Approval for Cancer Drugs Faster in US than in Europe — Finds A Study

Cancer is a deadly disease caused by the uncontrolled growth of abnormal cells in the body. Anticancer drugs are vital in controlling the growth of cancerous cells.

Given the lethal nature of cancer, it is worthwhile to note that a new cancer drug gets approved by FDA (U.S. Food and Drug Administration) in the United States in about six months, whereas in Europe it takes almost a year for the same to get approved by EMA (European Medicines Agency)—according to the study published online in the journal Health Affairs, a leading health policy journal.

The above study looked at the new cancer drugs that were approved by the FDA and the EMA between 2003 and 2010. Out of a total of 35 cancer drug applications filed with FDA during that period, it was noted that 32 of these novel drugs were approved in an average of 182 days; only for 3 drugs, it took more than a year for approval. On the other hand, the EMA took an average of 350 days, almost a year, to approve 26 drugs; also, nine drugs were not approved.

A study by Friends of Cancer Research group also found that FDA approved novel cancer medicines at a faster pace than that of its European counterpart, EMA. Thus, all of the anticancer drugs, which were approved by both agencies FDA and EMA, were first available to the US patients before they were available to the European patients.

These findings show that FDA had followed a faster review procedure compared with EMA that had followed a long, bureaucratic process in the approval of anticancer drugs. Moreover, FDA’s greater speed in new cancer drug approvals is credited to the financial support received by it through the user fees collected from the drug industries towards the review of their new drugs, which is due to the result of Prescription Drug User Fee Act (PDUFA).

Early detection and treatment help in the longevity and improved survival of a cancer patient. A fast-track drug review process by the EMA in approving new cancer drug applications across the European Union will provide access to the new drugs to all its EU citizens suffering from cancer as at the same time in the US. Thus, the speeding up of the drug approval process will help enable a new drug to pass from the stages of discovery into the clinics, which is an incredibly important factor in improving the lives of cancer patients.

June 23, 2011