FDA Rejects More New Medications This Year Than In 2006

FDA in recent monthshas rejected a "slew" of new drug applications or delayed approval ofexperimental medications and required more data, as the agency facesincreasing concern over drug safety since the painkiller Vioxx waspulled from the market in 2004, the AP/Baltimore Sunreports. FDA this year has approved 61% of new drug applicationsthrough mid-August, compared with 73% during the same period last year.

The AP/Sun reports that the increased rejectionshave affected patients' access to new medications, hurt drugmanufacturers stock prices and are expected to increase the time andcost of developing new and future medications. Steve Brozak, an analystwith WBB Securities,said, "The FDA is being more cautious" because it realizes that newmedications will be used off-label, which can increase the risk ofserious side effects. Brozak said the agency's mentality now is that ithas "got to be so safe that we're not going to be criticized ever" forapproving the drug.

James Kumpel of Friedman, Billings, Ramseyrecently published a report showing that FDA approval of medicationsmade from new chemical compounds were at their lowest rates in at leastthe past 10 years, according to the AP/Sun. FDA approvedseven "new molecular entities" through the end of July, compared withan average of 12 over the first seven months of every year since 1998,the report shows. Kumpel said that "FDA certainly has made it moredifficult for pharmaceutical companies by pushing for more participantsand for longer studies," adding that stricter requirements for approvalwill start to limit the number of new blockbuster drugs.

However,FDA spokesperson Christopher Kelly said, "There have been no systematicchanges in how we are approaching the approval standards for newapplications," adding, "Whether the current public debate and criticismof FDA on drug safety has played any role in our actions is very hardto quantify." Chris Milne, associate director of the Tufts Center for the Study of Drug Development,said FDA has implemented more controls for examining drug safety andnow is requiring that experimental drugs similar to treatments alreadyon the market show increased safety and efficacy over existingmedications (AP/Baltimore Sun, 8/18).

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