Calfee: FDA regs, First Amendment not in sync


A "vast portion" of Food and Drug Administration regulations don't square
with the First Amendment, Jack Calfee of the American Enterprise Institute said
Thursday. So why isn't there a parade of lawsuits challenging them?

Calfee suggested that in the case of drug companies, they need to keep good
relations with the agency over more pressing concerns, like new drug approvals.
Absent the legal challenges that would promote change, he said, some structural
changes are necessary.

David Vladeck, representing Public Citizen, countered that the reason for the
lack of challenges was that there wasn't anything wrong with the FDA approach,
which requires that the truthfulness of a claim be proved before the speech is
accepted. He said the FDA should do nothing rather than making any wholesale

Calfee and Vladeck were among a number of panelists discussing the balance
between regulating prescription-drug ads and protecting commercial speech.

The forum was a Media Institute luncheon in Washington, D.C., and the impetus
was the FDA's request for help in deciding whether and how it might change its
approach to regulating speech about prescription drugs. That soul-searching was
prompted, in part, by a court case throwing out an FDA ban on certain types of
drug advertising.

C. Lee Peeler, representing the Federal Trade Commission, suggested the FTC
model of allowing speech, then taking action against deceptive speech.

Vladek countered that such an approach is too risky when public-health issues
are at stake.