Federal Regulators Increase Scrutiny of Rx Drugs

FDA in recent months has rejected a "slew" of new drug applications or delayed approval of experimental medications and required more data, as the agency faces increasing concern over drug safety since the painkiller Vioxx was pulled from the market in 2004, the AP/Baltimore Sun reports.

FDA this year has approved 61% of new drug applications through mid-August, compared with 73% during the same period last year. The AP/Sun reports that the increased rejections have affected patients' access to new medications, hurt drug manufacturers stock prices and are expected to increase the time and cost of developing new and future medications.

Steve Brozak, an analyst with WBB Securities, said, "The FDA is being more cautious" because it realizes that new medications will be used off-label, which can increase the risk of serious side effects. Brozak said the agency's mentality now is that it has "got to be so safe that we're not going to be criticized ever" for approving the drug.

James Kumpel of Friedman, Billings, Ramsey recently published a report showing that FDA approval of medications made from new chemical compounds were at their lowest rates in at least the past 10 years, according to the AP/Sun.

FDA approved seven "new molecular entities" through the end of July, compared with an average of 12 over the first seven months of every year since 1998, the report shows.

Kumpel said that "FDA certainly has made it more difficult for pharmaceutical companies by pushing for more participants and for longer studies," adding that stricter requirements for approval will start to limit the number of new blockbuster drugs.

However, FDA spokesperson Christopher Kelly said, "There have been no systematic changes in how we are approaching the approval standards for new applications," adding, "Whether the current public debate and criticism of FDA on drug safety has played any role in our actions is very hard to 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 and now is requiring that experimental drugs similar to treatments already on the market show increased safety and efficacy over existing medications (AP/Baltimore Sun, 8/18).