Federal drug approvals plunge

FDA approvals of new drugs are down 29 percent this year, an industry analyst says.

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NEW YORK (CNNMoney.com) -- Federal drug approvals have plummeted by nearly a third in 2007, according to a report issued Thursday that is likely to fuel complaints that regulators are stymieing efforts to get new treatments on the market.

The Food and Drug Administration approved 59 new drugs through October, down 29 percent from the same period last year, according to a report from James Kumpel, an industry analyst at Friedman, Billings, Ramsey Group.

Significantly, the report says that the problem is not in the industry pipeline.

Kumpel said that the ratio of applications to approvals in 2007 is shaping up to hit a 13-year low. The FDA is on track to approve 60 percent of applications for new drugs this year, compared to 76 percent in 2006.

"While some pundits have argued that the pipeline [of applications] submitted to the FDA by the pharmaceutical industry has been weak in recent years, the facts dispute such claims," said Kumpel, in his report, released on Thursday.

Kumpel found an 18 percent decline in approvals of a key category of drugs - those that are in a brand-new molecular class. The FDA approved only 14 of these new drugs, which represent the most significant medical advances because they do not piggyback onto existing treatments.

In addition, Kumpel's report said approvals of biotech drugs have "fallen off the cliff" to only one new product through October, compared to four in the year-ago period.

But the FDA consistently says it has not toughened its approval process.

"I've been at the FDA for 15 years and we've never changed the standards for drug approval," said Dr. John Jenkins, director of the FDA's Office of New Drugs. "But what happens, sometimes, is that the science evolves, and we have to apply that knowledge to the regulatory process."

Jenkins also said that, according to the FDA's research, "The rate of approval has been fairly parallel to the rate of submission."

But industry analysts charge that the FDA has cracked down on new drug applications in the wake of the Vioxx debacle. The agency came under fire for approving the Merck & Co. Inc. (Charts, Fortune 500) arthritis painkiller, which was withdrawn in 2004 after a study linked it to increased risk of heart attack.

"I am absolutely not surprised that approvals are down, because everybody knows that the FDA has gotten more cautious," said Fran Hawthorne, author of "Inside the FDA."

Hawthorne said the FDA denies that it's gotten tougher, because "they never want to admit they're influenced by anything other than pure science." But after the Vioxx withdrawal, she said the agency is "scared stiff to approve anything with any side effects."

In the post-Vioxx era, FDA's Jenkins said his agency is now requiring long-term studies for cardiovascular risks for that class of drugs, known as non-steroidal anti-inflammatory drugs. But Jenkins interprets this as a change in the available scientific knowledge regarding side effects, not a change in the regulatory process, and that it would be "irresponsible" to ignore it.

Other compounds, aside from Vioxx, have run into a regulatory wall. Novartis' (Charts) diabetes drug Galvus has encountered multiple delays in the review process. In April, the FDA shot down Merck's Arcoxia, an arthritis painkiller that was widely criticized for being a member of the same drug class as Vioxx, despite the fact that it is available in scores of other countries. In June, French drugmaker Sanofi-Aventis (Charts) withdrew its diet drug Rimonabant from the review process after FDA advisers rejected it in a nonbinding vote.

But Dr. Raymond Woosley, chief executive of The Critical Path Institute, a non-profit that assists the FDA with its drug review process, insisted that the agency has not gotten tougher on drug approvals.

The drop in approvals has a lot to do with the quality of drug applications, Woosley said. "We're still testing the drugs the same way we did 40 years ago," he said, noting that the FDA bases its decisions on science, rather than public sentiment. Woosley said that many of the experimental drugs going before the FDA "are often not very innovative, and there are alternatives on the market."

Of course, the industry has had some success in winning the FDA's green light for promising new products.

On Nov. 14 - after the time period of Kumpel's report - the FDA approved the biotech drug Mircera, made by Swiss drug giant Roche. Mircera is an anti-anemia drug for patients with kidney disease.

This year's stock of new drugs also includes the HIV treatments Isentress from Merck and Selzentry from Pfizer Inc. (Charts, Fortune 500) and the breast cancer drug Tykerb from GlaxoSmithKline (Charts).