As I see it

Share this article:

As the Bush administration prepares to eke out its last months in office, there is a sense of urgency that it should leave a judicially backed policy that FDA approval pre-empts state laws on product liability. Failure would give a Democratic administration a good opening to begin undoing the Bush gains, one of which came in February when the Supreme Court established FDA pre-emption of medical device lawsuits.

In March, the high court dodged a Michigan case that might have done the same for drugs, deferring to a newer case involving Wyeth's Premarin on which it is expected to rule by fall. FDA pre-emption for both drugs and devices would be a blow not only to the lucrative, company-devastating trial attorneys and their favorite political party (Democrats) but also to the FDA, which has been directed by the Bush administration to go against its own best interests and to support pre-emption in legal briefs and speeches.

In its Clinton administration days and before, the FDA quietly supported state product liability litigation as adjunctive to its always-meager enforcement efforts.

Without filing briefs on the side of plaintiffs, the agency informally encouraged state-level sanctions against violative firms because it knew its enforcement resources could never be adequate to its vast statutory mandate.

Former commissioner David Kessler, a Republican appointee, and Georgetown law professor David Vladeck recently amplified further in a Georgetown law journal article, pointing out that FDA approval is the beginning, not the end of product safety concerns; approval should not insulate marketers from legal consequences. The FDA's ability to assert consequences is much diminished these days. I suspect none of this will slow down the insulators between now and Inauguration Day.

Dickinson is editor of Dickinson's FDA Webview (

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in As I See It

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in As I See It

As I See It: Patient Centricity

As I See It: Patient Centricity

A patient who is diagnosed earlier and receives the most efficacious treatment is the least expensive

As I See It: FDA's social-media moves

As I See It: FDA's social-media moves

FDA has insisted that its antique regulations can address every new promotional challenge

As I See It: FDA and marketing materials

As I See It: FDA and marketing materials

The more clarity that FDA provides, the more confident companies can be in their medical communications