PointofLaw.com
 Subscribe Subscribe   Find us on Twitter Follow POL on Twitter  
   
 
   

 

 

Trial lawyer earmark in FDARA?



AEI's Scott Gottlieb, the former FDA commissioner, writes in the Wall Street Journal:

Democrats staged an 11th-hour showdown this week over a bill that funds the Food and Drug Administration (FDA). Their aim: a huge handout to the trial bar.

The furtive give-away is buried in the Food and Drug Administration Revitalization Act (FDARA), a funding bill that needs to pass this week if the agency is to avoid a budget crunch that could force it to fire its drug reviewers. If drug safety is so critical, why would Democrats risk issuing pink slips at the FDA? The provision raises the question of whether the hyperbole and hearings over drug safety these past several years was about improving public health, or merely paying off the lawyers.

The key issue is whether state courts should second-guess FDA scientific decisions that are based on an exhaustive review of clinical data and the proposed drug labeling. This usually comes up when drug companies are alleged to have failed to warn consumers about emerging drug safety issues, which comprise the vast majority of product liability cases.

Companies and the FDA (under both Republican and Democratic administrations) have argued that when the FDA specifically addresses a safety issue -- often telling companies that they can't include certain warnings in drug labeling because it's not scientifically justified -- state courts are "pre-empted" from and have no business substituting their judgment for the agency's expert finding. Otherwise, drug labeling -- which is an important public health tool -- would get cluttered with dubious and confusing warnings aimed at only shielding firms from lawsuits.

One recent case where pre-emption was successfully asserted was Dowhal v. SmithKline Beecham in California. The company was sued for failing to warn consumers that nicotine-replacement products allegedly cause birth defects, even though there wasn't any credible scientific evidence establishing that link. The FDA not only forbade SmithKline Beecham from including the superfluous warning in the drug's label, it also said that the public health was best served by encouraging pregnant woman to use nicotine replacement instead of smoking.

A California court initially said that more warnings were always better. Fortunately, after the FDA asserted that its judgment should prevail, the California Supreme Court unanimously agreed.

Relatedly, AEI's Jack Calfee critiques FDARA.

Related Entries:

 

 


Isaac Gorodetski
Project Manager,
Center for Legal Policy at the
Manhattan Institute
igorodetski@manhattan-institute.org

Katherine Lazarski
Press Officer,
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.