“Off-label” prescribing—that is, doctors prescribing drugs for purposes other than those expressly approved by the Food and Drug Administration (FDA)—is often useful although little is known of its extent. In the last several years, nearly every major pharmaceutical company has paid hundreds of millions of dollars to settle allegations of illegal marketing of drugs for off-label uses. There has been a growing trend of actions by federal prosecutors, state attorneys general, and cooperating trial lawyers to litigate against pharmaceutical manufacturers for allegedly doing too much to promote off-label use of prescription products. Citing recent legal changes mandating exclusion from federal programs after a conviction, many manufacturers say they are forced to settle rather than risk defending themselves—even as prosecutions against individual executives have foundered in front of juries. 

At this AEI Legal Center event, experts on both law and health care will present papers on the law, economics, medicine, and public policy of off-label marketing, discussing everything from off-label prescribing and the abuse of class action mechanisms to implications for the First Amendment and medical malpractice. Speakers include former FDA chief counsel Daniel Troy; former Cephalon general counsel John Osborn; former deputy attorney general George Terwilliger; principal deputy assistant attorney general and acting assistant attorney general for the Civil Division Jeffrey Bucholtz; attorneys Brian Anderson, James Beck, Mark Herrmann, Richard Samp, and Kyle Sampson; law professor Margaret Johns; and AEI scholars John E. Calfee, Theodore H. Frank, and Scott Gottlieb. The session will begin with results from a new survey of oncologists about off-label prescribing and information about off-label uses. 

8:30 a.m.	Registration and Breakfast
8:45		Panel I: Off-Label Prescribing, Marketing, and Medical Practice
	Presenters:	John E. Calfee, AEI
		Scott Gottlieb, M.D., AEI
	Discussants:	Len Lichtenfeld, American Cancer Society
	Moderator:	Cole Werble, RPM Report
10:30		Panel II: The Legal Environment from Federal Regulation and Enforcement
	Presenters:	John Osborn, University of Oxford
		George Terwilliger, White & Case
		Daniel Troy, Sidley & Austin
	Discussant:	Jeffrey S. Bucholtz, Department of Justice
	Moderator:	Theodore H. Frank, AEI
12:30p.m.	Luncheon
1:15		Panel III: Distortions from State and Private Enforcement
	Presenters:	Brian Anderson, O’Melveny & Myers
		Theodore H. Frank, AEI
		Kyle Sampson, Hunton & Williams
	Discussant:	Michael S. Greve, AEI
	Moderator:	Michael A. Krauss, George Mason University Law School
3:15		Panel IV: Legal Implications for Commercial Speech and Medical Practice
	Presenters:	James Beck, Dechert
		Mark Herrmann, Jones Day
	Discussants:	Margaret Johns, UC Davis School of Law
		Richard Samp, Washington Legal Foundation
	Moderator:	John E. Calfee, AEI
5:00	Adjournment