Regulatory Focus™ > News Articles > Study: FDA Beats EU Counterparts in Approving Oncology Drugs, but Otherwise Slower

Study: FDA Beats EU Counterparts in Approving Oncology Drugs, but Otherwise Slower

Posted 06 September 2012 | By

A new report just published by the Tufts Center for the Study of Drug Development (CSDD) has found that the US Food and Drug Administration (FDA) is faster than its EU counterpart in approving oncology products, but slower to approve non-oncology products.

The study, published 5 September, looked at approval times for oncology products relative to non-oncology products in both the US and EU.

Tufts said its research found that in the US, oncology products received approval more than 10 months faster than non-oncology products on average-something borne out by an earlier study released in May 2012 by the California Health Institute (CHI) and the Boston Consulting Group (BCG).

Similarities to Earlier Reports

The CHI/BCG report found oncology products took an average of 11 months to approve, representing one of the lowest average approval times of any category. On the high end of the spectrum were central nervous system (CNS) and gastrointestinal (GI) drugs, both of which took approximately 22 months to approve on average.

Tufts researchers said they found the same thing. "For drugs approved by FDA from 2002 through 2011, approval times were 10 months shorter for oncology vs. non-oncology drugs," the group wrote in a press release.

European regulators, meanwhile, led by the European Medicines Agency (EMA), approved non-oncology drugs nearly two months faster than oncology drugs. "Approval times for non-oncology drugs in the EU were 27% shorter than similar approvals in the US, but 54% longer for oncology therapeutics," CSDD explained.

The latter point potentially clashes with an earlier study published in the New England Journal of Medicine (NEJM), which found FDA's drug approval averages to be faster than EMA's during the 2001-2010 time period. During that time, FDA approved 225 new drugs, with each product taking an average of 303 days to approve. EMA meanwhile approved 186 drugs, and took an average of 366 days to approve them.

Encouraging Trends Emerge

Several encouraging nuggets of information were also gleaned from the study, wrote Christopher-Paul Milne, director of research at CSDD. "What's encouraging is that while total development time for oncology and non-oncology drugs decreased by half a year during the 2002-11 period, for oncology drugs this was accomplished by process improvements that shortened regulatory review time."

In addition, the total development time between the start of development and the approval of a drug dropped 20% between the 2002-06 and 2007-11 periods, going from an average of 8.3 years to 6.6 years.

Both the US and EU also improved the proportion of orphan oncology products being approved. Between 2007 and 2011, 39% of oncology products approved by FDA were for orphan conditions-so named because they affect small populations of individuals, usually fewer than 200,000-while 37% of oncology products approved in the EU were. Those numbers were up from 31% and 28%, respectively.

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