The FDA approved 19 new drugs last year, the fewest in 24 years. The number of new meds, including those made with novel chemical ingredients and using biotechnology, was three less than in 2006, Bloomberg News reports. Last year’s approvals were tallied by analyst Ira Loss, but the FDA declined to confirm the numbers.

Drugmakers complain the FDA raised standards for approvals in the wake of safety concerns, an assertion the agency denies. But pharma shifted its emphasis to tinkering with existing drugs and finding other diseases these could be used to treat, instead of developing new meds, says Ken Kaitin, director of the Tufts University Center for the Study of Drug Development.

“They got away from their core mission, which was to bring new medicines and new treatments to market,” Kaitin tells Bloomberg. “If you’re putting money into extending the lifecycle of a drug on the market, you’re taking money away from a drug development program.” But he adds that drugmakers are returning to developing new treatments and the annual approval numbers should increase in coming years.

The FDA’s Web site lists 14 new molecular entities approved through November of last year. Three more were approved in December, bringing the total to 17, according to Loss, who tracks the FDA for Washington Analysis in Washington, DC. In addition, the agency cleared two new treatments last year that use biotechnology, gene-based products derived from living organisms, Loss tells Bloomberg.

The combined total of approvals is the lowest since 1983, according to the Tufts drug development center. In that year, there were 14 new drugs approved, none of them biotech products. The FDA hasn’t tallied the approvals for last year and couldn’t confirm the number, agency spokesman Chris DiFrancesco tells Bloomberg, adding that he isn’t sure when the agency’s annual data on new drug applications and approvals would be ready.

Novartis and Glaxo each had two new drugs approved in 2007, the most of any companies.

The FDA hasn’t changed its approval standards, said Janet Woodcock, the agency’s deputy commish, wrote to Bloomberg in an e-mail. The number of marketing applications for novel drugs has declined in recent years, and the agency is better able to detect risks. “Our standards for what constitutes a safe, effective drug have not changed,” Woodcock wrote. “But our ability to analyze data for potential safety problems has improved, and we’re especially vigilant when we’re evaluating drugs for chronic conditions - drugs that people will be taking daily for many years.”

Several drugmakers experienced delays last year, Bloomberg notes. Sanofi pulled the application for its obesity pill Zimulti after an FDA advisory panel raised questions about risks of suicidal thoughts and depression. Novartis’s painkiller Prexige was rejected by the agency. Wyeth had three products, including Viviant, a treatment for preventing bone loss.

“FDA leadership has been open, both in conversations with us and in statements made publicly, about the changing climate, and the fact is that approvals are down,” Bob Ruffolo, Wyeth’s R&D chief, wrote Bloomberg. “It’s our job as innovators to determine the best way to be successful in this new environment.”

Not all drugmakers blame the FDA. “Most of the answers” for the decline in drug approvals are “internal” to pharma says, Martin Mackay, Pfizer’s recently promoted R&D chief, tells Bloomberg.

Companies are increasingly developing drugs to treat the cause of diseases rather than common symptoms that were easier to target, says Raymond Woosley, president of the Critical Path Institute in Tucson, Arizona, which is working with the FDA on revamping the drug approval process. “If you go after the basic cause of the disease, it’s just much more complex” and many such drugs fail during human testing, Woosley tells Bloomberg. “A lot of these don’t get to the FDA.”

Source: Bloomberg News