The FDA is stepping up their regulatory game

In late September the FDA (and drug regulators in Europe) decided to essentially take Avandia off the market (completely in Europe and severely restricting it in the US). The FDA also used the occasion to announce a requirement for drug companies to conduct longer trials (2 years) to show that their diabetes drugs don’t have adverse heart effects. And now they’re doing the same thing with another diabetes drug, Bydureon, which the FDA just declined to approve. According to the manufacturers, the FDA wants them to conduct additional 2-year studies, specifically looking for adverse cardiac effects. (http://prescriptions.blogs.nytimes.com/2010/10/19/f-d-a-rejects-new-diabetes-drug/?ref=health).

The New York Times has been tracking the FDA’s recent trend toward increased regulation. This recent article looks at bisphosphonates (as well as Avandia) and brings up the larger issue of how to regulate drugs used to treat chronic diseases:
http://www.nytimes.com/2010/10/17/health/policy/17drug.html?hpw

The long-term, chronic use strikes me as an interesting dilemma, because our normal studies (pre drug approval) can only span a limited amount of time. Recently, the FDA has been prompted to act on Avandia and other drugs by the findings of academic researchers. But the FDA shouldn’t rely only on academics to do these studies. And, it’s generally harder to restrict drugs after they are already on the market anyway (although the FDA is willing to do so in some cases). Now that the FDA has the power to require studies after they have approved drugs, should they use this a primary regulation tool? Or should they require longer studies before approval? A combination?