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 But these twin challenges
-- evidence that the heyday of blockbuster drug-development is over -- are forcing the industry to ponder big changes in the laboratory. The biggest, analysts say, is likely to be a shift toward finding treatments for patients with rare diseases, or unusual strains of common afflictions.
By focusing on boutique medications, analysts say, drug makers will arouse less scrutiny from regulators, who have become extra sensitive to the potentially fatal side effects of widely prescribed medications for ailments such as arthritis and diabetes. The growing need to market niche treatments is also dictated by the reality of the business, in that there are fewer widespread maladies for which a popular pill doesn't already exist.
A lot is riding on the industry's ability to navigate this transition. For years, drug makers such as Pfizer Inc. and Merck & Co. could count on new blockbuster drugs to deliver double-digit profit growth. In the last two years, however, patents expired on Pfizer's blood pressure treatment Norvasc, Merck's cholesterol drug Zocor and more than $40 billion worth of other drugs. Meantime, the Food and Drug Administration delayed or denied would-be blockbuster therapies made by Sanofi-Aventis SA, Wyeth and others.
With profit growth slowing across the pharmaceutical industry, Pfizer and GlaxoSmithKline PLC
-- the world's first- and second-largest drug makers -- each announced plans in 2007 to lay off thousands of employees.
"The hurdle has been raised, there's no question about it," GlaxoSmithKline Chief Executive Jean-Pierre Garnier said during a conference call to discuss third-quarter earnings. "What is unclear is exactly how we should modify our drug development plans to meet this higher hurdle."
Garnier and other executives say the FDA has become an increasingly cautious gatekeeper for new drugs, especially those to treat widespread ailments that aren't necessarily life-threatening. And the regulatory environment will only get tougher in 2008, when new rules kick in that allow FDA to limit how widely drugs are promoted and distributed to patients and physicians.
Drug companies griping about an overbearing FDA is a familiar refrain, but data backs up their contention that the agency is quicker to issue warning labels.
The FDA announced nearly 70 new or updated black box warnings on previously approved drugs in 2007, more than twice as many as in 2004, according to government data compiled by Joyce Generali, director of the Drug Information Center at Kansas University Medical Center. The warnings are the most serious a drug can carry.
In the past year, the agency also balked at approving Sanofi-Aventis' highly anticipated obesity drug Zimulti and sent Novartis AG and Wyeth back to the lab for more safety studies on their treatments for diabetes and menopause. The FDA also flatly rejected Merck's arthritis drug Arcoxia, a follow-up to Vioxx, the best-selling pain medication pulled from the market in 2004 after links to heart attack and stroke were found.
The withdrawal of Vioxx triggered a flurry of congressional hearings, during which the agency's ability to resolve drug-safety problems came under fire.
Former FDA Commissioner Mark McClellan, who left the post in early 2004, said the pressure to hold drugs to a higher standard of safety has increased dramatically since Vioxx.
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 FDA staff reject the bar-raising theory, pointing out that the percentage of drugs approved to those submitted has held steady in recent years.
But the agency has approved just 16 first-of-a-kind drug applications this year, a 20-year low that is 36 percent below the annual average over the last decade. FDA approved 18 first-of-a-kind drugs in 2005 and 2006, down from 31 in 2004.
Those who track pharmaceutical trends say companies share responsibility for the new-drug drought.
The number of applications for innovative drugs submitted to FDA has steadily declined since the mid 1990s, falling from a high point of nearly 60 submissions in 1995 to figures in the low 20s for recent years.
Operating under a "just say no to risk," mantra, companies have chosen to tweak drugs already on the market rather than invest in the unknown, said Steve Brozak, an analyst with WBB Securities.
"No pharmaceutical executive has ever lost his job for saying no to a new drug project," Brozak said. "And no FDA employee has ever lost his job for saying no to a new drug application."
Most recent biopharmaceutical breakthroughs have been for drugs to treat smaller patient groups.
Biotech powerhouse Genentech Inc. has successfully developed cancer treatments tailored to patients' specific genetic makeup. Meanwhile, Cambridge, Mass-based Genzyme Corp. has built a multibillion-dollar business around expensive treatments for rare diseases.
Several major pharmaceutical companies are already spending more on innovative biotechnology.
In the last year, Roche Holding Ltd. and Merck separately agreed to pay $1 billion for the rights to research drugs designed to silence genes that trigger certain diseases. The companies are banking on the research yielding personalized medicines with fewer side effects.
Investment in experimental technology, however, isn't as widespread a reaction as Wall Street expected.
Biotech drug maker Biogen Idec Inc. surprised investors earlier this month, saying it could not find a buyer two months after putting itself up for sale. Analysts had speculated that Pfizer, GlaxoSmithKline and Novartis AG might be interested in the company.
There are some industry observers who, counterintuitively, believe the FDA will become more willing to approve experimental drugs when the new regulations go into effect because they will be able to react with greater force when safety issues arise.
But most see that as wishful thinking.
"The pendulum at FDA is going to be stuck at the conservative end," said Christopher Milne, of the Tufts Center for the Study of Drug Development. Eventually, Milne believes, drug companies will learn to deal with a more cautious FDA, but only because they won't have any other choice.
[Associated Press; By MATTHEW PERRONE]
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