From: David S. Leland [dleland@cogsci.ucsd.edu]
Sent: Friday, September 06, 2002 3:27 AM
To: fdadockets@oc.fda.gov
Subject: Comments on 02N-029-Request for Comments on First Amendment
Issues

Greetings,

	My name is David Leland, and I live at 9260-K Regents Road in La Jolla, CA 
92037.  Here are my comments regarding 02N-029-Request for Comments on 
First Amendment Issues.  I present them in bullet form.

Regarding corporate rights and commercial speech:

* The FDA's position should be that public health takes priority over 
commercial speech considerations, and the agency should do everything it 
can to defend its authority to restrict commercial speech in the effort to 
protect public health.

* The FDA should emphasize that commercial speech serves promotional 
purposes much more than educational ones. These promotional purposes do not 
deserve constitutional protection and -- even when not technically 
untruthful or misleading -- may by omission, emphasis or emotional appeal 
spur consumer purchasing patterns that are contrary to public health goals.

* The courts rationalize commercial speech protections on the grounds that 
commercial speech provides information to the public. If this is the goal 
-- rather than protecting an inherent right to advertise -- it makes sense 
for the government to make determinations about whether the commercial 
information actually will educate the public to advance public policy 
goals. In many instances, this will not be the case. And regulatory 
agencies are in better position to make such determinations than the courts.

* If there are going to be commercial speech protections, it should be 
enough for the FDA or other federal agencies to show that regulations 
reasonably work to directly advance legitimate governmental goals. The FDA 
and other agencies should not be subject to a "least restrictive" test, 
where they are forced to show that there was no less speech restrictive 
means to achieve their goal. One can always imagine less speech restrictive 
means -- even if they are politically unachievable or would fail to work in 
practice.

* Overly broad commercial speech protections will inappropriately transform 
legislative or regulatory decisions about public health issues into 
constitutional issues. (This is an argument Justice Breyer made in dissent 
in Western States Medical Center.)

* Corporations should not have any constitutional protections, since they 
are not, in fact, natural persons, flawed Supreme Court rulings 
notwithstanding.  Commercial speech should not receive constitutional 
protection, and while the FDA must contend with the fact that it currently 
does, it should press as hard as possible against existing limitations in 
these areas.  The mandate of the FDA is not to protect speech of any kind, 
but to do all in its power to protect the health and safety of citizens.

Regarding Direct-to-Consumer Pharmaceutical Advertising:

* While it is vital that consumers be empowered with information about 
pharmaceuticals, DTC ads are about promotion, not education.

* Many DTC ads understate safety risks, which is likely to lead to 
inappropriately increased consumer demand.

* Much of the public mistakenly believes DTC ads receive special clearance 
from the FDA -- and that only the safest drugs can be advertised on 
television -- leaving consumers vulnerable to and overly trusting of DTC 
promotions.

* DTC ads generally fail to provide key information to consumers: success 
rate for the drug, alternative treatments, how long the drug must be used.

* Evidence shows that physicians are influenced by advertising to make poor 
prescription decisions; consumers are similarly affected.

* DTC ads encourage consumers to demand brand-name products from doctors. 
Evidence suggests doctors are influenced by these demands, and sometimes 
prescribe requested medicines despite ambivalence about the choice of 
treatment.

* DTC ads encourage consumers to buy needlessly expensive products instead 
of cheaper generics, burdening the overall health care system.

* Given the proliferation of DTC advertising, the widespread abuses, and 
the paucity of evidence suggesting DTC ads contain significant educational 
information or improve patient well-being, the FDA should be moving in the 
direction of more rather than less regulation of DTC ads.

* The FDA should issue regulations specifically for DTC advertising, to 
establish clear rules for what is and is not permitted.

* One important step would be pre-review by the FDA of ads; the current 
system relies on self-restraint by drug manufacturers and a very inadequate 
and underfunded system of FDA warning letters sent after offending 
advertisements are aired or published.

* DTC advertisers should be required to run corrective ads after receiving 
FDA warning letters.

* Consumers should be empowered with useful information. This should be 
provided by FDA on the Internet, in inserts included with pharmaceuticals, 
and elsewhere. The information should be written in easy-to-understand 
language, and include information on success rates, and comparative 
efficacy and pricing data. This is how consumers' right to know should be 
satisfied, not through promotional advertisements that are inevitably slanted.

Regarding Tobacco Advertising:

* While the FDA does not currently have jurisdiction over tobacco, there 
are numerous initiatives to give the agency such jurisdiction -- including 
some legislative proposals favored by the tobacco industry -- and good 
reason to expect Congress will confer jurisdiction in the near future. FDA 
should consider the issue of tobacco advertising in determining its posture 
on commercial speech issues.

* There is an abundance of evidence that tobacco advertising has extremely 
harmful consequences, leading to increased smoking rates, especially among 
youth.

* Studies have found that:
- advertising campaigns using universal themes -- not just those obviously 
directed at youth -- are effective at luring youth into smoking;
- the same advertising that encourages or discourages brand switching is 
also effective at convincing new smokers to start;
- even very young children have enormous recall of cigarette brands and 
advertising, thanks to industry marketing efforts;
- internal industry documents show Big Tobacco is acutely aware of the 
importance of advertising and marketing in seducing new smokers.

* Appropriate public health policy would involve a complete prohibition on 
tobacco advertising and marketing. Lesser measures might include various 
bans on restrictions on particular types of advertising most likely to 
reach kids. There are significant public health benefits to be obtained 
from restrictions on advertising that could probably not be justified on 
the grounds that they are untruthful or misleading.

* Moreover, there is a wide array of desirable tobacco control measures 
(such as cigarette tax increases). If every advertising restriction must 
show it is the least-speech-restrictive means to lessen smoking, a court 
could argue that one or another of these alternatives should be used in 
place of restrictions on advertising. It is thus crucial that FDA work to 
advance a constitutional jurisprudence that is less protective of marketing.

* There is wide international support for advertising bans -- or at least 
severe advertising restrictions -- based on overwhelming evidence of the 
public health benefits from outlawing tobacco advertising.

Thank you for your consideration of my comments.
David Leland