New drug approvals still down

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Only 21 drugs were approved by the FDA in 2010. In 2009 and 2008, there were 25 and 24 drugs approved respectively, while 2007 marked an all-time low with only 18 new drugs approved.

What are the reasons behind the decline in new drug approvals? ACSH’s Dr. Elizabeth Whelan believes that “excessively stringent safety standards at the FDA” are to blame.

Among the most noted rejections last year were two weight-loss drugs, Vivus Inc.’s Qnexa and Arena Pharmaceuticals Inc.’s Lorcaserin. In addition, Abbott Laboratories’ weight-loss drug Meridia was removed from the market in October. GlaxoSmithKline’s diabetes drug Avandia was placed under tough restrictions in September, while last month, the FDA said it will be working to remove the breast cancer indication for Roche’s biotech drug Avastin.

ACSH’s Dr. Josh Bloom adds that substantial cuts in pharmaceutical research staff over the past decade have exacerbated the problem. “In addition, the kinds of diseases we’re tackling now are more difficult than those from decades earlier. Cancer and Alzheimer’s disease are current targets that are more complex to treat, especially with fewer scientists working in research and development.”

But this doesn’t mean that we can’t improve upon treatments that we already have, says ACSH’s Dr. Gilbert Ross. “For example, even though statins are used to treat high cholesterol, the market could still use a drug that can safely raise good HDL cholesterol levels and reduce the mortality from heart disease. This is just one example of an area ripe for further investigation.”

Dr. Ross also blames the FDA’s focus on risk aversion and its habit of downplaying the benefits of new drugs for the recent fall-off in drug approvals. “As one of our advisors Dr. Henry Miller points out, when the FDA prevents a drug from getting to the market, no one hears about the thousands of people that could have benefited tremendously from it. Unfortunately, the media will incessantly remind us about the side effects that might arise if a drug does get approved.”

“It is a combination of the FDA’s conservative approach, more complicated research targets and fewer scientists that has created this perfect storm of the dearth of approved drugs we now face,” says Dr. Bloom, as he notes that not a single antibiotic was included among the few drugs that were approved last year despite the looming threat of multi-drug resistant microbes.