FEBRUARY 01, 2007

The pace of new drug approvals remained sluggish last year, with only 18 "new molecular entities" cleared for US marketing by the FDA during 2006. Last year's total is down from an average of 26 new drug approvals recorded during the past 6 years, and the slowdown has prompted speculation among pharmaceutical manufacturers, regulators, and health care professionals.

The number of drug approvals may vary from year to year for many reasons, and even a substantial rise or fall in the approval rate during any one year may be unrelated to the pace of industry research or government regulation. Since last year's slow-footed approval pace came at a time when many observers believe that the FDA is growing more cautious in its new drug review and approval process, however, questions are already being raised about whether the government officials are becoming "risk averse."

For their part, government researchers attributed last year's approval decline to the fact that the pharmaceutical industry is placing more of its research and development (R & D) emphasis on complex medicines for difficult-to-treat conditions.

Although the industry is spending more than ever on new product R & D, the failure rate of drugs in testing has risen, as companies target these increasingly intractable diseases, concluded FDA researchers.

Others, however, attribute the relatively slow rate of new drug approvals to the fact that the FDA has been without a permanent full-time commissioner for much of the past year.

In December 2006, the Senate finally confirmed Andrew von Eschenbach, MD, as FDA commissioner, and some observers believe his leadership will result in a higher number of new drug approvals during 2007.