those times were 403 days and 449 days, respectively, the Commissioner added.
Dr Hamburg’s letter noted that the review and approval of new drugs "is not a race between FDA and EU regulators, with whom we collaborate and whom we see as colleagues," and she also pointed out that the two agencies “do operate under different laws and procedures."