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Samantha A. Roberts, Jeff D. Allen, and Ellen V. Sigal, who are affiliated with Friends of Cancer Research, in Washington, D.C., found that the FDA new cancer drugs approval process is consistently faster than the one of its European counterpart. They conducted a drug-to-drug comparison of the two agencies, focusing on the period between 2003 and 2010, and analyzing the data available on FDA and EMA websites on official drugs reviews.
Among thirty-five new cancer drugs reviewed by FDA, thirty-two were approved, twenty of them within 184 days. EMA, on the contrary, approved only twenty-six of these new cancer drugs within a time average of 350 days. “Contrary to repeated public assertions, we found that new oncology medicines are consistently available in the United States before they are in Europe, and they are more likely to be approved by the FDA than by the EMA. ” wrote the authors.
“The FDA is often accused of being slow to approve oncology drugs. However, critics have not provided specifics, and our study plainly shows that such assertions are unwarranted.”
Two are the reasons indicated by the researchers about this difference in approval timing. The first concerns the submission of the clinical findings by pharmaceutical companies, which usually submit them to FDA prior than to EMA. The second regards the new oncology medicine review time, which takes a lot more time for EMA than for FDA.
This FDA review time shortening over the last two decades is mostly due to the Prescription Drug User Fee Act of 1992. This law gives FDA the authority to collect fees from companies which produce certain drugs and biological products, allowing to use the funds to accelerate approval times and safety and efficacy standards.
“Continued financial support, in the form of user fees and increased appropriations, will be crucial for the agency to keep pace with current scientific discovery – and to maintain and enhance the agency’s critical role of bringing new medicines from the stages of discovery into the clinic and ultimately improving the lives of patients,” the authors concluded the report.
The authors also suggested that the lack of new oncology medicines is due not to slow review processes, but rather to difficulties in carrying out clinical trials in the field of oncology.
“One challenge is the slow acquisition of patients for trials, a phenomenon with many contributing factors—such as patients’ or physicians’ lack of information about trials, patients’ fear of receiving placebo or a poor treatment, the rarity of some cancers, and confounding factors that may make a patient ineligible for a trial. A second challenge is the particularly long times needed to establish a drug’s efficacy, in part because of the slow acquisition of patients and also the need to measure survival over a period of years,” the authors explained.