SLUGGISH FDA APPROVES ONLY 18 NEW DRUGS DURING 2006

Pharmacy Times, Volume 0, 0

The pace of new drug approvalsremained sluggish last year, with only 18"new molecular entities" cleared for USmarketing by the FDA during 2006. Lastyear's total is down from an average of 26new drug approvals recorded during thepast 6 years, and the slowdown hasprompted speculation among pharmaceuticalmanufacturers, regulators, andhealth care professionals.

The number of drug approvals may varyfrom year to year for many reasons, andeven a substantial rise or fall in the approvalrate during any one year may beunrelated to the pace of industry researchor government regulation. Since last year'sslow-footed approval pace came at a timewhen many observers believe that theFDA is growing more cautious in its newdrug review and approval process, however,questions are already being raisedabout whether the government officialsare becoming "risk averse."

For their part, government researchersattributed last year's approval decline tothe fact that the pharmaceutical industryis placing more of its research and development(R & D) emphasis on complexmedicines for difficult-to-treat conditions.

Although the industry is spending morethan ever on new product R & D, the failurerate of drugs in testing has risen, ascompanies target these increasinglyintractable diseases, concluded FDAresearchers.

Others, however, attribute the relativelyslow rate of new drug approvals to thefact that the FDA has been without a permanentfull-time commissioner for muchof the past year.

In December 2006, the Senate finallyconfirmed Andrew von Eschenbach, MD,as FDA commissioner, and someobservers believe his leadership willresult in a higher number of new drugapprovals during 2007.