updated 12/19/2008 4:02:23 PM ET 2008-12-19T21:02:23

The number of new drugs approved by the Food and Drug Administration has ticked upward in 2008, even as regulators failed to meet review deadlines on more than a dozen drugs.

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The FDA will approve at least 21 first-of-a-kind drugs this year, up from 18 in 2007. At the same time, analysts say the agency missed its target review dates for at least 15 drugs.

In recent years the drug industry has criticized the FDA for approving fewer new drugs. Many critics suggest the agency has become too cautious in response to deadly side effects of drugs such as Vioxx, the Merck painkiller pulled from the market in 2004.

FDA officials point out that new drug submissions have been declining for almost a decade as companies struggle to come up with new medications. The FDA can't approve drugs it doesn't receive, they argue.

But that hasn't appeased drugmakers and their investors, who say that even when FDA meets its review goals, it increasingly sends companies back to the lab for more testing. This year regulators delayed decisions on a range of drugs, including Johnson & Johnson's psoriasis drug ustekinumab, and Eli Lilly's blood thinner prasugrel, a potential blockbuster product.

Executives acknowledge that part of the reason for the delays is the increasingly sophisticated nature of the drug review process.

"The conversations are tougher than they were 20 years ago because the issues are tougher," Pfizer Vice President Robert Clark said at a recent industry conference. "Twenty years ago I guaranteed that I would get a new drug application approved, and that's not exactly what I'm saying today."

Mixed picture
While it's almost impossible to assess FDA's drug review performance from the still-incomplete 2008 data, the latest figures paint a mixed picture.

Industry executives are likely to focus on the unusually large number of missed deadlines. On average, drugmakers spend about 15 years developing a new drug, and each month an application sits at FDA represents lost revenue.

Since the early 1990s, the FDA has tried to review applications on strict timelines, in return for company payments that fund the hiring of more scientists. For 2008 the agency is supposed to review 90 percent of drug applications on time. While final data for 2008 are not yet available, FDA officials say they do not expect to reach that goal.

Earlier this year FDA's chief drug reviewer gave staff permission to begin missing review dates, citing personnel shortages and other challenges.

Excluding the recent dip in performance though, the FDA states that review times have not changed significantly, according to data presented at a recent conference.

"In my sixteen and a half years at FDA, I have never received or issued an order to speed up or slow down," said John Jenkins, director of FDA's Office of New Drugs. "We review each application on its merits and apply our best judgment with regard to the data, science and regulations."

Recent examples of missed review goals include Amgen's novel blood-thickening drug Nplate, approved a month after its target date. Meanwhile, Astellas Pharmaceutical's heart rhythm drug vernakalant received a request for more safety data in August, more than half a year after its target date. The company is still waiting for a decision.

‘Fairly quiet year’
As analysts comb through data from the past year, there are indications that regulators have been less draconian than critics suggest.

The most recent data available show that FDA placed 46 new or updated black box warning labels on previously approved drugs in the first three quarters. That's 25 percent fewer than the 62 announced in the same period last year. The boxed warnings are the most serious a drug can carry.

"I would characterize 2008 as a fairly quiet year on the safety side," said Murray Aitken, senior vice president with research firm IMS Health.

Looking ahead to 2009, analysts see plenty of challenges for the drug industry. President-elect Obama has pledged to lower health care costs by using government leverage to push for lower drug prices. And Democrats on Capitol Hill are considering a slew of proposals hostile to the sector, including restrictions on drug advertising.

But former FDA staffers challenge the idea that a Democratic administration means a more risk-averse agency.

"I don't see any evidence that scientists are wringing their hands and saying, 'We need to react to this new president coming in and be more cautious,'" said William Hubbard, a former FDA associate commissioner who spent more than 30 years at the agency.

For the past two years, the Republican-led FDA has been subject to a flurry of investigations by Democrats in Congress. Current FDA Commissioner Andrew von Eschenbach was called before lawmakers to answer for tainted pet food, contaminated blood thinners and other problems. Von Eschenbach plans to step down Jan. 20, the day of Obama's inauguration.

Hubbard and others say a Democrat-controlled Washington may carry a silver lining for drugmakers: With both the FDA and Congress controlled by the same party next year, some observers think the agency will get less scrutiny from politicians.

"Personally, I'm much more optimistic in terms of what the FDA may look like a year or two from now in terms of industry's ability to get products through," said Patrick Ronan, a former FDA chief of staff who now runs a food and drug consulting business.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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