FDA drug approvals mostly flat in 2009 as new leadership takes reins at agency

more images

more images

more images

more images

more images

more images

FDA drug approvals mostly flat in 2009

WASHINGTON — New drugs cleared by the Food and Drug Administration last year kept pace with 2008, suggesting a much-touted push for drug safety has not slowed down approvals.

The FDA’s new leaders did step up early warnings about potential drug safety issues and citations to companies that violate safety regulations.

Drug approvals inched higher to 26 first-of-a-kind prescription medicines last year, from 25 in 2008, according to figures from Washington Analysis, an investment research group. New drugs cleared in 2009 included Novartis’ kidney cancer drug Afinitor and Bausch and Lomb’s pink eye medicine Besivance.

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.

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.

In August, Hamburg announced the agency would speed up and expand its issuance of warning letters to companies that don’t follow FDA regulations.

“The agency must show industry and consumers that we are on the job,” Hamburg said. “Companies must have a realistic expectation that if they are crossing the line, they will be caught.”

Analysts say the take-charge attitude has energized the staff and empowered them to make decisions.

“Sharfstein and Hamburg bring confidence and certainty to an agency that was badly in need of it,” said Ira Loss, an analyst with Washington Analysis who has covered the agency for three decades. “The rank-and-file staffers are now able to move with confidence that the agency has their back.”

In the past year, the FDA also increased its use of so-called early communications, a sign the agency is acting more quickly to address safety concerns. Under the policy, the 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.

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

Since last spring, FDA regulators moved to shut down makers of phony swine flu remedies, defective nasal sprays and dietary supplements that contain steroids.

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.

The agency says it has addressed staffing issues that slowed reviews in recent years, and is operating within its goal of taking 10 months to review regular drug applications and six months for priority applications.