Most New Drugs Approved Worldwide Were First Marketed in the US

ePT--the Electronic Newsletter of Pharmaceutical Technology

Although the number of annual new-drug approvals in the United States has steadily declined during the past ten years, pharmaceutical companies still prefer to introduce new products in the US first, according to a report published by the Tufts Center for the Study of Drug Development.

Boston (Nov. 12)-Although the number of annual new drug approvals in the United States has steadily declined during the past 10 years, pharmaceutical companies still prefer to introduce new products in the US first, according to a report published by the Tufts Center for the Study of Drug Development (CSDD).

The report says new US drug approvals fell to 48 between 2005 and 2007. The highest number was between 1996 and 1998, when 110 new US drugs were approved.

Yet during 2005–2007, 75% of all new drugs approved worldwide were first marketed in the US. CSDD notes that this percentage is an all time high and a marked change from the 1987–1989 period, when only 20% of new drugs were first marketed in the US.

“The United States has become the country of choice to introduce new prescription drugs to the market due, in large part, to the size of the pharmaceutical market, the positive environment for innovation, and the lack of price controls,” says Kenneth I. Kaitin, director of Tufts CSDD, in a press release. “For example, because many countries limit the prices that drug companies can charge for their products, they turn to the US.”

Kaitin adds that the decline in new drug approvals reflects the increasing amount of time, risk, and expense associated with drug development.

The report also includes the following findings:

  • Combined clinical and approval times for new drugs developed in the US have fallen to the lowest level since the late 1990s.

  • Since the enactment of Prescription Drug User-Fee Act of 1992, average approval times have declined and reached their lowest three-year average (1.1 years) between 2005 and 2007.

  • Clinical times for priority and standard drugs spiked between 2002 and 2004, but between 2005 and 2007 the numbers returned to levels similar to those observed between 1996 and 1998 as well as between 1999 and 2001.

  • The average total time from investigational-new-drug filing to new-drug-application approval for medicines approved between 2005 and 2007 was the longest for endocrine drugs (8.9 years) and the shortest for antineoplastic drugs (6.1 years).