FDA Drug Approval

The FDA hasn’t yet tallied its year-end drug approvals but will have the number by Friday. As of Dec. 1 the agency reported 25 new drugs approved.  In 2008 it approved 25 new drugs, that number is likely to go up by one when the final tally is taken.
During 2009, the agency added 31 new or updated “black box” warning labels to drugs already on the market. That was down from 56 boxed warnings in the previous year, when the agency issued several broad warnings that resulted in boxed labels for entire groups of drugs.

The 2009 totals suggest a moderate approach to regulation from FDA, despite drug industry concerns that recently-appointed Obama administration officials would result in fewer drug approvals.

President Barack Obama tapped Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein last year to restore the agency’s credibility, following a string of safety problems involving everything from blood thinners to peppers to peanut butter.

FDA issues warnings to the public when it first begins looking at potential side effects with a drug, even if no direct link has been established.  The agency issued five early communications last year, including reports of liver damage with GlaxoSmithKline PLC’s over-the-counter weight loss pill alli and heart problems with Roche’s asthma drug Xolair. Both issues are still under investigation. In 2008 the agency issued two early communications. Since last spring, FDA regulators moved to shut down makers of phony swine flu remedies, defective nasal sprays and dietary supplements that contain steroids.

FDA also stepped up actions against bogus or dangerous consumer products. 

Drug industry executives have criticized the FDA in recent years for approving fewer new drugs. Drug approvals peaked at 53 in 1996 and have bounced around in the twenties and teens in recent years. Many critics suggest the agency has become too cautious in response to the safety scandal surrounding Vioxx, the Merck painkiller which FDA approved in 1999 but then pulled from the market in 2004 due to heart risks.

FDA officials have countered that new drug submissions have been declining for a decade as companies struggle to come up with new medications. The FDA can’t approve drugs that aren’t submitted.

New drugs cleared in 2009 included Novartis’ kidney cancer drug Afinitor and Bausch and Lomb’s pink eye medicine Besivance.

Currently FDA is operating within its goal of taking 10 months to review regular drug applications and six months for priority applications.