Q&A on the FDA Request for Comment on First Amendment and Commercial Speech Issues

What is the FDA's Request for Comment?

When are comments due?

How do I submit comments?

What should I say in my comments?

How should I present my comments?

What is the existing law with regard to commercial speech?

Why shouldn't commercial speech have strong constitutional protections?

Relevant FDA Notices and Related Material

Relevant FDA Notices and Related Material

Suggestions for Submitting Comments

On corporate constitutional rights and commercial speech

On Direct-to-Consumer pharmaceutical advertising

On Tobacco advertising

Background Infromation

Corporate Constitutional Rights and Commercial Speech

Direct-to-Consumer Pharmaceutical Advertising


If you are interested in the general issue of corporate rights or commercial speech, you might want to consider saying:

* 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.)

* Because corporations should not have any constitutional protections, and because commercial speech should not receive constitutional protection, the FDA should press as hard as possible against existing limitations in these areas. (You may want to elaborate on why you believe there should be no constitutional protections for corporations, or constitutional guarantees for commercial speech.)

If you are providing comments in the general area of constitutional protections for corporations or commercial speech, you should remember that the FDA must comply with the U.S. Constitution and Supreme Court interpretations.

While you may oppose the application of constitutional protections for corporations, or any constitutional protections for commercial speech -- and you should definitely feel free to express this opposition in your comments -- keep in mind that right now corporations do have constitutional protections, and that the FDA must respect this. It may be particularly useful to make the argument that corporations and commercial speech should have no constitutional protection; and then, recognizing that they do under existing court decisions, say that the appropriate response of the FDA is to push as hard as possible against the limits of these misguided constitutional protections.

Home | Essential Action