FDA DRUG APPROVALS SLUGGISH IN 2007

The FDA got off to a slow start with new drug application (NDA) approvals in 2007, approving barely more than half as many as it had by this time last year.

The agency approved four NDAs in January and five in February, down from 16 in the first two months of 2006. Further, the FDA has approved only one new molecular entity, down from four in January and February of last year. However, the approval rates were consistent with the agency's average for the first two months of each year between 2002 and 2005.

The FDA is likely to implement a stricter review process after criticism from the Institute of Medicine (IOM) spurred the agency to promote its drug safety efforts, analysts from Friedman Billings Ramsey (FBR) said. Following the IOM's report, the FDA issued a series of recommendations emphasizing the need for greater transparency and an increased focus on safety in the drug review process.

Despite the more rigorous review process, the rate of overall drug approvals should increase over the next few years, according to FBR.

Other companies, such as contract research organizations, will benefit from the FDA's increased drug safety monitoring, FBR said. Congress will likely attach mandatory postapproval monitoring provisions to the Prescription Drug User Fee Act when the bill comes up for reauthorization later this year, the firm added. Contract research organizations are also likely to partner with developers of electronic data capture systems as they become more popular, FBR said.