New drugs to treat and cure sick patients are coming onto the market in the United States at the slowest rate in a decade, despite billions invested by pharmaceutical companies on research and a costly expansion by the federal agency that reviews new medicines.
The decline in the number of new drugs is most pronounced in the category considered by the Food and Drug Administration to have the greatest promise for patients -- those listed as breakthrough "priority" drugs and "new molecular entities" that are different from any others on the market.
The slowdown is troubling to many because it is largely unexpected. The drug industry now invests three times as much money in research as it did a decade ago, and the FDA has undergone a major revamping to become more efficient and prompt -- an expansion funded largely by user fees from the drug makers. Yet the number of industry applications for innovative new drugs is down significantly, and the average time needed by the FDA to review applications is moving up.
The net result of both trends is a steep drop in the number of new drugs coming to the market to help cure and treat illnesses, and growing disappointment among many patients and their families and advocates.
"We hear talk all the time from the drug makers of the great drugs waiting in line, but the reality doesn't seem to match the facts," said Ellen Stovall, director of the Cancer Leadership Council, a patient advocacy group. "There's been a lot of hope about new drug cures and treatments and we've seen some progress, but lots more disappointment."
The possible reasons for the decline -- whether it is a function of FDA caution following some high-profile drug withdrawals, of industry shortcomings and strategies, or of a combination of both -- is the subject of an increasingly urgent debate. Some believe the drop is a relatively short-term development that will resolve on its own, while others believe there is a deeper and more fundamental problem.
"Industry was trying to hit home runs, and it struck out a lot," said Henry McKinnell, CEO of the largest pharmaceutical company, Pfizer Co., in an interview. "Added to that, the (FDA) is giving greater scrutiny to each drug application. The result is that we are spending more time on each drug, spending much more on research, but seeing a definite drop in the number of new drugs."
Like many drug industry leaders, McConnell still sees a "golden period" for new drug discovery ahead. But he acknowledges it might be further off than once predicted.
The newly confirmed commissioner of the FDA, Mark McClellan, has said that getting more drugs into and through the FDA review process is a top priority. McClellan was sworn in Sunday.
The number of new drugs coming onto the market peaked in the mid 1990s, when the FDA approved more than 120 new drug applications in both 1996 and 1997 after being criticized for being too slow. Among the breakthrough drugs approved in that period are the cholesterol-lowerer Lipitor, the novel osteoporosis medication Fosamax, and the protease inhibitors that revolutionized treatment of AIDS.
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