November 15, 2008
As I see it
As the Obama transition team focuses on the nation's highest priorities, don't think for a moment that drug marketing issues will get a pass come Inauguration Day.
With healthcare promises near the top of his agenda, expect Obama operatives to work closely with Capitol Hill counterparts to undo the prohibition on negotiating Medicare drug prices, even if work on the national deficit diverts attention from the notorious “doughnut hole” in seniors' drug benefits.
Although there was hardly any mention of the FDA on the campaign trail, Team Obama's reforms for that agenda will be set by Democrats on Capitol Hill who have a laundry list of things to change, including the composition of outside advisory committees to lessen industry influences, attention to drug safety in the early phases of new product development and review, and more attention to whistleblower complaints.
A Supreme Court decision favoring industry in Wyeth v. Levine is likely to provoke swift congressional countermeasures if it gives the FDA blanket pre-emption authority like that awarded last February for medical device makers. Nevertheless, readers of Supreme Court judicial banter tea leaves have a poor batting average when it comes to predicting case outcomes, so when the decision comes down, Democratic bills to answer it will be ready, and to undo the device preemption decision in Riegel v. Medtronic as well.
And as one anonymous but apparently informed FDA blogger put it, the core issue in Wyeth v. Levine wasn't the failure of the FDA-approved label to warn, but its failure to contraindicate the IV-push technique that caused the harm.
James G. Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)