IP: Response to Hotwired's "FDA Regulating the Net"

[Dave Farber <farber () cis upenn edu>]

Date: Tue, 29 Oct 1996 15:00:47 -0500 (EST)
From: schwartj <schwartj () twp com>
To: Dave Farber <farber () central cis upenn edu>
Subject: Response to Hotwired's "FDA Regulating the Net"




  I don't remember whether you sent out the Hotwired piece by Declan
McCullagh on the FDA's seminar on Internet marketing, but if you did I
responded to it (and other Net discussions of the FDA initiative) in my
column on Monday. Here's the text:


HEADLINE:  THE BOUNDS OF FREE SPEECH AND INTERNET ADVERTISING


COLUMN:  NETWORKINGS


BYLINE:  John Schwartz


    Do you hear the alarm bells? These days, it seems, they are being rung
all the time, warning us that free speech on the Internet is in danger.
One of the latest such messages recently appeared on Wired Ventures'
on-line site, Hot&wired. "Pinstriped bureaucrats" at the Food and Drug
Administration, we were told, are "hatching their own schemes to regulate
the Net."


    What raised the hackles of Wired's defenders of Net freedom was a
recent two-day conference hosted by the agency, "FDA and the Internet:
Advertising and Promotion of Medical Products." In the Hotwired report,
writer Declan McCullagh decried the "benevolent paternalism" underlying
the conference -- the notion, he said, that "consumers can't be trusted to
make their own choices."


    As The Post's beat reporter for the FDA, I'd figured out a long time
ago that I cover the agency everyone loves to hate. House Speaker Newt
Gingrich (R-Ga.) has accused the FDA of squelching both business
opportunities and potentially lifesaving innovations through over-caution;
columnist George Will recently said the agency's actions were emblematic
of what he calls the "nanny state."


    These two men, like many of the FDA's critics, are familiar with how
the agency works; they would like to change it. But the on-line attack
from Hotwired bears the blemishes of a lot of reporting one finds on the
Net: heavy on attitude, light on knowledge.


    McCullagh noted that drug company representatives at the FDA meeting
"appeared less than overly concerned with regulatory threats to free
speech." That's not surprising, since in their minds it's not an issue of
free speech, but of adapting the regulatory world they've already got to a
new electronic dimension.


    Now, the First Amendment puts the grits on my table. And I'm an
Internet kind of guy as well. But the First Amendment doesn't mean
anything goes, whether on the Net or in what some wired folks call
"meatspace" (the real world). As it has been interpreted by the courts for
years, the First Amendment doesn't protect lies, and it doesn't protect
obscenity, and it doesn't prohibit government from regulating what's known
as "commercial speech."


    I put the FDA question to Bruce J. Ennis, a Washington attorney and
First Amendment expert who's been very active in issues of free speech in
cyberspace, notably as lead lawyer for the coalition that succeeded in
striking down the Communications Decency Act. That law regulated
"indecent" material in the on-line world.


    He notes there has been talk in the legal world that speech should be
freer on the Internet than in other places, on the grounds that it's an
inherently more democratic medium than others. Even so, he says: "There's
no reason to think that the government will be completely disabled from
regulating in the Internet the very same speech it could regulate in
print."


    The FDA has long regulated the ways companies pitch their products,
especially in the sensitive area of marketing directly to consumers.
Companies have to prove that a drug is safe and effective for the intended
use, and to inform consumers of side effects and other problems. The
agency argues that these regulations help ensure that consumers get the
information they need to make informed choices -- and also help limit
fraud.


    Those laws sometimes lead to odd results. They are the reason why, as
Post columnist Tony Kornheiser noted last week, it's hard to figure out
from the ads what the new pharmaceutical Claritin does. Getting the
side-effects information into ads on television or Metro placards is
impractical, so companies often compromise by getting the product name out
there without making specific claims, trusting consumers to work out the
rest for themselves with their doctors. (Claritin is an antihistamine.)


    Alisa Bernstein, a senior science policy adviser for the FDA, told me
the Internet guidelines being considered by the agency would apply only to
companies attempting to promote their products over the Internet, formally
applying the rules of advertising in other media to the new one. The rules
would not affect individuals involved in, say, on-line discussions of
medical therapies.


    Bernstein said advertising on the Internet will provide new
opportunities for companies, since the required consumer information can
be provided painlessly through the World Wide Web's hypertext links. "We
recognize that the Internet is a useful and powerful tool to disseminate
information," she said. "We don't want to hinder the flow of information."


    The FDA's powers to regulate commercial speech, even in print, aren't
universally supported. The Washington Legal Foundation, a think tank that
gets funding from regulated industries, opposes them. And Sen. Bill Frist
(R-Tenn.) has pushed a bill to allow drug companies to distribute
scientific materials to doctors about unapproved uses for their products.


    Ultimately, this debate isn't about speech. It comes down to how much
regulation we want.


     John Schwartz's e-mail address is schwartj () twp com PLACES TO GO






    The Food and Drug Administration's   website (www.fda.gov) has
background material on its legislative mandate and issues as well as
up-to-date information on coming advisory panel meetings and product
approvals. For a critical view of the agency, try the FDA "reform" page
created by the leading trade group for medical device manufacturers: www.
himanet.com/industry/fdareform-main.htm. The Progress and Freedom
Foundation has an FDA page at www.pff.org/pff/i-mip.html.