Henry Waxman and Ed Markey have just introduced a companion to a Senate safety bill championed by Ted Kennedy and Mike Enzi, but it goes further in several ways.

For instance, the House bill would ban DTC ads on new drugs for three years, not two years. Both bills calls for reviews three years after a drug’s approval, but the House proposal would require an additional review four years later. The House bill would also establish fines of at least $50,000, but no greater than either $1 million or 10 percent of a drug’s annual sales, while the Senate bill, which also caps fines at $1 million, establishes minimum fines at $15,000.

But there is a shortcoming - the House bill stops short of calling for a separate Office of Drug Safety at the FDA, which is something that Chuck Grassley and Chris Dodd have been pushing in a different Senate bill. Their rationale is to minimize agency interference with its medical reviewers, some of whom have complained that FDA politics repeatedly hinder their work.

Support for this concept seems to be waning. Consumers Union, for instance, backs the Waxman-Markey bill, just as it supports the Kennedy-Enzi bill. That’s too bad. Despite the provisions, these legislative efforts don’t go far enough to ensure agency staffers can do their jobs. File this under missed opportunity.

Letter from Consumers Union.
Story from Reuters.
The Kennedy-Enzi bill.
The Grassley-Dodd bill.

Waxman and Markey, so far, failed to post the bill. When they do, Pharmalot will provide the link.

[tags]Drug Safety, Ed Markey, FDA, Henry Waxman[/tags]