FDA: Henney Says Approval Process is Solid

      FDA Commissioner Dr. Jane Henney yesterday disclosed an internal review that found that the agency's expedited review process was not to blame for the recent spate of drug recalls. She said, "Adverse events are no greater now than when the system was slow." Overall approval time for new drugs has dropped from 30 months to 12, and the agency has increased the number of drugs it approves annually from 70 to 97, the New York Times reports. The study also found that "serious reactions to new drugs were occurring less frequently than in the past," and noted that two of the five drugs withdrawn in the past year were approved before the new law. The study found that historically the FDA has withdrawn 1% to 3.5% of drugs it approves.

Communication, Communication
      The report, which Henney commissioned when she took over the FDA six months ago, looked at both the "risks posed by products the FDA approves" and how the health care system handles these risks. It concluded that the "[g]overnment and private industry must work together to develop a 'new framework' for reducing risk that will draw doctors, hospitals, pharmacists and patients into a dialogue about drug safety." A second study on the Prescription Drug User Fee Act will appear this week in the Journal of the American Medical Association (Stolberg, 5/11). The Wall Street Journal reports that industry and health care groups will meet in the fall (5/11).

Cut the Red Tape
      In an op-ed in the Charlotte Observer titled "Drug bureaucracy lives," former FDA official Dr. Henry Miller writes that the "time required for the final review" of a drug "is not an accurate reflection of the stringency and control imposed by the FDA on drug testing. In fact, intrusiveness, strictness and length of the FDA's regulation of drugs have been increasing, not decreasing." He cites a Tufts University study that found while final review times have decreased, "the time from the synthesis of a new drug to its marketing approval increased from 14.1 years between 1980 and 1989 to 15.2 years between 1990 and 1996." He says that higher regulatory hurdles have forced drug companies to concentrate on blockbuster drugs, "while drugs for lifesaving but narrower uses are neglected. Huge drug companies merge in order to achieve even greater economies of scale." He concludes: "These trends should be cause for alarm. Fewer drugs will be developed and those that do emerge from the pipeline will have inflated prices" (Miller, 5/11).