QUESTIONS AND ANSWERS ON THE FDA REQUEST FOR COMMENT ON FIRST AMENDMENT
AND COMMERCIAL SPEECH ISSUES

What is the FDA's Request for Comment?

The FDA has issued a request for comment in relationship to issues involving the First Amendment and commercial speech protections. In light of recent court decisions expanding commercial speech protections, the FDA asks how it should regulate advertising.

Essential Action is worried that the request for comment is part of an FDA agenda to scale back its regulatory authority, and to defer to an inappropriate and very high level of protection for commercial speech.

The FDA is asking for broad comments on First Amendment and commercial speech issues, and has also posed a set of nine specific questions (contained in the formal request for comment). You can comment on the broad issues, and address any, all or none of the specific questions.

When are comments due?

Comments are due by September 13. The FDA will accept responses to comments until October 28.

How do I submit comments?

You can submit comments by mail to:

Dockets Management Branch,
Food and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Send two copies.

Or, you can submit comments electronically, at http://www.fda.gov/dockets/ecomments and then scrolling to "02N-0209-Request for Comments on First Amendment Issues"

or, by going directly to the form.

What should I say in my comments?

You should tailor your comments around your areas of interest and opinion. You do not need to be an "expert" to offer comments, and you do not need to offer elaborate comments. You should feel free to borrow any or all of the ideas detailed below. If you can express them in your own words, that's best. But it is fine to copy the exact language we use.

Our suggestions on what to say about corporate rights and commercial speech are here.

Our suggestions on what to say about Direct-to-Consumer pharmaceutical advertising are here.

Our suggestions on what to say about tobacco advertising are here.

How should I present my comments?

If you submit your comments electronically, the FDA's form will unfortunately ask you to submit answers in response to the specific set of questions they have raised. If you have comments in response to any or all of their specific questions, you should include your answers in those boxes.

If you are submitting electronically and want to submit general comments, or comments on matters not directly raised by the FDA's questions, you should enter your comments in response to either question one or nine. The FDA has asked for general comments, so you should not feel reluctant to offer comments that are not directly responsive to their specific questions.

If you are submitting comments by mail, you should write your comments in letter form, presenting your arguments however seems most logical to you.

What is the existing law with regard to commercial speech?

Under current U.S. Supreme Court rulings, commercial speech limitations must pass a test developed in a case called Central Hudson. The first prong of the Central Hudson test is whether the speech concerns legal activity (e.g., there is no right to advertise sale of cocaine), and is neither untruthful nor misleading. Assuming the speech concerns legal activity and is not misleading, the courts ask whether governmental restrictions on speech serve a "substantial" government interest, whether the regulations directly advance the governmental interest asserted, and "whether it is not more extensive than necessary to serve that interest."

In recent years, including an important case decided earlier this year called Thompson v. Western States Medical Center, the Supreme Court has interpreted this test to make it increasingly difficult to defend limits on commercial speech.

For more on the recent case, click here
< http://lists.essential.org/pipermail/corp-focus/2002/000126.html >

For more on the history of commercial speech protections, click here.
< http://www.multinationalmonitor.org/mm1998/98may/corp3.html>

Why shouldn't commercial speech have strong constitutional protections?

The First Amendment is the bedrock of the U.S. democratic system, because it protects the right to dissent, to organize politically, to practice religion and to express oneself -- not to advertise.

There are important public policy reasons to limit advertising in general, and in particular areas. Advertising spreads commercial values, and displaces alternatives. In addition to promoting particular products, ads buttress corporations' political power by making them seem omnipresent and an integral part of everyday life. Advertising may have particularly pernicious impacts on children, who are uniquely vulnerable to product promotions, and who may become excessively focused on materialistic desires. Some of our general views on this are here.

In specific areas -- including pharmaceuticals, tobacco, health-related claims on foods, gambling -- there may be important reasons for particularized advertising restrictions. We supply some rationales for restricting pharmaceutical and tobacco advertising here.

We also believe that Constitutional protections properly apply to people, not corporations. Commercial speech protections are effectively a constitutional guarantee unique to corporations, which do most commercial advertising.

We acknowledge that there are some educational benefits to some commercial advertising, but do not believe that these benefits should be afforded Constitutional protection, especially given the notable benefits to restricting advertising. We favor evolution of a doctrine of the public's right to know -- mandating disclosure and easy-to-understand publication of various types of public and private information -- but we do not believe commercial speech Constitutional protections do anything to further this goal.