Examination of cancer drug approvals shows FDA is faster than EMA, disproving an ‘urban myth’
Monday, July 11, 2011
It has been a long-held belief that European regulators are willing to take more innovative approaches to ushering drugs through the regulatory process. And several recent reports have criticized the FDA for being inefficient in its approval process for medical devices compared to the European Medicines Agency (EMA). Complaints about cancer drugs being held up in the U.S. regulatory process are particularly widespread.
But it turns out that the numbers don’t back that up. Researchers with the nonprofit advocacy group Friends of Cancer Research culled through data on each of the 35 cancer drugs approved in either the United States or Europe between 2003 and 2010, and found that each of the 23 that were approved on both continents achieved that milestone in the U.S. first. In fact, those drugs became available in the U.S. several months earlier than in Europe.
“What we were hearing was very anecdotal,” said Jeff Allen, executive director of the 15-year-old Friends of Cancer Research and one of the study’s authors. “That’s why we did the study—because no one could produce the actual evidence” of cancer drugs being approved in Europe first.
The difference in the timing of approvals was attributable to two factors, said the authors. First, they found that pharmaceutical companies typically submit their clinical findings to the FDA prior to submitting them to the EMA. Second, they found that the FDA consistently took less time than the EMA to review a new oncology medicine. The FDA review period was close to six months; in Europe, the median review time was almost a year, at 350 days.
The findings, published online in the journal Health Affairs, come as Republican lawmakers in the U.S. House of Representatives jockey for deep cuts to the FDA’s budget. The study’s authors said their results show the need for Congress to adequately fund the FDA.
FDA Commissioner Margaret Hamburg said in a statement that the findings “reflect FDA’s commitment to foster access to effective therapies in a responsive and timely manner.”
Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the FDA, said the agency was “not in a race with other regulatory agencies,” but that the cancer drug findings could help eradicate an “urban myth” that the U.S. routinely trails behind Europe on approval decisions.
The authors noted that their results are in line with other studies that indicate the lack of new oncology medicines is due not to slow review processes, but rather to difficulties in carrying out clinical trials in oncology.
Samantha Roberts, science policy analyst for Friends of Cancer Research who previously worked for the FDA, said a third of all drugs examined in the study went through the FDA’s accelerated approval process, a regulation established in 1992 allowing earlier approval of drugs that treat serious diseases and fill an unmet medical need. Regulators in Europe have a similar program that was established in 2008.
Of the 35 cancer drugs reviewed, Europe approved three that did not pass FDA review, and the FDA cleared nine that failed to win EMA approval.