As I see it

Share this article:
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) 
Share this article:
close

Next Article in As I See It

Email Newsletters

More in As I See It

As I See It: Access to data

As I See It: Access to data

We need for pharmaceutical companies to come forward and make the pledge to stop hiding data

As I See It: FDA and the First Amendment

As I See It: FDA and the First ...

FDA's Warning Letter to Aegerion is a bureaucratic thumb in the eye to the US Court of Appeals

As I See It: Small is the new Big

As I See It: Small is the new ...

It's fast becoming an n of 1 world, where every disease is an orphan disease and success is measured by individual outcomes