Tuesday, May 10, 2011

FDA biopharmaceutical drug approvals increase despite slower development time

By Michelle Lang

The U.S. Food and Drug Administration has passed nearly twice as many biopharmaceutical drug approvals in the last 10 years than it did in the 1990s, a news release from the Tufts Center for the Study of Drug Development (CSDD) has indicated.

From 2000 to 2009, 65 biopharmaceutical drugs got the OK from the FDA. In comparison, the 1990s saw 39 approvals, while the 1980s had 13 approvals, according to the CSDD study.

The numbers offer a counterpoint to the increasing average timeframe between the first clinical study to regulatory approval, which has bumped from 77 months for biopharmaceutical firms in the 1990s to an average of 95 months in the last decade. The average development period from 2000 to 2009 was not affected by orphan status nor fast track designation for biopharmaceutical drugs.

The CSDD study did show that the last decade offered up a more evenly distributed approval rate of biopharmaceutical drugs in six therapeutic categories, compared to the previous two decades.

In March, Tufts CSDD published its Impact Report, which showed that more drugmakers are getting their already approved drugs passed by the U.S. Food and Drug Administration for other indications.