FDA Approval Process Slowing

The recent lengthy review of a novel antipsychotic medication may be indicative of a trend at the U. S. Food and Drug Administration (FDA). A review of FDA files shows that the agency took almost 40 percent more time to approve new drugs during 2000 than it did the previous year. This is in stark contrast to the previous seven-year run of increasingly faster approval times.

Indeed, the apparent slowdown by federal regulators charged with approving new medications for sale has some players in the pharmaceutical industry a little concerned. However, the longer approval process may be indicative of increased scrutiny in reaction to several new drugs having been pulled from the market in recent years after patients developed unexpected and often serious side effects.

Last year the FDA approved 27 medicines that contained active ingredients never before sold in the U.S., a highly watched category of drugs the FDA calls “new molecular entities” or “NMEs.” Included in this category was the new antipsychotic ziprasidone, which received its “approvable letter” last fall, and gained final marketing clearance last month.

During 1999 the FDA approved 35 NMEs, taking an average of 12.6 months to review the approval applications. In contrast, during 2000 the 27 NMEs approved took an average of 17.6 months. Some medications, however, were approved in record short reviews of six months or fewer, including Abbot’s Kaletra to treat HIV and Pharmacia’s antibiotic Zyvox. Others took longer than 18 months, including Pfizer’s ziprasidone and Novartis AG’s Exelon for Alzheimer’s disease.

According to Alan Goldhammer, an industry analyst at the Pharmaceutical Research and Manufacturers of America (PhRMA), the slowdown was a surprise, and PhRMA is trying to determine the reasons for the change. Goldhammer suspects that approvals are slowing as FDA reviewers increasingly seek additional clinical data to document the safety and efficacy of a new product, as was the case with ziprasidone.

Although the safety of patients may be a driving concern for the slowdown, Goldhammer said that industry executives are wary, citing concerns that the slowdown results not only in delays of availability of new drugs for consumers, but also, of course, delays in revenues for the drug companies.