Editor's Corner

The decision by the FDA's expert panel to back an inhaled insulin product from Pfizer (below) underscores a big new trend in the drug development business. In order to calm fears about the long-term effects of the new drug, Pfizer is offering to develop an aggressive program for tracking users to identify any safety issues that may come up. Just a day earlier we saw another biotech, Bristol-Myers Squibb, make the same promise for its RA drug orencia. In the post-Vioxx world, drug companies that hope to push major new drugs into the marketplace will need to have fully developed pharmacovigilance programs in place, ready to identify complications as they arise. It will be a critical mission of the drug companies to make sure that they do what's promised, as any new crack in the industry's credibility will have a potentially devastating impact on biotech's ability to gain approval for new products. Too many drug companies have clearly put profits ahead of safety in recent years. Now, though, drug developers will have the added incentive of knowing that any gaming of their pharmacovigilance programs can only result in a massive liability issue. - John Carroll