[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]
Panel 1: FDA in a Changing World: Lewis Grossman, Ted Ruger, Barbara Evans, moderated by Holly Fernandez Lynch
Lewis Grossman, FDA in the Age of the Empowered Consumer
Begins his analysis by comparing a hypothetical consumer in 1960 and today.
Consumer was passive. Today’s consumer is active, more unmediated choice, more direct citizen involvement.
Why the change? 1970 was the decade of advocacy, culminating in 1972 Patient’s Bill of Rights from AMA. Central them was informed consent and thus complete information from physician.
1998 saw disruption of WebMd and now even more disrupted by web search technology which is how most patients get there info.
Food: 1966, recipe standards. Relatively little variety and consumer choice. Very little info on nutrition, “batman white bread.” Turning point was 1969 White House conference that led to more choice and more info.
Health clams as the portal where 1st Amendment law entered into FDA law. The image of the intelligent consumer who need not be shielded from information.
Changes in standard by which FDA decided if something was misleading. Until 2002 unsure if reasonable or gullible consumer standard. In 2002 for food FDA chose the reasonable consumer standard.
Liberal and conservatives got scrambled on these matters in interesting ways.
Also a revolution in advertising, leading to revolution of patient’s relationship to his or her drugs.