FDA NME and BLA approvals fall to 7 for 1st half 2007, was 11 in same period 2006

The US Food and Drug Administration has approved only seven New Molecular Entities and new Biological License Applications in the first half of 2007, according to Drug Researcher.com, quoting the federal agencies own figures. An eighth was approved, but it had previously been cleared in Europe. This compares with 11 NMEs and BLAs in the same period of last year, and maintains a downward trend observed over the past few years.

A December 2006 report published by the US Government Accountability Office found that the pharmaceutical industry had spent a record $40.0 billion on R&D in that year, while new drug approvals numbered 18, an eight-year low. To some extent, there is a lag between investments and products coming onto the market, however, many analysts and drug industry observers would probably agree with Michael Rosenberg, president of Health Decisions, a USA-UK-based clinical research organization, there that there has been a "productivity meltdown of historic proportions."

Three NMEs, one BLA approved in 1st qtr