By LISA RICHWINE
The findings released on Thursday
counter a common belief among doctors, academics and investors that new oncology drugs often win approval in Europe first, said researchers from the nonprofit advocacy group Friends of Cancer Research.
Each of the 23 cancer drugs cleared by the United States and Europe over a seven-year period debuted in the U.S. market, the study found.
Drugmakers usually submitted their medicines to the U.S. Food and Drug Administration first, and the FDA review period was generally shorter at around six months. In Europe, the median review time was nearly a year, at 350 days.
“To patients battling cancer, with no treatment options, access to new medicines five-and-a-half months sooner is a very important and potentially life-saving difference,” said Ellen Sigal, who chairs and founded the cancer group.
The findings were published online in the journal Health Affairs.
The researchers analyzed regulatory review times for 35 new cancer drugs approved in either the United States, Europe or both between 2003 through 2010. Twenty-three medicines won clearance in both regions.
Europe cleared three medicines the FDA did not approve. The FDA gave a green light to nine drugs that did not reach the European market. The researchers did not analyze the reasons for the conflicting decisions.
FDA Commissioner Margaret Hamburg, in a statement, said the findings “reflect FDA’s commitment to foster access to effective therapies in a responsive and timely manner.”
The agency has drawn fire from some manufacturers as being too cautious in analyzing cancer and other drugs as well as medical devices.
Some critics say the FDA is harming innovation and U.S. competitiveness with unnecessarily tough requirements. The medical device industry has argued vocally that the FDA is driving companies to Europe where developers see a quicker path to the market. Consumer advocates and others, meanwhile, argue that the FDA may sacrifice safety for speed and should demand more data from companies.
Dr. Janet Woodcock, the FDA’s top drug official, said the agency was “not in a race with other regulatory agencies.”
But she said the cancer drug findings could help dispel an “urban myth” that the United States was routinely falling behind Europe on approval decisions.
“FDA review of cancer drugs is efficient. It’s rapid. The real problems are in the scientific development programs and scientific uncertainty” about how to attack cancer, she said.
For investors, the findings show “there are certain things that are working quite well” in the United States, said Jonathan Leff, managing director of healthcare at private equity firm Warburg Pincus. He pointed to the FDA’s accelerated approval process, a program designed to bring new drugs for serious diseases to the market quickly based on early data.
Investors worry, however, that the FDA will require companies to produce more data to show safety and effectiveness for cancer drugs as the agency has in other areas.
“The fear this is bleeding over into oncology is palpable,” Leff said.
The study’s authors said their results showed the need for Congress to adequately fund the FDA. They planned a briefing for congressional staff on the findings on Thursday. Republican lawmakers in the U.S. House of Representatives have proposed steep cuts to the FDA’s budget.
“Strong public and congressional support is desperately needed for the FDA to continue this trend and to improve its scientific foundation,” Sigal said.
The study was published online by Health Affairs here