Drug approvals down, drug warnings up

WASHINGTON The pharmaceutical industry is headed down a rough road as drug approvals become harder to grasp and pipelines start to disappear, according to the Associated Press. As a result, drug companies, according to analysts, will move toward finding treatments for patients with rare diseases.

By doing this, drug makers won’t stand out as much to the Food and Drug Administration, which has become very sensitive to the side effects of widely prescribed medications for ailments. Companies are desperate to find relief from all the money they’re losing to generic introductions of their blockbuster drugs.

With profit growth slowing across the pharmaceutical industry, Pfizer and GlaxoSmithKline, the world’s first- and second-largest drug makers, each announced plans in 2007 to lay off thousands of employees.

The companies do have a reason to worry; in 2007, the FDA announced 69 black box warnings on approved drugs, more than twice as many as in 2004, according to the Kansas University Medical Center. In addition, the FDA has approved only 16 drug applications this year, the lowest amount in 20 years, but this also falls on the companies’ shoulders, as they haven’t been submitting as many applications for new drugs as they used to. The submission rate for new drugs has gone down from nearly 60 in 1995 to figures in the low 20s for recent years.

The upshot of all this is that drug companies will still have to conform to the regulations of the FDA, because they won’t have any other choice.