Does Avandia Decision Signal New FDA? Or Same Old Agency?

The Europeans are suspending sales of the controversial diabetes drug Avandia because of evidence it may cause serious heart problems.

American regulators are letting it stay on the market, with restrictions.

So is this a stark example of the same old wimpy, industry-driven U.S. Food and Drug Administration? Or does it signal a turn toward taking action to protect consumers when the data suggest (but don’t prove) that a popular drug may be risky?

You’ll hear reactions both ways in the next few days.

Consumer Reports calls the FDA’s decision disappointing, and lauds the European Medicines Agency’s more forthright step.

“Europe has taken Avandia off the market, which is what the FDA should have done,” e-mails Diana Zuckerman, who represents a consortium of consumer groups.

There may be fewer differences between the action taken by European and U.S. regulators than you might think at first glance.

By clamping such serious restrictions on who can get Avandia in the future, the FDA has essentially killed the once-upon-a-time blockbuster. Even its maker GlaxoSmithKline conceded as much.

In a statement, Glaxo said it “will voluntarily cease promotion of Avandia in all the countries in which it operates and will continue to respond to requests for information and support from healthcare professionals and patients.”[…]

Read the full article here.